Clozapine is an antipsychotic medicine. It works by changing the actions of chemicals in the brain.

Clozapine is used to treat schizophrenia in adults after other treatments have failed.

Clozapine is also used to reduce the risk of suicidal behavior in adults with schizophrenia or similar disorders.

Warnings

Clozapine affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, sore throat, weakness, or lack of energy.

Clozapine can increase your risk of seizure, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

Clozapine can cause serious heart problems. Call your doctor right away if you have chest pain, trouble breathing, fast or pounding heartbeats or sudden dizziness.

Clozapine is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

Clozapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

You should not take clozapine if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart problems, high blood pressure,
• a heart attack or stroke (including “mini-stroke”);
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• a seizure, head injury, or brain tumor;
• diabetes, or risk factors such as being overweight or having a family history of diabetes;
• high cholesterol or triglycerides;
• constipation or problems with your bowel movements;
• liver or kidney disease;
• an enlarged prostate or urination problems;
• glaucoma;
• malnourishment or dehydration; or
• if you smoke.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop taking clozapine without your doctor’s advice.

You should not breastfeed while using this medicine.

Clozapine is not approved for use by anyone younger than 18 years old.

How should I take clozapine?

Take clozapine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take clozapine with or without food.

Shake the oral suspension (liquid) for 10 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Clozapine affects your immune system and can have long lasting effects on your body. You may get infections more easily, even serious or fatal infections. You may need frequent medical tests while using this medicine and for a short time after your last dose.

You should not stop using clozapine suddenly. Follow your doctor’s instructions about tapering your dose.

If you start taking clozapine again after 2 or more days off the medicine, you may need to use a lower dose than when you stopped. Follow your doctor’s dosing instructions very carefully.

Your doctor may recommend you use a laxative while taking clozapine. Use only the type of laxative your doctor recommends.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Schizophrenia:

Initial dose: 12.5 mg orally once or twice a day
Titration and Maintenance dose: May increase total daily dose in increments of 25 mg to 50 mg per day to a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of week 2. Subsequent dose increases can be in increments of up to 100 mg once or twice weekly.
Maximum dose: 900 mg per day

Comments:
-The absolute neutrophil count (ANC) must be 1500/microL or greater for the general population and at least 1000/microL for patients with documented Benign Ethnic Neutropenia (BEN) prior to initiating treatment; to continue therapy, the ANC must be monitored regularly.
-A low starting dose, gradual titration, and divided doses are necessary to minimize the risk of orthostatic hypotension, bradycardia, and syncope.
-When therapy is interrupted for 2 or more days, re-initiate with 12.5 mg once or twice a day; based on tolerability, a dose that is restarted may be increased to a previously therapeutic dose more quickly than it was for initial treatment.

Uses:
-For the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment
-To reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder, who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

If you miss taking clozapine for more than 2 days in a row, call your doctor before you start taking it again.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, confusion, fast heartbeats, feeling light-headed, weak or shallow breathing, drooling, choking, or seizure.

What to avoid

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine.

Avoid driving or hazardous activity until you know how clozapine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Clozapine side effects

Get emergency medical help if you have signs of an allergic reaction to clozapine (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, flu-like symptoms, extreme weakness;
• mouth sores, skin sores;
• new or worsening cough, trouble breathing;
• pain or burning when you urinate; or
• vaginal itching or discharge.

Further doses may be delayed until your infection clears up.

High doses or long-term use of clozapine can cause a serious movement disorder that may not be reversible. The longer you use clozapine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Clozapine can increase your risk of seizure, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• a seizure (blackout or convulsions);
• severe constipation;
• dry or hard bowel movements, or painful gas;
• nausea, vomiting, stomach pain or bloating;
• heart problems – chest pain, fast or pounding heartbeats, fluttering in your chest, slow heartbeats, shortness of breath, and sudden dizziness (like you might pass out);
• liver problems – loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Untreated constipation may lead to serious bowel complications, hospitalization, or death. Tell your doctor right away if you are not having bowel movements at least 3 times per week.

Common clozapine side effects may include:

• weight gain;
• dizziness, tremor;
• fast heart rate;
• headache, drowsiness;
• nausea, constipation;
• dry mouth, or increased salivation;
• vision problems; or
• fever, increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect clozapine?

When you start or stop taking clozapine, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Clozapine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using clozapine with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, cold or allergy medicine, or medicine for anxiety or seizures.

Many drugs can affect clozapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Caplyta is used to treat adults with schizophrenia, depression associated with bipolar I or bipolar II disorder (manic depression), or along with antidepressant medicines to treat major depressive disorder (MDD). Caplyta is a once-daily capsule. When used to treat bipolar disorder, this medicine can be used alone or with lithium or valproic acid.

Clinical trials have reported improvement in the positive and negative symptoms of schizophrenia within one week of starting Caplyta (lumateperone), but symptoms may take longer to resolve when used for depression .

Important Information

Caplyta carries a Boxed Warning for increased risk of death in elderly patients with dementia-related psychosis and an increased risk of suicidal thoughts and behaviors in younger patients.

• Increased risk of death in elderly people with dementia related psychosis. Medicines like Caplyta can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Caplyta is not approved for the treatment of people with dementia-related psychosis.
• Increased risk of suicidal thoughts and actions. Caplyta and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
  • Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when Caplyta or the antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• • Thoughts about suicide or dying
  • New or worse depression
  • Feeling very agitated or restless
  • Trouble sleeping
  • Acting aggressively, being angry, or violent
  • An extreme increase in activity and talking (mania)
  • Suicide attempts
  • New or worse anxiety
  • Panic attacks
  • New or worse irritability
  • Acting on dangerous impulses
  • Other unusual changes in behavior or mood.

Side Effects

Common side effects

The most common side effects of Caplyta are:

• Sleepiness
• Dizziness
• Nausea
• Dry mouth
• Feeling tired
• Diarrhea.

Caplyta may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

Caplyta does not appear to be associated with weight gain like many other antipsychotics are.

Serious Side Effects

Caplyta can also cause the following other serious side effects:

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis, which can lead to death. Caplyta is not approved for the treatment of people with dementia-related psychosis.
• Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
  • High fever
  • Confusion
  • Changes in your breathing, heart rate, and blood pressure
  • Stiff muscles
  • Increased sweating.
• Uncontrolled body movements (tardive dyskinesia). Caplyta may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Caplyta. Tardive dyskinesia may also start after you stop taking Caplyta.
• Problems with your metabolism, such as:
  • High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Caplyta. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start Caplyta, and then regularly during long-term treatment with Caplyta.

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Caplyta:

• • • Feel very thirsty
    • Need to urinate more than usual
    • Feel very hungry
    • Feel weak or tired
    • Feel sick to your stomach
    • Feel confused, or your breath smells fruity.
  • Increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start Caplyta, and then periodically during treatment with Caplyta.
  • Weight gain. Weight gain is uncommon, but you and your healthcare provider should check your weight before you start and regularly during treatment with Caplyta.
• Low white blood cell counts. Your healthcare provider may do blood tests during the first few months of treatment with Caplyta.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position after taking Caplyta.
• Falls. Caplyta may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills, which may lead to falls that can cause fractures or other injuries.
• Seizures (convulsions). Caplyta may increase your risk of seizures.
• Sleepiness, drowsiness, feeling tired, difficulty thinking, and doing normal activities.
• Difficulty swallowing, which can cause food or liquid to get into your lungs. Tell your healthcare provider immediately if this happens.
• Problems controlling your body temperature so that you feel too warm.

This is not a complete list of Caplyta side effects, and others may occur. Call your doctor for medical advice about side effects.

How Does Caplyta Work?

Caplyta works by changing the activity of neurotransmitters in the brain, such as dopamine, glutamate, and serotonin, to increase or balance their levels. This helps to relieve symptoms such as hallucinations, delusions, and disorganized thoughts associated with schizophrenia, and low mood associated with depression. 

Caplyta belongs to the drug class called atypical antipsychotics.

Caplyta Cost and Insurance Coverage

Eligible patients may pay as little as $0 for 30-day or 90-day prescriptions with the Caplyta Savings Card. 

• Text Caplyta to 26789 to download a digital Caplyta Savings Card to your phone and receive useful text messages about your prescription.
• 90% of Americans with commercial insurance have coverage for Caplyta.
• Caplyta is covered for more than 99% of people with Medicaid and Medicare Part D.

Before taking this medicine

Do not use Caplyta if you are allergic to Caplyta, lumateperone, or any of the ingredients in the capsules. Caplyta may also increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Before taking Caplyta, tell your healthcare provider about all your medical conditions, including if you: 

• Have or have had heart problems or a stroke
• Have or have had low or high blood pressure
• Have or have had diabetes or high blood sugar, or a family history of diabetes or high blood sugar. 
• Have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
• Have or have had a low white blood cell count
• Have or have had seizures (convulsions)
• Have or have had kidney or liver problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

Caplyta may harm your unborn baby. Taking Caplyta during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take Caplyta during pregnancy.

• Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Caplyta.
• There is a pregnancy registry for females who are exposed to Caplyta during pregnancy. If you become pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to https://womensmentalhealth.org/research/pregnancyregistry/

Breastfeeding

Caplyta passes into your breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby during treatment with Caplyta.

Fertility

This medicine may affect fertility in both men and women.

How should I take Caplyta?

Take Caplyta as prescribed by your healthcare provider. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• Take Caplyta 1 time each day with or without food.
• You can take Capylta in the morning or at night, but try to take it around the same time each day.

What happens if I miss a dose?

Take Caplyta as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I take too much?

If you take too much Caplyta, call your healthcare provider or Poison Help Line or go to the nearest hospital emergency room right away.

Dosing Information

Dose of Caplyta for Schizophrenia

• 42 mg orally once daily with or without food.

Dose of Caplyta for Depression Associated with MDD or Bipolar I or II Disorder

• 42 mg orally once daily with or without food.
• Use in addition to antidepressants for MDD.
• Use as monotherapy or as adjunctive therapy with lithium or valproate for Bipolar I or II disorder.

Liver Impairment

• Moderate to severe liver disease: 21 mg orally once daily with or without food.

What to avoid while taking Caplyta?

Do not drive, operate machinery, or do other dangerous activities until you know how Caplyta affects you. Caplyta may make you drowsy.

Do not become too hot or dehydrated during treatment with Caplyta.

• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water

What other drugs will affect Caplyta?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Caplyta and other medicines may affect each other, causing possible serious side effects. Caplyta may affect the way other medicines work, and other medicines may affect how Caplyta works. Especially tell your doctor if you take:

• An antibiotic, antifungal, or antiviral medicine
• Blood pressure medication
• Bronchodilator asthma medication
• Cold or allergy medicine (Benadryl and others)
• Medicine to treat depression, anxiety, mood disorders, or mental illness
• Medicine to treat an overactive bladder
• Medicine to treat Parkinson’s disease
• Medicine to treat stomach problems, motion sickness, or irritable bowel syndrome
• Seizure medication

Brexpiprazole is used to treat major depressive disorder in adults (in addition to other medications), schizophrenia in adults and children aged 13 years and older, and agitation that may happen with dementia due to Alzheimer’s disease. It is an oral tablet taken once a day.

Brexpiprazole belongs to the drug class called atypical antipsychotics.

Brexpiprazole first gained FDA approval on July 10, 2015 under the brand name Rexulti. There is a generic brexpiprazole but it is only approved for adults with depression or schizophrenia. The brand Rexulti has additional approvals for adolescents 13 years and older with schizophrenia and for Alzheimer’s disease-related agitation.

Mechanism

Brexpiprazole works by correcting the imbalance of natural chemical messengers  (neurotransmitters), such as dopamine and serotonin in the brain. This imbalance is thought to be associated with several psychiatric disorders such as schizophrenia, depression, and agitation associated with Alzheimer’s disease.

Brexpiprazole uses

Brexpiprazole is an atypical antipsychotic used:

• along with antidepressant medicines to treat major depressive disorder (MDD) in adults
• to treat schizophrenia in adults and children ages 13 years and older
• to treat agitation that may happen with dementia due to Alzheimer’s disease.

Brexpiprazole should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

Clinical trials have not been conducted in children so it is not known if brexpiprazole is safe and effective for the treatment of MDD in children under the age of 18 or for the treatment of schizophrenia in children under 13 years.

Brexpiprazole side effects

The most common side effects of brexpiprazole are:

• weight gain
• sleepiness
• dizziness
• common cold symptoms
• restlessness or feeling like you need to move (akathisia).

Serious side effects and warnings

Brexpiprazole carries a Boxed Warning for an increased risk of death in elderly patients with dementia-related psychosis.

Increased risk of death in elderly people with dementia-related psychosis. Trials have reported medicines like brexpiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Brexpiprazole is not approved for dementia-related psychosis without agitation that may happen with Alzheimer’s disease.

Increased risk of suicidal thoughts and actions. Brexpiprazole and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

• Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when brexpiprazole or the antidepressant medicine is started or when the dose is changed.
• Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
• Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worsening depression
• new or worsening anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worsening irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity or talking (mania)
• other unusual changes in behavior or mood.

Other serious side effects of brexpiprazole include the following.

Cerebrovascular problems (these involve the blood vessels of the brain), including stroke, in elderly people with dementia-related psychosis that can lead to death.

Neuroleptic malignant syndrome (NMS), which is a rare and life-threatening reaction to antipsychotic drugs. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

• high fever
• stiff muscles
• confusion
• changes in your pulse, blood pressure, heart rate, and breathing
• increased sweating.

Uncontrolled body movements (tardive dyskinesia). Brexpiprazole may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking brexpiprazole. Tardive dyskinesia may also start after you stop taking brexpiprazole.

Brexpiprazole may also cause problems with your metabolism such as:

• High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take brexpiprazole. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start brexpiprazole and then regularly during long term treatment with brexpiprazole. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with brexpiprazole:
  • feel very thirsty
  • feel very hungry
  • feel sick to your stomach
  • need to urinate more than usual
  • feel weak or tired
  • feel confused, or your breath smells fruity
• Increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start brexpiprazole, and then periodically during treatment with brexpiprazole.
• Weight gain. You and your healthcare provider should check your weight before you start and often during treatment with brexpiprazole.

Unusual and uncontrollable (compulsive) urges. Some people taking brexpiprazole have had strong unusual urges, to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having new or unusual strong urges or behaviors, talk to your healthcare provider.

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with brexpiprazole.

Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded, or pass out (faint) when you rise too quickly from a sitting or lying position.

Falls. Brexpiprazole may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Seizures (convulsions). Brexpiprazole may increase your risk of seizures.

Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking brexpiprazole?”

Difficulty swallowing that can cause food or liquid to get into your lungs.

Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. See “What should I avoid while taking brexpiprazole?”

Brexpiprazole may harm an unborn baby.

These are not all the possible side effects of brexpiprazole. Call your doctor for medical advice about side effects.

Before taking

Do not take brexpiprazole if you are allergic to brexpiprazole, Rexulti, or any inactive ingredient in the tablets.

Before taking brexpiprazole, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had heart problems or a stroke
• have or have had low or high blood pressure
• have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar.
• have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver problems
• have or have had a low white blood cell count
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Brexpiprazole may harm your unborn baby. Taking brexpiprazole during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take brexpiprazole during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with brexpiprazole.

There is a pregnancy exposure registry for women who are exposed to brexpiprazole during pregnancy. If you become pregnant during treatment with brexpiprazole, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/.

Breastfeeding

It is not known if brexpiprazole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with brexpiprazole.

How should I take brexpiprazole?

Take brexpiprazole exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose if needed. Do not change the dose or stop taking brexpiprazole without first talking to your healthcare provider.

• Take brexpiprazole 1 time each day.
• Brexpiprazole may be taken with or without food.

Brexpiprazole dosing

The dosage of Brexpiprazole varies depending on the condition being treated and the age of the patient.

The dosage may need to be adjusted for moderate to severe liver disease, kidney disease, and interacting medications.

Note that generic brexpiprazole is only approved for depression and schizophrenia in adults, not for all the uses Rexulti is approved for.

What should I avoid while taking brexpiprazole?

Do not drive a car, operate machinery, or do other dangerous activities until you know how brexpiprazole affects you. Brexpiprazole may make you feel drowsy.

Do not become too hot or dehydrated during treatment with brexpiprazole.

• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water.

What happens if I take too much brexpiprazole?

If you take too much brexpiprazole, call your healthcare provider or Poison Help Line or go to the nearest hospital emergency room right away.

What other drugs affect brexpiprazole?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Brexpiprazole and other medicines may affect each other causing possible serious side effects. Brexpiprazole may affect the way other medicines work, and other medicines may affect how brexpiprazole works. Especially tell your healthcare provider if you take:

• Strong CYP2D6 or CYP3A4 inhibitors, such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, paroxetine, fluoxetine, or bupropion. Administer half the recommended dosage of brexpiprazole
• Strong/moderate CYP2D6 with strong/moderate CYP3A4 inhibitors: Administer one-quarter of the recommended dosage of brexpiprazole
• strong/moderate CYP3A4 inhibitors and you are a known CYP2D6 poor metabolizer: Administer one-quarter of the recommended dosage of brexpiprazole
• Strong CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John’s Wort, or glucocorticoids. Double the recommended dosage of brexpiprazole and further adjust based on the clinical response.

Your healthcare provider can tell you if it is safe to take brexpiprazole with your other medicines. Do not start or stop any medicines during treatment with brexpiprazole without first talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store brexpiprazole tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep out of the reach of children.

Ingredients

Brexpiprazole is available as the brand Rexulti and as generic brexpiprazole.

Active ingredient: brexpiprazole

Inactive ingredients (Rexulti brand): lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, and talc. For color: titanium dioxide, iron oxide, and ferrosoferric oxide.

Inactive ingredients (generic brexpiprazole [Ajanta Pharma USA Inc.]: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose unspecified, low-substituted hydroxypropyl cellulose unspecified, magnesium stearate, Hypromellose unspecified, talc, titanium dioxide, propylene glycol, ferric oxide red

Inactive ingredients (generic brexpiprazole [Amneal Pharmaceuticals NY LLC]: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose unspecified, lactose monohydrate, microcrystalline cellulose, magnesium stearate, corn starch,  talc, titanium dioxide.

Who makes brexpiprazole?

Rexulti (the brand of brexpiprazole) is manufactured through a partnership between two pharmaceutical companies:

• Otsuka Pharmaceutical (Tokyo, Japan)
  • Also makes Abilify, Samsca, and other medications
• Lundbeck (Copenhagen, Denmark)
  • Also makes Lexapro, Vyepti, and other medications.

These companies have a long-standing partnership in developing psychiatric medications, with Rexulti being one of their major joint products.

Generic brexpiprazole is packaged by Ajanta Pharma USA Inc. and Amneal Pharmaceuticals NY LLC.

What is Geodon?

Geodon is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Geodon is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old. It is available as an oral (by mouth) treatment as an injection.

Geodon injection is used to quickly treat agitation in people with schizophrenia.

Warnings

You should not use Geodon if you have a heart rhythm disorder, a history of long QT syndrome, uncontrolled heart failure, if you have recently had a heart attack, or if you are allergic to ziprasidone.

Some medicines can cause unwanted or dangerous effects when used with ziprasidone, and should not be used at the same time. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Stop taking Geodon and call your doctor right away if you have a chest pain, severe dizziness, and a fast or pounding heartbeat. These could be signs of a serious heart rhythm problem.

This medicine is not approved for use in older adults with dementia-related psychosis.

Stop taking Geodon and call your doctor right away if you have severe muscle pains, muscle spasms, fevers, sweating, or confusion.

Stop using this medicine and call your doctor right away if you have a new or worsening skin rash with fever or swollen glands.

Tell your doctor if you experience prolonged diarrhea or loose stools while taking Geodon.

Before taking this medicine

You should not use Geodon if you are allergic to ziprasidone, or if you have:

• a heart rhythm disorder;
• a personal or family history of long QT syndrome;
• uncontrolled or untreated heart failure; or
• if you have recently had a heart attack.

Geodon is not approved for use in psychotic conditions related to dementia. Ziprasidone may increase the risk of death in older adults with dementia-related psychosis.

Geodon should never be taken together with any of the following drugs, or a life-threatening heart rhythm disorder could occur:

• anagrelide;
• methadone;
• tacrolimus;
• certain anti-nausea medicines including dolasetron, droperidol, or ondansetron;
• the antibiotics azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, and pentamidine;
• certain cancer medicines such as arsenic trioxide and vandetanib;
• the antidepressants citalopram, escitalopram;
• anti-malaria medications including chloroquine, halofantrine, mefloquine;
• the following heart rhythm medicines – amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or
• certain anti-psychotics such as chlorpromazine, haloperidol, mesoridazine, pimozide, and thioridazine.

This list is not complete and there may be other drugs that should not be taken at the same time as Geodon. Tell your doctor about all medicines you use.

To make sure Geodon is safe for you, tell your doctor if you have ever had:

• any heart problems;
• a heart attack or stroke;
• a bone marrow or blood cell disorder;
• breast cancer;
• low blood levels of potassium or magnesium;
• diabetes (ziprasidone may raise your blood sugar);
• seizures or epilepsy;
• suicidal thoughts;
• Alzheimer’s disease;
• trouble swallowing;
• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Geodon, do not stop taking it without your doctor’s advice.

It is not known whether ziprasidone passes into breast milk or if it could harm a nursing baby. Talk to your doctor about Geodon if you are planning to breastfeed.

Older adults may be more sensitive to the effects of this medicine.

Geodon is not approved for use by anyone younger than 18 years old.

How should I take Geodon?

Use Geodon exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Geodon capsules are taken by mouth.

Geodon injection is injected into a muscle. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Take this medicine with food. Swallow the capsule whole.

While using Geodon, you may need frequent blood tests to check your kidney or liver function may.

If you are diabetic, check your blood sugar levels on a regular basis while you are taking Geodon.

Use Geodon regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take several weeks before your symptoms improve. Do not stop using this medicine suddenly, even if you feel fine. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, light, and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include cause excessive sleepiness, slurred speech, high blood pressure, shaking, tremors, or anxiety.

While you are taking Geodon, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Geodon may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Geodon side effects

Get emergency medical help if you have signs of an allergic reaction to Geodon: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using ziprasidone.

Also call your doctor at once if you have:

• dizziness or a light-headed feeling, like you might pass out;
• chest pain, fast or pounding heartbeats;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, pain when swallowing;
• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
• very stiff (rigid) muscles, high fever, sweating, confusion, agitation.

Common Geodon side effects may include:

• dizziness, drowsiness, weakness;
• headache;
• nausea, vomiting;
• trouble swallowing;
• weight gain;
• feeling restless or being unable to sit still;
• tremors, involuntary muscle movements;
• vision problems; or
• runny nose, new or worsening cough.

What is Invega?

Invega is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Invega is used to treat schizophrenia in adults and teenagers who are at least 12 years old.

Invega may also be used for purposes not listed in this medication guide.

Warnings

Invega is not for use in psychotic conditions related to dementia. Paliperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related psychosis.

While you are taking Invega, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Stop taking Invega and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, or feeling like you might pass out.

Before taking this medicine

You should not use Invega if you are allergic to paliperidone or risperidone (Risperdal).

Paliperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

High doses or long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you use Invega, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

To make sure Invega is safe for you, tell your doctor if you have ever had:

• heart problems, or a heart attack;
• long QT syndrome (in you or a family member);
• high or low blood pressure, or fainting spells;
• low white blood cell (WBC) counts;
• a serious neurologic disorder caused by taking an antipsychotic medicine;
• uncontrolled muscle movements in your face;
• a stomach or intestinal disorder;
• liver or kidney disease;
• seizures or epilepsy;
• an electrolyte imbalance (such as low potassium or magnesium levels in your blood);
• diabetes (paliperidone may raise your blood sugar); or
• breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop using Invega without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of paliperidone on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take Invega?

Take Invega exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Invega with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your doctor will need to check your progress on a regular basis.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness, fast heartbeats, and fainting.

What to avoid

While you are taking Invega, you may be more sensitive to heat. Avoid getting too hot, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking paliperidone.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Invega side effects

Get emergency medical help if you have signs of an allergic reaction to Invega: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Invega and call your doctor at once if you have any of these signs of a serious movement disorder:

• tremors or shaking in your arms or legs;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
• any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• breast swelling (in women or men), nipple discharge;
• changes in menstrual periods;
• impotence, penis erection that is painful or lasts 4 hours or longer;
• weight gain;
• low white blood cell counts – fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing;
• high blood sugar – increased thirst, increased urination, hunger, fruity breath odor; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, fast or pounding heartbeats, fainting.

Common Invega side effects may include:

• drowsiness;
• anxiety;
• muscle stiffness, tremors or shaking;
• uncontrolled muscle movements, trouble with walking, balance, or speech;
• weight gain;
• upset stomach, constipation;
• fast heart rate; or
• stuffy nose, sore throat.

What is Invega Sustenna?

Invega Sustenna is an extended-release antipsychotic medicine given by intramuscular injection.

Invega Sustenna is prescription medicine used to treat schizophrenia in adults.

Invega Sustenna is also used alone or with other medicines to treat schizoaffective disorder in adults.

When you receive your first dose of Invega Sustenna you will need to get a second dose one week later. After that you will only need to get one injection each month.

Warnings

Invega Sustenna is not approved for use in older adults with dementia-related psychosis.

Dizziness, sleepiness, and feeling less stable may happen with Invega Sustenna. This may lead to falling, which can cause broken bones or other health problems. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.

Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping Invega Sustenna, but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

Before taking this medicine

You should not use Invega Sustenna if you are allergic to Invega Sustenna or to risperidone (Risperdal).

Invega Sustenna may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

High doses or long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you use Invega Sustenna, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Before you receive your first injection, tell your doctor if you have never taken oral (by mouth) Invega Sustenna or risperidone.

To make sure Invega Sustenna is safe for you, tell your doctor if you have ever had:

• heart problems, or a heart attack;
• long QT syndrome (in you or a family member);
• high or low blood pressure, or fainting spells;
• low white blood cell (WBC) counts;
• a serious neurologic disorder caused by taking an antipsychotic medicine;
• uncontrolled muscle movements in your face;
• liver or kidney disease;
• seizures or epilepsy;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• diabetes (paliperidone may raise your blood sugar); or
• breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using Invega Sustenna.

Using antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop using Invega Sustenna without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of paliperidone on the baby.

It may not be safe to breastfeed while using Invega Sustenna. Ask your doctor about any risk.

Invega Sustenna is not approved for use by anyone younger than 18 years old.

How is Invega Sustenna given?

Invega Sustenna is injected into a muscle. A healthcare provider will give you this injection.

Invega Sustenna is usually given only once per month, but the first two doses are given 1 week apart. Invega Trinza is usually given once every 3 months, after you have used Invega Sustenna for at least 4 months in a row.

Follow your doctor’s dosing instructions very carefully. Get your Invega Sustennas regularly to get the most benefit.

Your doctor will need to check your progress while you are using Invega Sustenna.

Dosing information

Usual Adult Dose of Invega Sustenna for Schizophrenia:

1-month extended-release injectable suspension:
-For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.
-Dosing in the US and Canada is the same; however, paliperidone extended-release injectable suspension is dosed as the salt (paliperidone palmitate) in the US and as the base (paliperidone) in Canada:

Paliperidone palmitate:
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later; administer IM into deltoid muscle
-Maintenance dose: 117 mg IM monthly; administer into deltoid or gluteal muscle
-Dose range: 39 to 234 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months
-Maximum dose: 234 mg/month

Paliperidone (base):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later; administer IM into deltoid muscle
-Maintenance dose: 75 mg IM monthly; administer into deltoid or gluteal muscle
-Dose range: 25 to 150 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Comments:
-The dosing window for maintenance doses is 7 days before or after monthly time point.
-If a dose is missed during initial titration or maintenance dosing, see dosage adjustment section for guidance.

Usual Adult Dose od Invega Sustenna for Schizoaffective Disorder:

1-month extended-release injectable suspension::
-For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.
-Dosing in the US and Canada is the same; however, paliperidone extended-release injectable suspension is dosed as the salt (paliperidone palmitate) in the US and as the base (paliperidone) in Canada:

Paliperidone palmitate:
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later; administer IM into deltoid muscle
-Dose range: 78 to 234 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months
-Maximum dose: 234 mg/month

Paliperidone (base):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later; administer IM into deltoid muscle
-Dose range: 50 to 150 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Comments:
-The dosing window for maintenance doses is 7 days before or after monthly time point.
-If a dose is missed during initial titration or maintenance dosing, see dosage adjustment section for guidance.

Use: Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Invega Sustenna.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include a headache with chest pain, fast or pounding heartbeats, and severe dizziness.

What should I avoid while using Invega Sustenna?

Avoid drinking alcohol. Dangerous side effects could occur.

While you are using Invega Sustenna, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Avoid driving or hazardous activity until you know how Invega Sustenna will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Invega Sustenna side effects

Get emergency medical help if you have signs of an allergic reaction to Invega Sustenna: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have any of these signs of a serious movement disorder:

• tremors or shaking in your arms or legs;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
• any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• trouble swallowing;
• a seizure (convulsions);
• breast swelling (in women or men), nipple discharge;
• changes in menstrual periods;
• impotence, or penis erection that is painful or lasts 4 hours or longer;
• weight gain;
• fever, chills, sore throat, mouth sores, feeling light-headed;
• high blood sugar – increased thirst, increased urination, hunger, fruity breath odor; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, fast or pounding heartbeats, fainting.

Common Invega Sustenna side effects may include:

• dizziness, drowsiness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• feeling restless or anxious;
• muscle stiffness, tremors or shaking;
• uncontrolled muscle movements, trouble with walking, balance, or speech;
• abnormal movements of your eyes;
• weight gain;
• upset stomach, constipation;
• fast heart rate; or
• pain or tenderness where the medicine was injected.

What is Latuda?

Latuda is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Latuda is used to treat schizophrenia in adults and teenagers who are at least 13 years old.

Latuda is also used to treat episodes of depression associated with bipolar disorder (bipolar depression) in adults and children who are at least 10 years old.

Warnings

Latuda is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related psychosis.

Some young people have thoughts about suicide when taking Latuda. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before you take Latuda, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, heart rhythm problems, a history of heart attack or stroke, high cholesterol or triglycerides, low white blood cell (WBC) counts, seizures, diabetes, Parkinson’s disease, trouble swallowing, or a history of breast cancer or suicidal thoughts.

Some medicines can interact with lurasidone and should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

While you are taking Latuda, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Latuda may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of lurasidone. Stop using this medicine and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or pounding heartbeats, feeling like you might pass out, tremors, or twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Before taking this medicine

You should not use Latuda if you are allergic to lurasidone.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lurasidone. Your doctor may change your treatment plan if you also use:

• antifungal medicine such as ketoconazole or voriconazole;
• an antibiotic such as clarithromycin or rifampin;
• an antiviral such as ritonavir;
• St. John’s wort; or
• seizure medicine such as carbamazepine or phenytoin.

Latuda is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related conditions.

Tell your doctor if you have ever had:

• heart disease or a stroke;
• high or low blood pressure;
• high cholesterol or triglycerides (a type of fat in the blood);
• diabetes or high blood sugar (in you or your family);
• a seizure;
• liver or kidney disease;
• low white blood cell (WBC) counts;
• abnormal hormone function tests (thyroid, pituitary gland);
• breast cancer; or
• suicidal thoughts or actions.

Some people have thoughts about suicide while taking lurasidone. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking lurasidone without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lurasidone on the baby.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

Latuda is not approved for schizophrenia in anyone younger than 13 years old. Latuda is not approved for depression in anyone younger than 10 years old.

How should I take Latuda?

Take Latuda exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Latuda should be taken with food (at least 350 calories).

You may need frequent blood tests.

It may take several weeks before your symptoms improve. Keep using the medication as directed. Call your doctor if your symptoms do not improve, or if they get worse while using Latuda.

You should not stop using this medicine suddenly. Stopping suddenly may cause other problems.

It is easier to become dangerously overheated and dehydrated while you are taking Latuda. Drink plenty of fluids, especially in hot weather and during exercise. You may also be more sensitive to temperature extremes (hot or cold).

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Grapefruit and grapefruit juice may interact with lurasidone and lead to unwanted side effects. Avoid the use of grapefruit products while taking Latuda.

Latuda side effects

Get emergency medical help if you have signs of an allergic reaction to Latuda: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of Latuda can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you use lurasidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

• any new or unusual muscle movements you cannot control;
• a light-headed feeling, like you might pass out;
• a seizure (convulsions);
• (in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;
• (in men) breast swelling, impotence;
• trouble swallowing;
• manic episodes – racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• low white blood cell counts – fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing;
• high blood sugar – increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Latuda side effects may include:

• drowsiness;
• weight gain;
• tremors, muscle stiffness, slow muscle movement;
• feeling restless or being unable to sit still;
• nausea, vomiting;
• runny nose; or
• sleep problems (insomnia).

What is lurasidone?

Lurasidone is an antipsychotic medicine that is used to treat schizophrenia in adults and teenagers who are at least 13 years old.

Lurasidone is also used to treat episodes of depression related to bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Lurasidone may also be used for purposes not listed in this medication guide.

Lurasidone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of lurasidone can cause a serious movement disorder that may not be reversible. The longer you use lurasidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Lurasidone may cause serious side effects. Call your doctor at once if you have:

• any new or unusual muscle movements you cannot control;
• a light-headed feeling, like you might pass out;
• a seizure (convulsions);
• (in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;
• (in men) breast swelling, impotence;
• trouble swallowing;
• manic episodes–racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• low white blood cell counts–fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing;
• high blood sugar–increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of lurasidone may include:

• drowsiness;
• weight gain;
• tremors, muscle stiffness, slow muscle movement;
• feeling restless or being unable to sit still;
• nausea, vomiting;
• runny nose; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

Warnings

Lurasidone is not approved for use in older adults with dementia-related psychosis.

Some people have thoughts about suicide while taking lurasidone. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Before taking this medicine

You should not use lurasidone if you are allergic to it.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lurasidone. Your doctor may change your treatment plan if you also use:

• antifungal medicine such as ketoconazole or voriconazole;
• an antibiotic such as clarithromycin or rifampin;
• an antiviral such as ritonavir;
• St. John’s wort; or
• seizure medicine such as carbamazepine or phenytoin.

Lurasidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart disease or a stroke;
• high or low blood pressure;
• high cholesterol or triglycerides (a type of fat in the blood);
• diabetes or high blood sugar (in you or your family);
• a seizure;
• liver or kidney disease;
• low white blood cell (WBC) counts;
• abnormal hormone function tests (thyroid, pituitary gland);
• breast cancer; or
• suicidal thoughts or actions.

Some people have thoughts about suicide while taking lurasidone. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking lurasidone without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lurasidone on the baby.

It may not be safe to breastfeed a baby while you are using lurasidone. Ask your doctor about any risks.

Lurasidone is not approved for schizophrenia in anyone younger than 13 years old. Lurasidone is not approved for depression in anyone younger than 10 years old.

How should I take lurasidone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Lurasidone should be taken with food (at least 350 calories).

You may need frequent blood tests.

It may take several weeks before your symptoms improve. Keep using the medication as directed. Call your doctor if your symptoms do not improve, or if they get worse while using lurasidone.

You should not stop using lurasidone suddenly. Stopping suddenly may cause other problems.

It is easier to become dangerously overheated and dehydrated while you are taking lurasidone. Drink plenty of fluids, especially in hot weather and during exercise. You may also be more sensitive to temperature extremes (hot or cold).

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line

What should I avoid while taking lurasidone?

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how lurasidone will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Grapefruit and grapefruit juice may interact with lurasidone and lead to unwanted side effects. Avoid the use of grapefruit products while taking lurasidone.

What is olanzapine?

Olanzapine (brand name Zyprexa) is an atypical antipsychotic that may be used to treat adults and adolescents aged 13 and older with schizophrenia or bipolar I disorder. For bipolar I disorder, it may be used:

• alone for manic or mixed episodes, or in combination with lithium or valproate
• with fluoxetine for depressive episodes in people aged 10 and older.

For treatment-resistant depression, olanzapine is used in combination with fluoxetine (Symbyax).

Olanzapine is available as oral tablets, orally disintegrating tablets, or an injection that is given into a muscle (intramuscular [IM]). The olanzapine IM preparation is only for acute agitation associated with schizophrenia and bipolar I mania in adults.

Olanzapine may work by blocking certain receptors in the brain, notably dopamine and serotonin, although the exact way it works in schizophrenia and bipolar I disorder is unknown.

Olanzapine was FDA approved on September 30, 1996, under the brand name Zyprexa. Generic olanzapine is available.

Olanzapine side effects

Olanzapine may cause serious side effects such as an increased risk of death or stroke in elderly patients with dementia, a higher risk of suicide when taken with fluoxetine, metabolic changes, tardive dyskinesia, low blood pressure, and blood cell disorders. See the warnings below for a full list of serious side effects.

Common side effects of olanzapine that affect 5% or more people who take it include postural hypotension (a drop in blood pressure when going from a lying or sitting position to standing)

• Constipation
• Weight gain and increased appetite
• Dizziness
• Personality disorder
• Restlessness
• Sedation
• Headache
• Abdominal pain
• Pain in the extremities
• Tiredness or lack of energy
• Dry mouth
• Tremor.

Other side effects may include increased salivation, speech disorder, forgetfulness, and the feeling of pins and needles in your limbs.

Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness when compared with adults.

Serious side effects and warnings

Olanzapine carries a Boxed warning for an increased risk of death in elderly patients with dementia-related psychosis.

An increased risk of death, strokes, or “mini-strokes” called transient ischemic attacks (TIAs) have been reported in elderly people taking olanzapine who are confused, have memory loss, or have lost touch with reality (dementia-related psychosis). These people should not be given olanzapine.

Olanzapine may cause the following serious side effects.

A higher risk of suicide when olanzapine is used in combination with fluoxetine for people with depression.

High blood sugar (hyperglycemia). This can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to a build-up of acid in your blood due to ketones (ketoacidosis), coma, and death. Your doctor should do tests to check your blood sugar before you start taking olanzapine and during treatment. Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking olanzapine:

• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused or your breath smells fruity.

High-fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers aged 13 to 17 or when used in combination with fluoxetine in children aged 10 to 17. Your healthcare provider should do blood tests to check your cholesterol and triglyceride levels before you start taking olanzapine and during treatment.

Weight gain. This is very common in people who take olanzapine, especially in teenagers aged 13 to 17, or when used in combination with fluoxetine in children aged 10 to 17. Some people gain a lot of weight. You and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

Neuroleptic Malignant Syndrome (NMS). This is a rare but serious side effect of antipsychotics, such as olanzapine that may be fatal. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have symptoms such as high fever, excessive sweating, rigid muscles, confusion, changes in your breathing, heartbeat, and blood pressure.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). This is a serious drug hypersensitivity syndrome with symptoms such as an extensive rash, fever, swollen lymph nodes, liver inflammation, and blood abnormalities. Tell your doctor immediately if you experience any of these signs.

Tardive Dyskinesia.This condition causes persistent body movements that usually affect the face and tongue which you cannot control. It may not go away even if you stop taking olanzapine and may start after you stop taking olanzapine. Tell your doctor if you get any body movements that you cannot control.

Decreased blood pressure when you go from a lying or sitting position to standing. Symptoms may include dizziness, fast or slow heartbeat, or fainting.

Difficulty swallowing, which may cause food or liquid to get stuck in your lungs

Seizures. Tell your doctor if you have had a seizure before or if you have one during treatment with olanzapine

Changes in your blood cells. Your doctor will monitor your blood cell counts especially if you have a history of significantly low white blood cell counts or drug-induced leukopenia or neutropenia

Problems with control of body temperature. You could become very hot, for instance when you exercise a lot or live or holiday in a very hot area. You need to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, or not able to produce enough urine.

May cause drowsiness and impair judgment, thinking, and motor skills. Use with caution when driving or operating machinery until you know how olanzapine affects you.

Olanzapine has not been approved for use in:

• children under 13 years of age when used to treat schizophrenia or bipolar I disorder
• children under 10 years of age when used in combination with fluoxetine for depressive episodes.

Tell your doctor about any side effect that bothers you or does not go away. These are not all the possible side effects of olanzapine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

Olanzapine cost

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of olanzapine.

Before taking

Olanzapine may not be right for you. Before starting, tell your doctor if you have or had:

• heart problems
• seizures
• diabetes or high blood sugar levels (hyperglycemia)
• high cholesterol or triglyceride levels in your blood
• liver problems
• low or high blood pressure
• strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
• Alzheimer’s disease
• narrow-angle glaucoma
• enlarged prostate in men
• bowel obstruction
• phenylketonuria, because some olanzapine disintegrating tablets may contain phenylalanine.
• breast cancer
• thoughts of suicide or hurting yourself
• any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Tell your doctor if you exercise a lot or live or holiday in hot places.

Pregnancy

Taking antipsychotic medication, such as olanzapine, in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away but do not stop taking olanzapine without your doctor’s advice.

Talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/

Breastfeeding

Olanzapine passes into your breast milk. If you are breastfeeding, tell your doctor if you notice severe drowsiness, irritability, feeding problems, tremors, or unusual muscle movements in the nursing baby. Talk to your doctor about the best way to feed your baby if you take olanzapine.

How should I take olanzapine?

Take olanzapine exactly as prescribed. Your doctor may need to change (adjust) the dosage of olanzapine until it is right for you.

• Olanzapine is usually taken once a day.
• Olanzapine can be taken with or without food.

The usual starting dosage of olanzapine for adults with:

• Schizophrenia is olanzapine 5 mg to 10 mg once a day.
• Bipolar I disorder is olanzapine 10 mg to 15 mg once a day.

Olanzapine disintegrating tablets

Olanzapine disintegrating tablets dissolve in your mouth without water.

• Before taking it, make sure that your hands are dry.
• Open the sachet and peel back the foil on the blister. Do not push the tablet through the foil.
• When you open the blister, remove the tablet and put it into your mouth.
• The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.

Olanzapine IM injection

Olanzapine IM is a short-acting formulation that may be given to adults with schizophrenia or bipolar I mania if they have become agitated.

• The usual dosage of olanzapine IM is 10 mg as a single dose.
  • Smaller dosages (5 mg or 7.5 mg) can be given if these are more appropriate.
• A maximum of 3 doses may be given if needed, 2 to 4 hours apart.
• Your doctor will monitor you for low blood pressure on standing (orthostatic hypotension) before giving you another dose. Tell your doctor if you feel faint or dizzy when you stand up.

Olanzapine: other information

You may need regular medical tests while taking olanzapine to check your cholesterol levels.

If you are diabetic, check your blood sugar levels regularly, because olanzapine can cause high blood sugar levels, even in people who are not diabetic.

Olanzapine may cause you to gain weight more easily. Be conscious of your weight and what you eat. Exercise regularly. Talk to your healthcare provider if you are putting on too much weight.

Call your healthcare provider if you do not think you are getting better or have any concerns about your condition while taking olanzapine.

• The symptoms of bipolar I disorder, treatment-resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.

What should I avoid while taking olanzapine?

Olanzapine can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how it affects you.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid getting up too fast from sitting or lying down, or you may feel dizzy.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking olanzapine.

Avoid stopping olanzapine suddenly. You should never stop taking it without your doctor’s advice. When it comes time to stop olanzapine, it should be withdrawn slowly over several weeks under a doctor’s supervision. One survey reported at least 72% of people taking antipsychotics such as olanzapine experienced withdrawal symptoms.

Olanzapine withdrawal

Common symptoms of olanzapine withdrawal include nausea, headaches, dizziness, sleep disturbances, brain zaps, and psychological symptoms, such as anxiety, irritability, mood swings, and difficulty concentrating.

• Nearly half of people describe these symptoms as severe, especially during the early stage of withdrawal.
• The length of time withdrawal symptoms from olanzapine last varies; some report symptoms last two weeks or less, while others experience symptoms for years. This appears to correlate with the length of time people have taken the medication.
• If you want to stop taking olanzapine, talk to your healthcare provider about the best way to come off it. This may involve slowly reducing your dose, switching to another medication that might be easier to withdraw from, or taking other medications to help with your withdrawal symptoms.

What happens if I miss a dose?

If you miss a dose of olanzapine, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.

What happens if I overdose?

If you take too much olanzapine, call your doctor or poison control center right away, or get emergency treatment.

Overdose symptoms may include drowsiness, agitation, aggression, slurred speech, confusion, increased heart rate, jerky or uncontrolled muscle movements, trouble breathing, or fainting.

What other drugs will affect olanzapine?

Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Olanzapine and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take olanzapine with your other medicines. Do not start or stop any medicine while taking olanzapine without talking to your doctor first. Especially tell your doctor if you take:

• Diazepam, lorazepam, or other benzodiazepines. This may make some side effects such as orthostatic hypotension worse
• Carbamazepine. May reduce the effect of olanzapine.
• Fluvoxamine. May increase levels of olanzapine and make side effects worse
• Fluoxetine. This may increase the risk of suicidal thoughts and behaviors
• Other medications that affect the brain, such as sedatives or sedating antihistamines. These can make side effects worse, especially when combined with alcohol
• Heart medications that lower blood pressure. Olanzapine may cause an enhanced effect
• Levodopa and dopamine Agonists. Olanzapine may counteract the effects of these drugs.

Anticholinergics (antimuscarinics), such as benztropine. Use with caution in patients with urinary retention, prostatic conditions, constipation, and some other conditions

Alcohol may also make side effects such as sleepiness and orthostatic hypotension worse.

Taking olanzapine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

This is not a complete list of interactions. Talk to your healthcare provider or pharmacist for a full list of interactions.

Storage

Store olanzapine at room temperature, between 68°F to 77°F (20°C to 25°C), away from light. Keep it dry and away from moisture.

Keep out of the reach of children.

Olanzapine ingredients

Active: olanzapine.

Inactive: Depends on the manufacturer. Various generic manufacturers make olanzapine, such as Apotex Inc., Dr Reddys Labs Ltd, and Zydus Pharms. Eli Lilly and Company makes the brand of olanzapine called Zyprexa.

Olanzapine tablets (brand Zyprexa)

Active ingredient: olanzapine.

Inactive ingredients: carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients.

Color coating: Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, or Synthetic Red Iron Oxide.

Olanzapine is available as olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg tablets. Tablets are not scored.

Olanzapine disintegrating tablets ingredients (brand Zyprexa Zydis)

Active ingredient: olanzapine.

Inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propylparaben.

Olanzapine Zydis orally disintegrating tablets are available as olanzapine 5 mg, 10 mg, 15 mg, and 20 mg tablets. Tablets are not scored.

Olanzapine IM injection ingredients (brand Zyprexa)

Active ingredient: olanzapine.

Inactive ingredients: lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide.

Olanzapine injection is available as an olanzapine 10 mg vial.

Who makes olanzapine?

Various generic manufacturers make olanzapine, such as Apotex Inc., Dr Reddys Labs Ltd, and Zydus Pharms.

Eli Lilly and Company makes the brand of olanzapine called Zyprexa.

What is quetiapine?

Quetiapine is used to treat schizophrenia in adults and children who are at least 13 years old. It is also used alone or with with divalproex or lithium to treat episodes of mania (frenzied, abnormally excited or irritated mood) or depression in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods).

In addition, quetiapine is used with other medications to prevent episodes of depression in patients with bipolar disorder.

Quetiapine extended release is also used alone to treat manic episodes in children at least 10 years old with bipolar disorder.

Quetiapine extended release is used in combination with antidepressant medications to treat major depressive disorder in adults.

Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers.

Quetiapine belongs to class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Quetiapine side effects

Get emergency medical help if you have signs of an allergic reaction to quetiapine: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of quetiapine can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Quetiapine may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• breast swelling and tenderness, nipple discharge, impotence, missed menstrual periods;
• trouble swallowing, severe constipation;
• painful or difficult urination;
• high blood pressure, fast, slow or uneven heart rate;
• a light-headed feeling, sudden numbness or weakness, severe headache;
• blurred vision, eye pain or redness, seeing halos around lights;
• a seizure, feeling unusually hot or cold;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• underactive thyroid – tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough.

Common quetiapine side effects may include:

• speech problems;
• dizziness, drowsiness, tiredness;
• feeling like you might pass out;
• lack of energy;
• fast heartbeats;
• increased appetite, weight gain;
• upset stomach, vomiting, constipation;
• stomach pain, nausea;
• abnormal liver function tests, sore throat;
• stuffy nose, dry mouth; or
• difficulty moving.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use quetiapine if you are allergic to it.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

To make sure quetiapine is safe for you, tell your doctor if you have ever had:

• a nervous system reaction associated with antipsychotic medication use;
• heart disease, a heart attack or stroke;
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• high or low blood pressure;
• low white blood cell (WBC) counts;
• abnormal thyroid tests or prolactin levels;
• an enlarged prostate, constipation or urination problems;
• a seizure;
• glaucoma or cataracts;
• diabetes (in you or a family member);
• high cholesterol or triglycerides; or
• liver disease.

Quetiapine may increase the risk of death in older adults with mental health problems related to dementia.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

It may be harder for you to get pregnant while you are using quetiapine.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of quetiapine on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take quetiapine?

Take quetiapine as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take quetiapine with or without food, but take it the same way each time.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood may need to be checked on a regular basis, and you may need other medical tests.

Your blood pressure may need to be checked often.

Do not stop using quetiapine suddenly, your condition may get worse, or you could have unpleasant symptoms (such as trouble sleeping, nausea and vomiting). Ask your doctor before stopping the medicine.

This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you use quetiapine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking quetiapine?

Do not drink alcohol. Dangerous side effects could occur.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how quetiapine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are taking quetiapine.

Warnings

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting quetiapine. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

What is Rexulti?

Rexulti is an antipsychotic used to treat major depressive disorder, schizophrenia, or agitation associated with dementia due to Alzheimer’s disease. It is an oral tablet that is taken once a day.

Rexulti’s mechanism of action involves adjusting the imbalance of natural chemicals in the brain (also called neurotransmitters), such as dopamine and serotonin. These neurotransmitters help cells to send messages to each other. An imbalance of these natural chemicals is thought to be associated with several psychiatric conditions, including schizophrenia, depression, and agitation associated with dementia due to Alzheimer’s disease .

Rexulti (brexpiprazole) first gained FDA approval on July 10, 2015. Rexulti belongs to the drug class called atypical antipsychotics.

Rexulti is available as a generic under the name brexpiprazole. The brexpiprazole generic is only approved for depression and schizophrenia in adults, whereas the brand Rexulti is also approved for adolescents aged 13 and older with schizophrenia and for dementia-related agitation in Alzheimer’s disease.

Rexulti uses

Rexulti is an atypical antipsychotic used:

• along with antidepressant medicines to treat major depressive disorder (MDD) in adults
• to treat schizophrenia in adults and children aged 13 years and older
• to treat agitation that may happen with dementia due to Alzheimer’s disease.

Rexulti should not be used as an “as-needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

It is not known if Rexulti is safe and effective for the treatment of MDD in children or the treatment of schizophrenia in children under 13 years of age.

Rexulti side effects

The most common side effects of Rexulti are:

• weight gain
• sleepiness
• dizziness
• common cold symptoms
• restlessness or feeling like you need to move (akathisia).

Serious side effects and warnings

Rexulti carries a Boxed Warning for an increased risk of death in elderly patients with dementia-related psychosis.

Increased risk of death in elderly people with dementia-related psychosis. Medicines like Rexulti can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Rexulti is not approved for dementia-related psychosis without agitation that may happen with Alzheimer’s disease.

Increased risk of suicidal thoughts and actions. Rexulti and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

• Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when Rexulti or the antidepressant medicine is started or when the dose is changed.
• Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
• Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worsening depression
• new or worsening anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worsening irritability
• acting aggressively, being angry, or being violent
• acting on dangerous impulses
• an extreme increase in activity or talking (mania)
• other unusual changes in behavior or mood.

Other serious side effects of Rexulti include the following.

Cerebrovascular problems (these involve the blood vessels of the brain), including stroke, in elderly people with dementia-related psychosis, that can lead to death.

Neuroleptic malignant syndrome (NMS), a rare and life-threatening reaction to antipsychotic drugs. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

• high fever
• stiff muscles
• confusion
• changes in your pulse, blood pressure, heart rate, and breathing
• increased sweating.

Uncontrolled body movements (tardive dyskinesia). Rexulti may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Rexulti. Tardive dyskinesia may also start after you stop taking Rexulti.

Rexulti may also cause problems with your metabolism such as:

• High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Rexulti. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start Rexulti and then regularly during long-term treatment with Rexulti. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Rexulti:
  • feel very thirsty
  • feel very hungry
  • feel sick to your stomach
  • need to urinate more than usual
  • feel weak or tired
  • feel confused, or your breath smells fruity
• Increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start Rexulti, and then periodically during treatment with Rexulti.
• Weight gain. You and your healthcare provider should check your weight before you start and often during treatment with Rexulti.

Unusual and uncontrollable (compulsive) urges. Some people taking Rexulti have had strong, unusual urges to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having new or unusually strong urges or behaviors, talk to your healthcare provider.

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with Rexulti.

Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded, or pass out (faint) when you rise too quickly from a sitting or lying position.

Falls. Rexulti may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills, which may lead to falls that can cause fractures or other injuries.

Seizures (convulsions). Rexulti may increase your risk of seizures.

Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking Rexulti?”

Difficulty swallowing that can cause food or liquid to get into your lungs.

Sleepiness, drowsiness, feeling tired, difficulty thinking, and doing normal activities. See “What should I avoid while taking Rexulti?”

Rexulti may harm an unborn baby.

These are not all the possible side effects of Rexulti. Call your doctor for medical advice about side effects.

Before taking

Do not take Rexulti if you are allergic to Rexulti, Rexulti, or any inactive ingredient in the tablets.

Before taking Rexulti, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had heart problems or a stroke
• have or have had low or high blood pressure
• have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar.
• have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver problems
• have or have had a low white blood cell count
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Rexulti may harm your unborn baby. Taking Rexulti during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take Rexulti during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Rexulti.

There is a pregnancy exposure registry for women who are exposed to Rexulti during pregnancy. If you become pregnant during treatment with Rexulti, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/.

Breastfeeding

It is not known if Rexulti passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Rexulti.

How should I take Rexulti?

Take Rexulti exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose if needed. Do not change the dose or stop taking Rexulti without first talking to your healthcare provider.

• Take Rexulti 1 time each day.
• Rexulti may be taken with or without food.

Dosing information

The dosage of Rexulti varies depending on the condition being treated and the age of the patient.

The dosage may need to be adjusted for moderate to severe liver disease, kidney disease, and interacting medications.

Dose of Rexulti for Major Depressive Disorder (Adults)

• Starting dose: 0.5 to 1 mg daily
• Target dose: 2 mg daily
• Maximum dose: 3 mg daily

Dose of Rexulti for Schizophrenia (Adults)

• Starting dose: 1 mg daily
• Target dose: 2 to 4 mg daily
• Maximum dose: 4 mg daily

Dose of Rexulti for Schizophrenia (Children 13 to 17 years)

• Starting dose: 0.5 mg daily
• Target dose: 2 to 4 mg daily
• Maximum dose: 4 mg daily

Dose of Rexulti for Agitation Associated With Dementia

• Starting dose: 0.5 mg daily
• Target dose: 2 mg daily
• Maximum dose: 3 mg daily

What should I avoid while taking Rexulti?

Do not drive a car, operate machinery, or do other dangerous activities until you know how Rexulti affects you. Rexulti may make you feel drowsy.

Do not become too hot or dehydrated during treatment with Rexulti.

• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water.

What happens if I take too much Rexulti?

If you take too much Rexulti, call your healthcare provider or Poison Help Line or go to the nearest hospital emergency room right away.

What other drugs affect Rexulti?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rexulti and other medicines may affect each other causing possible serious side effects. Rexulti may affect the way other medicines work, and other medicines may affect how Rexulti works. Especially tell your healthcare provider if you take:

• Strong CYP2D6 or CYP3A4 inhibitors, such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, paroxetine, fluoxetine, or bupropion. Administer half the recommended dosage of Rexulti
• Strong/moderate CYP2D6 with strong/moderate CYP3A4 inhibitors: Administer one-quarter of the recommended dosage of Rexulti
• strong/moderate CYP3A4 inhibitors, and you are a known CYP2D6 poor metabolizer: Administer one-quarter of the recommended dosage of Rexulti
• Strong CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John’s Wort, or glucocorticoids. Double the recommended dosage of Rexulti and further adjust based on the clinical response.

Your healthcare provider can tell you if it is safe to take Rexulti with your other medicines. Do not start or stop any medicines during treatment with Rexulti without first talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What is Risperdal?

Risperdal is an antipsychotic medicine that works by changing the effects of chemicals in the brain.

Risperdal is used to treat schizophrenia in adults and children who are at least 13 years old.

Risperdal is also used to treat symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Risperdal is also used to treat symptoms of irritability in autistic children who are 5 to 16 years old.

Warnings

Risperdal is not approved for use in older adults with dementia-related psychosis.

Do not give Risperdal to a child without a doctor’s advice.

While you are taking this medicine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medication.

Risperidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of risperidone.

Stop using Risperdal and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

Before taking this medicine

You should not use Risperdal if you are allergic to risperidone.

Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, heart rhythm problems, stroke or heart attack;
• diabetes (or risk factors such as obesity or family history of diabetes);
• low white blood cell (WBC) counts;
• liver or kidney disease;
• seizures;
• breast cancer;
• low bone mineral density;
• trouble swallowing;
• Parkinson’s disease; or
• if you are dehydrated.

The Risperdal M-Tab orally disintegrating tablet may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking , do not stop taking it without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

Risperidone may temporarily affect fertility (ability to have children) in women.

Risperidone can pass into breast milk and may cause side effects in the baby. If you breast-feed while using Risperdal, tell your doctor if the baby has symptoms such as drowsiness, tremors, or involuntary muscle movements.

Do not give this medicine to a child without a doctor’s advice.

How should I take Risperdal?

Take Risperdal exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Risperdal can be taken with or without food.

Remove the Risperdal M-Tab orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not mix the Risperdal liquid with cola or tea.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, heat, and light. Do not liquid medicine to freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.

What to avoid

Avoid driving or hazardous activity until you know how risperidone will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While you are taking risperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Risperdal side effects

Get emergency medical help if you have signs of an allergic reaction to Risperdal: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• breast swelling or tenderness (in men or women), nipple discharge, impotence, lack of interest in sex, missed menstrual periods;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low white blood cells – sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
• low levels of platelets in your blood – easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• penis erection that is painful or lasts 4 hours or longer.

Common Risperdal side effects may include:

• headache;
• dizziness, drowsiness, feeling tired;
• tremors, twitching or uncontrollable muscle movements;
• agitation, anxiety, restless feeling;
• depressed mood;
• dry mouth, upset stomach, diarrhea, constipation;
• weight gain; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

What is risperidone?

Risperidone is an antipsychotic medicine that works by changing the effects of chemicals in the brain.

Risperidone is used to treat schizophrenia in adults and children who are at least 13 years old.

Risperidone is also used to treat symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Risperidone is also used to treat symptoms of irritability in autistic children who are 5 to 16 years old.

Warnings

Risperidone is not approved for use in older adults with dementia-related psychosis.

Do not give risperidone to a child without a doctor’s advice.

While you are taking this medicine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medication.

Risperidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of this medicine.

Stop using this medicine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

Before taking this medicine

You should not use risperidone if you are allergic to it.

Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, heart rhythm problems, stroke or heart attack;
• diabetes (or risk factors such as obesity or family history of diabetes);
• low white blood cell (WBC) counts;
• liver or kidney disease;
• seizures;
• breast cancer;
• low bone mineral density;
• trouble swallowing;
• Parkinson’s disease; or
• if you are dehydrated.

The risperidone orally disintegrating tablet may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking risperidone, do not stop taking it without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risperidone on the baby.

This medicine may temporarily affect fertility (ability to have children) in women.

Risperidone can pass into breast milk and may cause side effects in the baby. If you breast-feed while using this medicine, tell your doctor if the baby has symptoms such as drowsiness, tremors, or involuntary muscle movements.

Do not give this medicine to a child without a doctor’s advice.

How should I take risperidone?

Take risperidone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Risperidone can be taken with or without food.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not mix the liquid medicine with cola or tea.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, heat, and light. Do not liquid medicine to freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.

What to avoid

Avoid driving or hazardous activity until you know how risperidone will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While you are taking risperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Risperidone side effects

Get emergency medical help if you have signs of an allergic reaction to risperidone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• breast swelling or tenderness (in men or women), nipple discharge, impotence, lack of interest in sex, missed menstrual periods;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low white blood cells – sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
• low levels of platelets in your blood – easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• penis erection that is painful or lasts 4 hours or longer.

Common risperidone side effects may include:

• headache;
• dizziness, drowsiness, feeling tired;
• tremors, twitching or uncontrollable muscle movements;
• agitation, anxiety, restless feeling;
• depressed mood;
• dry mouth, upset stomach, diarrhea, constipation;
• weight gain; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

Oral route(Tablet;Tablet, Disintegrating;Solution)

Warning: Increased Mortality In Elderly Patients With Dementia-Related Psychosis And Suicidal Thoughts And Behaviors With Antidepressant Drugs

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis .Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies . These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older .Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors . Advise families and caregivers of the need for close observation and communication with the prescriber .The safety and efficacy of aripiprazole have not been established in pediatric patients .

Uses for Abilify Discmelt

Aripiprazole is used alone or together with other medicines to treat mental conditions such as bipolar I disorder (manic-depressive illness), major depressive disorder, and schizophrenia. It is also used in children to treat irritability associated with autistic disorder and Tourette syndrome. Aripiprazole works in the brain to change how certain chemicals affect patients. It is an antipsychotic agent.

This medicine is available only with your doctor’s prescription. Abilify® oral solution was withdrawn from the market on May 15, 2015 and this dose form is not marketed by any generic manufacturers.

Before using Abilify Discmelt

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children younger than 13 years of age with schizophrenia and in children younger than 10 years of age with bipolar disorder. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Abilify Mycite® in children. Safety and efficacy have not been established.

Aripiprazole is not approved for use in children or teenagers with major depression.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children 6 to 17 years of age with autistic disorder.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abiraterone Acetate
• Adagrasib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bentazepam
• Benzhydrocodone
• Boceprevir
• Bromazepam
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Ceritinib
• Cetirizine
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clorazepate
• Clothiapine
• Cloxazolam
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delorazepam
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Diazepam
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Josamycin
• Ketamine
• Ketazolam
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levorphanol
• Lofexidine
• Lonafarnib
• Lopinavir
• Loprazolam
• Lorazepam
• Lormetazepam
• Loxapine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Mavacamten
• Medazepam
• Mefloquine
• Meperidine
• Metaclazepam
• Methadone
• Metronidazole
• Mibefradil
• Midazolam
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nitrazepam
• Nordazepam
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pinazepam
• Pipamperone
• Pitolisant
• Ponesimod
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Ribociclib
• Rifampin
• Rifapentine
• Rilpivirine
• Risperidone
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John’s Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Terbinafine
• Tetrabenazine
• Tetrazepam
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trimipramine
• Triptorelin
• Troleandomycin
• Tucatinib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zolpidem
• Zuclopenthixol
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Depression or
• Diabetes, or family history of or
• Drug abuse or dependence, history of or
• Hyperglycemia (high blood sugar) or
• Neuroleptic malignant syndrome (NMS), history of or
• Neutropenia (low white blood cells) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Blood vessel disease or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (decrease in blood volume) or
• Ischemic heart disease, history of or
• Trouble with swallowing—Use with caution. May cause side effects to become worse.
• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper use of Abilify Discmelt

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Swallow the tablets whole. Do not break, crush, or chew them.

Abilify Mycite® has a sensor in the tablet, which helps track it inside the stomach or bowels. The Abilify Mycite® System comes with a patch (wearable sensor), a smartphone application (app), and a web-based portal. Follow your doctor’s instructions on how to use the medicine.

The Abilify Mycite® tablet is usually detected within 30 minutes after you take it, but there may be a delay of more than 2 hours for the smartphone app and web portal to detect that you have taken the medicine, and sometimes it might not be detected at all.

To apply the Abilify Mycite® patch:

• The app will tell you when to apply or remove the patch. It should be changed weekly or sooner as needed.
• Place the patch to the left side of your body just above the lower edge of your rib cage. Do not put the patch in areas where the skin is scraped, cracked, inflamed, or irritated, or near the area where you had removed the previous patch. The app will help you place the patch in the correct location.
• You may keep the patch on when showering, swimming, or exercising.

Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor’s instructions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets and orally disintegrating tablets):
  • For bipolar mania:
    • Abilify® and Abilify Discmelt®:
      • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    • Abilify Mycite®:
      • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For depression:
    • Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For irritability in children with autistic disorder:
    • Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For schizophrenia:
    • Abilify® and Abilify Discmelt®:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • Abilify Mycite®:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For Tourette’s disorder:
    • Children 6 to 18 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If the Abilify Mycite® tablet is not detected on the app or portal after you take it, do not repeat the dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Abilify Discmelt

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may increase the amount of sugar in your blood. Also, the oral liquid form contains sugar. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Do not change the dose or stop taking this medicine without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Side Effects of Abilify Discmelt

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Difficulty with speaking
• drooling
• loss of balance control
• muscle trembling, jerking, or stiffness
• restlessness
• shuffling walk
• stiffness of the limbs
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

Less common

• Blurred vision
• dizziness
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sticking out the tongue
• trouble with breathing or swallowing
• unusual facial expressions

Rare

• High fever
• high or low blood pressure
• increased sweating
• lip smacking or puckering
• loss of bladder control
• muscle spasm or jerking of all extremities
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• seizures
• severe muscle stiffness
• sudden loss of consciousness
• tiredness
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• unusually pale skin

Incidence not known

• Hives or welts, itching, or skin rash
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bigger, dilated, or enlarged pupils (black part of the eye)
• diarrhea
• fast, pounding, or irregular heartbeat or pulse
• increased sensitivity of the eyes to light
• lack or loss of strength
• nausea
• sleepiness or unusual drowsiness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Anxiety
• belching
• blurred vision
• difficulty having a bowel movement
• dry mouth
• fear
• fever
• heartburn
• hyperventilation
• inability to sit still
• indigestion
• irritability
• lightheadedness
• need to keep moving
• nervousness
• rash
• runny nose
• shaking
• sore throat
• stomach discomfort, upset, or pain
• trouble sleeping
• weight gain

Less common

• Accidental injury
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• congestion
• coughing
• difficulty with moving
• dryness or soreness of the throat
• hoarseness
• increased appetite
• increased salivation
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• rapid weight gain
• sneezing
• stuffy nose
• swollen joints
• tender, swollen glands in the neck
• tingling of the hands or feet
• tremor
• unusual weight gain or loss
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Intramuscular route(Powder for Suspension;Suspension, Extended Release)

Increased Mortality In Elderly Patients With Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Aripiprazole extended-release suspension for IM injection is not approved for the treatment of patients with dementia-related psychosis .

Intramuscular route(Solution)

Warning: Increased Mortality In Elderly Patients With Dementia-Related Psychosis And Suicidal Thoughts And Behaviors With Antidepressant Drugs

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.

Closely monitor all anti-depressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber .

Uses for Abilify

Aripiprazole injection is used to treat agitation caused by schizophrenia or bipolar mania.

Aripiprazole extended-release injection is used to treat schizophrenia (a mental disorder) and bipolar disorder (manic-depressive illness). It works in the brain to change how certain chemicals affect patients. Aripiprazole is an antipsychotic agent.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before using Abilify

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of this medicine in elderly patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving aripiprazole injection. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abiraterone Acetate
• Adagrasib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bentazepam
• Benzhydrocodone
• Boceprevir
• Bromazepam
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Ceritinib
• Cetirizine
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clorazepate
• Clothiapine
• Cloxazolam
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delorazepam
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Diazepam
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Josamycin
• Ketamine
• Ketazolam
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levorphanol
• Lofexidine
• Lonafarnib
• Lopinavir
• Loprazolam
• Lorazepam
• Lormetazepam
• Loxapine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Mavacamten
• Medazepam
• Mefloquine
• Meperidine
• Metaclazepam
• Methadone
• Metronidazole
• Mibefradil
• Midazolam
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nitrazepam
• Nordazepam
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pinazepam
• Pipamperone
• Pitolisant
• Ponesimod
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Ribociclib
• Rifampin
• Rifapentine
• Rilpivirine
• Risperidone
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John’s Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Terbinafine
• Tetrabenazine
• Tetrazepam
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trimipramine
• Triptorelin
• Troleandomycin
• Tucatinib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zolpidem
• Zuclopenthixol
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure, history of or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (decrease in the volume of blood) or
• Ischemic heart disease, history of or
• Trouble with swallowing—Use with caution. May cause side effects to become worse.

• Depression or
• Diabetes, or family history of or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Hyperglycemia (high blood sugar) or
• Neuroleptic malignant syndrome (NMS), history of or
• Neutropenia (low white blood cells) or
• Reduced white blood cell count, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

Proper use of Abilify

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It will be given as a shot into a muscle in your arm or buttock.

This injection is given together with the oral medicine for the first dose. The second dose and the injections that follow are given instead of the oral medicine. Be sure to keep all appointments for the injections.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Be sure to keep all appointments for the injections.

Precautions while using Abilify

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and help reduce any unwanted effects. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase risk for stroke in elderly patients with dementia. Tell your doctor right away if you have confusion, difficulty in speaking, slow speech, inability to speak, inability to move the arms, legs, or facial muscles, double vision, or headache while using this medicine.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may add to the effects of alcohol and other medicines that make you drowsy or less alert. Some examples of these medicines are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics (medicines that numb), including some dental anesthetics. If you are taking any of these medicines, make sure you tell your doctor before you receive aripiprazole injection.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, including gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. Avoid places that are very hot. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of Abilify

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Difficulty with speaking
• drooling
• loss of balance control
• muscle trembling, jerking, or stiffness
• restlessness
• shuffling walk
• stiffness of the limbs
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

Less common

• Blurred vision
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• nervousness
• pounding in the ears
• sticking out the tongue
• trouble breathing or swallowing
• unusual facial expressions

Rare

• Fast heartbeat
• high fever
• increased sweating
• lip smacking or puckering
• loss of bladder control
• muscle spasm or jerking of all extremities
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• seizures
• severe muscle stiffness
• sudden loss of consciousness
• tiredness
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• unusually pale skin

Incidence not known

• Black, tarry stools
• chest pain or tightness
• cough
• hives or welts, itching, or skin rash
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Infection from breathing foreign substance into the lungs
• seizure that will not stop
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Belching
• difficulty having a bowel movement
• dry mouth
• fear
• fever
• heartburn
• hyperventilation
• inability to sit still
• indigestion
• irritability
• lightheadedness
• need to keep moving
• runny nose
• shaking
• stomach discomfort, upset, or pain
• trouble sleeping
• weight gain

Less common

• Accidental injury
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• congestion
• difficulty with moving
• hoarseness
• increased appetite
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• sneezing
• stuffy nose
• swollen joints
• tender, swollen glands in the neck
• tingling of the hands or feet
• tremor
• unusual weight gain or loss
• voice changes

Incidence not known

• Hiccups

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

What is Abilify Maintena?

Abilify Maintena (aripiprazole) extended-release injection is used alone or in combination with other aripiprazole preparations to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Abilify Maintena injection is also used for the ongoing treatment of people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods)

Abilify Maintena belongs to a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Abilify Maintena is an extended-release injectable suspension given once a month. 

Abilify Maintena side effects

Common Abilify Maintena side effects

Common Abilify Maintena side effects may include:

• Increase in weight 17%
• An inability to remain still (akathisia) 11%
• Constipation 10%
• Injection site pain 5%
• Sedation 5%
• Dry mouth 4%
• Upper respiratory tract infection 4%
• Decrease in weight 4%
• Dizziness 4%
• Diarrhea 3%
• Vomiting 3%
• Muscle and joint pain 3%
• Tremor 3%
• Abdominal discomfort 2%
• Nasal congestion 2%.

These common side effects occured in 2% or more of patient treated with Abilify Mantena over a 12 week clinical trial that was double-blind and placebo-controlled Trial.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder  (tardive dyskinesia) that may not be reversible. The longer you use Abilify Maintena, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Abilify Maintena may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Abilify Maintena is not approved for use in older adults with psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with Abilify Maintena if you are allergic to aripiprazole.

Tell your doctor if you have never taken Abilify Maintena.

Abilify Maintena may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Maintena is safe for you, tell your doctor if you have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

How is Abilify Maintena given?

Abilify Maintena is injected into a muscle once a month by your healthcare provider.

Your doctor may occasionally change your dose and dosing schedule.

If you have never used Abilify Maintena, you may need to take aripiprazole by mouth (in tablet or liquid form) before you receive your first injection.

You will need to continue taking aripiprazole by mouth for 14 days after your first injection. Follow your doctor’s dosing instructions very carefully.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Use Abilify Maintena as prescribed by your doctor. If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor’s advice.

Abilify Maintena Dosing Information

Usual Adult Abilify Maintena Dose for Schizophrenia:

Initial dose: Abilify Maintena 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection.

General dosing information for schizophrenia

• Before starting therapy with extended-release IM formulations, tolerability should be established with oral formulations; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
• The first dose of the extended-release IM formulation should be given on the same day as the initiation/re-initiation dose; providers should avoid injecting both formulations in the same deltoid or gluteal muscle.
• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• Dose regimen adjustments (including addition of oral supplementation) will be needed for missed doses.

Usual Adult Abilify Maintena Dose for Bipolar Disorder:

Initial dose: 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection

General dosing information for bipolar disorder

• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• The dose recommended for maintenance treatment is the same dose needed to stabilize patients during acute treatment; healthcare providers should periodically reassess need for maintenance treatment.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your aripiprazole injection.

If you miss the second or third doses, and:

• if more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 5 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

If the fourth or subsequent doses are missed:

• if more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 6 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

Abilify Maintena Copay card

With the Abilify Maintena Copay Card ,you may pay as little as $10 a month. The Abilify Maintena Copay CardCopay Card helps you save money on prescriptions with an annual maximum benefit of $8,000 and a monthly $1,400 maximum. 

Who is eligible for the Abilify Maintena Copay Card?

You are eligible for the Abilify Maintena Copay Card if you have commercial or private insurance, a valid prescription, and live in the United States and Puerto Rico.  You are not eligible for the Copay Card if you are under 18 years of age, or are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE.

How do I apply for the copay card?

You can apply for the Abilify Maintena Copay Card online;

What should I avoid while receiving Abilify Maintena?

Avoid getting up too fast from a sitting or lying position, as this may cause dizziness. Also, avoid driving or engaging in hazardous activities until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Drink plenty of fluids while receiving Abilify Maintena to avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect this medicine?

Sometimes it is not safe to use certain medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Abilify Maintena, especially:

• blood pressure medications;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may interact with aripiprazole. Not all possible drug interactions are listed here. To check for drug interactions see Abilify Maintena Interactions.

Does Abilify Maintena interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Abilify Maintena Package Insert

Review the Abilify Maintena Package Insert for more detailed information about this medicine. The Abilify Maintena Package Insert (PI) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more.

Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Abilify Maintena Prescribing Information or FDA label.

Ingredients

Active ingredient: aripiprazole monohydrate.
Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide.

What is Abilify?

Abilify is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Abilify is used to treat the symptoms of psychotic conditions including schizophrenia in adults and children at least 13 years old.

Abilify is also used alone or with a mood stabilizer medicine to treat bipolar I disorder (manic depression) in adults and children at least 10 years old.

Abilify is used with antidepressant medication to treat major depressive disorder in adults.

Abilify is also used in children at least 6 years old to treat Tourette’s disorder and to treat symptoms related to autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

Warnings

Abilify is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

If you also use antidepressant medicine, do not stop using it suddenly.

Before taking this medicine

You should not take Abilify if you are allergic to aripiprazole.

Abilify may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure this medicine is safe for you, tell your doctor if you have:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures; or
• low white blood cell (WBC) counts.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

The liquid form (oral solution) of this medication contains sugar. Before taking Abilify oral solution, tell your doctor if you have diabetes.

Aripiprazole can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria (PKU).

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Abilify pregnancy and breastfeeding warnings (more detail)

How should I take Abilify?

Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Abilify can be taken with or without food.

Swallow the regular tablet whole and do not crush, chew, or break it. Do not split the orally disintegrating tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves. If needed, you may drink liquid to help swallow the dissolved tablet.

Your doctor will need to check your progress on a regular basis.

If you also use antidepressant medicine, do not stop using it suddenly or you could have unpleasant symptoms. Ask your doctor before stopping the antidepressant.

Store at room temperature away from moisture and heat. Abilify liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.

Detailed Abilify dosage information

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, fainting, or coma.

What should I avoid while taking Abilify?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking Abilify, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Abilify side effects

Get emergency medical help if you have signs of an allergic reaction to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

The most common side effects of Abilify may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• uncontrolled muscle movements, shaking, anxiety, feeling restless;
• weight gain;
• nausea, vomiting, constipation;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat;

Oral route(Tablet;Tablet, Disintegrating;Solution)

Warning: Increased Mortality In Elderly Patients With Dementia-Related Psychosis And Suicidal Thoughts And Behaviors With Antidepressant Drugs

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis .Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies . These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older .Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors . Advise families and caregivers of the need for close observation and communication with the prescriber .The safety and efficacy of aripiprazole have not been established in pediatric patients .

Uses for Abilify Mycite

Aripiprazole is used alone or together with other medicines to treat mental conditions such as bipolar I disorder (manic-depressive illness), major depressive disorder, and schizophrenia. It is also used in children to treat irritability associated with autistic disorder and Tourette syndrome. Aripiprazole works in the brain to change how certain chemicals affect patients. It is an antipsychotic agent.

This medicine is available only with your doctor’s prescription. Abilify® oral solution was withdrawn from the market on May 15, 2015 and this dose form is not marketed by any generic manufacturers.

Before using Abilify Mycite

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children younger than 13 years of age with schizophrenia and in children younger than 10 years of age with bipolar disorder. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Abilify Mycite® in children. Safety and efficacy have not been established.

Aripiprazole is not approved for use in children or teenagers with major depression.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children 6 to 17 years of age with autistic disorder.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abiraterone Acetate
• Adagrasib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bentazepam
• Benzhydrocodone
• Boceprevir
• Bromazepam
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Ceritinib
• Cetirizine
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clorazepate
• Clothiapine
• Cloxazolam
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delorazepam
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Diazepam
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Josamycin
• Ketamine
• Ketazolam
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levorphanol
• Lofexidine
• Lonafarnib
• Lopinavir
• Loprazolam
• Lorazepam
• Lormetazepam
• Loxapine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Mavacamten
• Medazepam
• Mefloquine
• Meperidine
• Metaclazepam
• Methadone
• Metronidazole
• Mibefradil
• Midazolam
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nitrazepam
• Nordazepam
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pinazepam
• Pipamperone
• Pitolisant
• Ponesimod
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Ribociclib
• Rifampin
• Rifapentine
• Rilpivirine
• Risperidone
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John’s Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Terbinafine
• Tetrabenazine
• Tetrazepam
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trimipramine
• Triptorelin
• Troleandomycin
• Tucatinib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zolpidem
• Zuclopenthixol
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Depression or
• Diabetes, or family history of or
• Drug abuse or dependence, history of or
• Hyperglycemia (high blood sugar) or
• Neuroleptic malignant syndrome (NMS), history of or
• Neutropenia (low white blood cells) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Blood vessel disease or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (decrease in blood volume) or
• Ischemic heart disease, history of or
• Trouble with swallowing—Use with caution. May cause side effects to become worse.
• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper use of Abilify Mycite

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Swallow the tablets whole. Do not break, crush, or chew them.

Abilify Mycite® has a sensor in the tablet, which helps track it inside the stomach or bowels. The Abilify Mycite® System comes with a patch (wearable sensor), a smartphone application (app), and a web-based portal. Follow your doctor’s instructions on how to use the medicine.

The Abilify Mycite® tablet is usually detected within 30 minutes after you take it, but there may be a delay of more than 2 hours for the smartphone app and web portal to detect that you have taken the medicine, and sometimes it might not be detected at all.

To apply the Abilify Mycite® patch:

• The app will tell you when to apply or remove the patch. It should be changed weekly or sooner as needed.
• Place the patch to the left side of your body just above the lower edge of your rib cage. Do not put the patch in areas where the skin is scraped, cracked, inflamed, or irritated, or near the area where you had removed the previous patch. The app will help you place the patch in the correct location.
• You may keep the patch on when showering, swimming, or exercising.

Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor’s instructions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets and orally disintegrating tablets):
  • For bipolar mania:
    • Abilify® and Abilify Discmelt®:
      • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    • Abilify Mycite®:
      • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For depression:
    • Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For irritability in children with autistic disorder:
    • Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For schizophrenia:
    • Abilify® and Abilify Discmelt®:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • Abilify Mycite®:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For Tourette’s disorder:
    • Children 6 to 18 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If the Abilify Mycite® tablet is not detected on the app or portal after you take it, do not repeat the dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Abilify Mycite

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may increase the amount of sugar in your blood. Also, the oral liquid form contains sugar. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Do not change the dose or stop taking this medicine without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Side Effects of Abilify Mycite

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Difficulty with speaking
• drooling
• loss of balance control
• muscle trembling, jerking, or stiffness
• restlessness
• shuffling walk
• stiffness of the limbs
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

Less common

• Blurred vision
• dizziness
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sticking out the tongue
• trouble with breathing or swallowing
• unusual facial expressions

Rare

• High fever
• high or low blood pressure
• increased sweating
• lip smacking or puckering
• loss of bladder control
• muscle spasm or jerking of all extremities
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• seizures
• severe muscle stiffness
• sudden loss of consciousness
• tiredness
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• unusually pale skin

Incidence not known

• Hives or welts, itching, or skin rash
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bigger, dilated, or enlarged pupils (black part of the eye)
• diarrhea
• fast, pounding, or irregular heartbeat or pulse
• increased sensitivity of the eyes to light
• lack or loss of strength
• nausea
• sleepiness or unusual drowsiness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Anxiety
• belching
• blurred vision
• difficulty having a bowel movement
• dry mouth
• fear
• fever
• heartburn
• hyperventilation
• inability to sit still
• indigestion
• irritability
• lightheadedness
• need to keep moving
• nervousness
• rash
• runny nose
• shaking
• sore throat
• stomach discomfort, upset, or pain
• trouble sleeping
• weight gain

Less common

• Accidental injury
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• congestion
• coughing
• difficulty with moving
• dryness or soreness of the throat
• hoarseness
• increased appetite
• increased salivation
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• rapid weight gain
• sneezing
• stuffy nose
• swollen joints
• tender, swollen glands in the neck
• tingling of the hands or feet
• tremor
• unusual weight gain or loss
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

What is Abilify Asimtufii?

Abilify Asimtufii is an atypical antipsychotic used for schizophrenia and bipolar I disorder in adults, Abilify Asimtufii is an extended-release injection that is given once every two months.

The exact way in which  Abilify Asimtufii works (mechanism of action) to treat schizophrenia and bipolar I disorder is not known, but it is thought to work by balancing the levels of serotonin and dopamine in the brain.

Abilify (aripiprazole) is also available as Abilify (oral tablets), Abilify MyCite (tablet embedded with an ingestible sensor), and Abilify Maintena (extended-release injection for administration once every month). 

Abilify Asimtufii is a longer-acting slow-release injection that is given every two months, this helps compliance and means patients only need 6 injections per year.

What is Abilify Asimtufii used to treat?

Abilify Asimtufii is an FDA-approved medicine used for the treatment of schizophrenia in adults, and is used alone (monotherapy) as maintenance treatment of bipolar I disorder in adults.

Schizophrenia is a mental illness characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions.

Bipolar I disorder is a mental illness that characterized by unusual shifts in a person’s mood, energy, activity levels, and concentration.

Patients who have schizophrenia or bipolar I disorder require long-term treatment.

Warnings

Abilify Asimtufii is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

Do not stop using aripiprazole suddenly, or you could have unpleasant withdrawal symptoms.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how aripiprazole affects you.

High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

Before taking this medicine

You should not take this medicine if you are allergic to the active ingredient aripiprazole or any of the inactive ingredients. 
This medicine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Asimtufii is safe for you, tell your doctor if you have:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures; or
• low white blood cell (WBC) counts.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

This medicine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine may harm your unborn baby. Receiving this medicine during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you receive this medicine during pregnancy. Do not stop the medicine without your doctor’s advice.

Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment. If you become pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. This medicine can pass into your breast milk, and it is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment.

Abilify Asimtufii pregnancy and breastfeeding warnings (more detail)

How is Abilify Asimtufii given?

For patients who have never taken aripiprazole you must first check their tolerability with oral aripiprazole prior to initiating treatment with this injection. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

Abilify Asimtufii must be given injection given into your buttock muscles by your healthcare provider. Do not administer by any other route.

Abilify Asimtufii is given one time every 2 months.

Patients Receiving Oral Antipsychotics

When Abilify Asimtufii injection is initiated in patients receiving oral aripiprazole, administer the first dose of Abilify Asimtufii along with oral aripiprazole (10 mg to 20 mg) for 14 consecutive days.

For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), administer the first Abilify Asimtufii injection along with the oral antipsychotic for 14 consecutive days.

Patients Receiving Abilify Maintena

For patients receiving Abilify Maintena (once monthly dosing), administer Abilify Asimtufii 960 mg (once every 2 month dosing) in place of the next scheduled injection of the Abilify Maintena. The first Abilify Asimtufii injection may be administered in place of the second, or later injection of Abilify Maintena.

If there are adverse reactions with the 960 mg dosage, the dosage may be reduced to 720 mg once every 2 months.

Patients may be given the Abilify Asimtufii injection up to 2 weeks before or 2 weeks after the 2-month scheduled timepoint.

Dosing information

Usual Abilify Asimtufii Adult Dose for Schizophrenia

Dose: 960 mg administered once every 2 months as a single injection.

Use: for the treatment of schizophrenia in adults.

Comments:

• Dose can be reduced to 720 mg in patients with adverse reactions.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment.
• Administer by intramuscular injection in the gluteal muscle by a healthcare professional. 
• Do not administer by any other route.

Usual Abilify Asimtufii Adult Dose for Bipolar I Disorder

Dose: 960 mg administered once every 2 months as a single injection. 

Use: maintenance monotherapy treatment of bipolar I disorder in adults.

Comments:

• Dose can be reduced to 720 mg in patients with adverse reactions.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment.
• Administer by intramuscular injection in the gluteal muscle by a healthcare professional. Do not administer by any other route.

Detailed Abilify Asimtufii dosage information

What happens if I miss a dose?

If more than 8 weeks and less than 14 weeks have elapsed since the last injection, administer the next dose as soon as possible. The once every 2 month schedule should be resumed.

If more than 14 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

What should I avoid while taking this medicine

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how aripiprazole will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drive a car, operate machinery, or do other dangerous activities until you know how this injection affects you. This medicine may affect your judgement, thinking or motor skills.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking aripiprazole, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Abilify Asimtufii side effects

Get emergency medical help if you have signs of an allergic reaction to aripiprazole: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Abilify Asimtufii side effects may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• uncontrolled muscle movements, shaking, anxiety, feeling restless;
• weight gain;
• nausea, vomiting, constipation;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat;

What is Abilify MyCite Starter Kit?

Abilify MyCite Starter Kit is an antipsychotic medicine that is used to treat adults with schizophrenia.

Abilify MyCite Starter Kit is used alone or with a mood stabilizer medicine to treat adults with bipolar I disorder (manic depression).

Abilify MyCite Starter Kit is used with antidepressant medication to treat major depressive disorder in adults.

Abilify MyCite Starter Kit may also be used for purposes not listed in this medication guide.

Abilify MyCite Starter Kit side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Abilify MyCite Starter Kit may cause serious side effects. Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts–fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Abilify MyCite Starter Kit. Talk with your doctor if this occurs.

Common side effects of Abilify MyCite Starter Kit may include:

• feeling shaky, anxious, or restless;
• nausea, constipation;
• dizziness, drowsiness; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Abilify MyCite Starter Kit is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Before taking this medicine

You should not use Abilify MyCite Starter Kit if you are allergic to it.

Abilify MyCite Starter Kit may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• low white blood cell (WBC) counts;
• seizures; or
• trouble swallowing.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Abilify MyCite Starter Kit can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using Abilify MyCite Starter Kit.

How should I take Abilify MyCite Starter Kit?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Abilify MyCite is a drug and device system that has 4 parts:

• A MyCite tablet with a sensor inside it.
• A MyCite Patch (to wear on your skin) that detects a signal from the sensor in the tablet after you take it, and sends this information to a smartphone.
• A Mycite App (a smartphone app) that records when you took the tablet, and tracks information about your activity, sleep, and mood.
• An online portal to share information from the MyCite App with your healthcare providers.

The Mycite Patch usually detects a tablet within 30 minutes after you take it. If the tablet is not detected, do not repeat the dose.

It may take up to 2 hours or longer for the smartphone app and online portal to detect that you’ve taken a tablet.

You may take Abilify MyCite Starter Kit with or without food.

Your doctor will need to check your progress on a regular basis.

Swallow the tablet whole and do not crush, chew, or break it.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, fainting, or coma.

What should I avoid while taking Abilify MyCite Starter Kit?

Avoid driving or hazardous activity until you know how Abilify MyCite Starter Kit will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

While you are taking Abilify MyCite Starter Kit, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

What other drugs will affect Abilify MyCite Starter Kit?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect Abilify MyCite Starter Kit, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is Abilify Maintena Prefilled Syringe?

Abilify Maintena and Abilify Asimtufii are used in adults to treat schizophrenia and bipolar disorder.

Aristada is used in adults to treat schizophrenia.

Aristada Initio is used together with oral Abilify Maintena Prefilled Syringe to start or restart Aristada.

Abilify Maintena Prefilled Syringe may also be used for purposes not listed in this medication guide.

Abilify Maintena Prefilled Syringe side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use Abilify Maintena Prefilled Syringe, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using Abilify Maintena Prefilled Syringe. Talk with your doctor if this occurs.

Abilify Maintena Prefilled Syringe may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection–fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects of Abilify Maintena Prefilled Syringe may include:

• feeling restless;
• pain where the medicine was injected;
• weight gain; or
• drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Abilify Maintena Prefilled Syringe is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with Abilify Maintena Prefilled Syringe if you are allergic to it.

Tell your doctor if you have never taken Abilify Maintena Prefilled Syringe.

Abilify Maintena Prefilled Syringe may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have or have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using Abilify Maintena Prefilled Syringe.

How is Abilify Maintena Prefilled Syringe given?

If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor’s advice.

If you have never used Abilify Maintena Prefilled Syringe, you may need to take this medicine by mouth (in tablet or liquid form) before you receive your first injection.

You may need to continue taking Abilify Maintena Prefilled Syringe by mouth for up to 3 weeks after your first injection. Follow your doctor’s dosing instructions very carefully.

Abilify Maintena Prefilled Syringe is injected into a muscle. A healthcare provider will give you this injection once every 4 to 8 weeks. Your doctor may occasionally change your dose and dosing schedule.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Abilify Maintena Prefilled Syringe.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

What should I avoid while receiving Abilify Maintena Prefilled Syringe?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how Abilify Maintena Prefilled Syringe will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are receiving Abilify Maintena Prefilled Syringe.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect Abilify Maintena Prefilled Syringe?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Abilify Maintena Prefilled Syringe, especially:

• blood pressure medications;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

What is aripiprazole?

Abilify Maintena and Abilify Asimtufii are used in adults to treat schizophrenia and bipolar disorder.

Aristada is used in adults to treat schizophrenia.

Aristada Initio is used together with oral aripiprazole to start or restart Aristada.

Aripiprazole may also be used for purposes not listed in this medication guide.

Aripiprazole side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use aripiprazole, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Abilify Asimtufii may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection–fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects of Abilify Asimtufii may include:

• feeling restless;
• pain where the medicine was injected;
• weight gain; or
• drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Aripiprazole is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with aripiprazole if you are allergic to it.

Tell your doctor if you have never taken aripiprazole.

Aripiprazole may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have or have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

How is aripiprazole given?

If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor’s advice.

If you have never used aripiprazole, you may need to take aripiprazole by mouth (in tablet or liquid form) before you receive your first injection.

You may need to continue taking aripiprazole by mouth for up to 3 weeks after your first injection. Follow your doctor’s dosing instructions very carefully.

Aripiprazole is injected into a muscle. A healthcare provider will give you this injection once every 4 to 8 weeks. Your doctor may occasionally change your dose and dosing schedule.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your aripiprazole injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

What should I avoid while receiving aripiprazole?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are receiving aripiprazole.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect aripiprazole?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect aripiprazole, especially:

• blood pressure medications;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

What is Abilify?

Abilify is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Abilify is used to treat the symptoms of psychotic conditions including schizophrenia in adults and children at least 13 years old.

Abilify is also used alone or with a mood stabilizer medicine to treat bipolar I disorder (manic depression) in adults and children at least 10 years old.

Abilify is used with antidepressant medication to treat major depressive disorder in adults.

Abilify is also used in children at least 6 years old to treat Tourette’s disorder and to treat symptoms related to autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

Warnings

Abilify is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

If you also use antidepressant medicine, do not stop using it suddenly.

Before taking this medicine

You should not take Abilify if you are allergic to aripiprazole.

Abilify may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure this medicine is safe for you, tell your doctor if you have:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures; or
• low white blood cell (WBC) counts.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

The liquid form (oral solution) of this medication contains sugar. Before taking Abilify oral solution, tell your doctor if you have diabetes.

Aripiprazole can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria (PKU).

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Abilify pregnancy and breastfeeding warnings (more detail)

How should I take Abilify?

Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Abilify can be taken with or without food.

Swallow the regular tablet whole and do not crush, chew, or break it. Do not split the orally disintegrating tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves. If needed, you may drink liquid to help swallow the dissolved tablet.

Your doctor will need to check your progress on a regular basis.

If you also use antidepressant medicine, do not stop using it suddenly or you could have unpleasant symptoms. Ask your doctor before stopping the antidepressant.

Store at room temperature away from moisture and heat. Abilify liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.

Detailed Abilify dosage information

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, fainting, or coma.

What should I avoid while taking Abilify?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking Abilify, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Abilify side effects

Get emergency medical help if you have signs of an allergic reaction to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

The most common side effects of Abilify may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• uncontrolled muscle movements, shaking, anxiety, feeling restless;
• weight gain;
• nausea, vomiting, constipation;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Abilify?

Taking Abilify with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

What is Abilify Maintena?

Abilify Maintena (aripiprazole) extended-release injection is used alone or in combination with other aripiprazole preparations to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Abilify Maintena injection is also used for the ongoing treatment of people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods)

Abilify Maintena belongs to a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Abilify Maintena is an extended-release injectable suspension given once a month. 

Abilify Maintena side effects

Common Abilify Maintena side effects

Common Abilify Maintena side effects may include:

• Increase in weight 17%
• An inability to remain still (akathisia) 11%
• Constipation 10%
• Injection site pain 5%
• Sedation 5%
• Dry mouth 4%
• Upper respiratory tract infection 4%
• Decrease in weight 4%
• Dizziness 4%
• Diarrhea 3%
• Vomiting 3%
• Muscle and joint pain 3%
• Tremor 3%
• Abdominal discomfort 2%
• Nasal congestion 2%.

These common side effects occured in 2% or more of patient treated with Abilify Mantena over a 12 week clinical trial that was double-blind and placebo-controlled Trial.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder  (tardive dyskinesia) that may not be reversible. The longer you use Abilify Maintena, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Abilify Maintena may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Abilify Maintena side effects (more detail)

Warnings

Abilify Maintena is not approved for use in older adults with psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with Abilify Maintena if you are allergic to aripiprazole.

Tell your doctor if you have never taken Abilify Maintena.

Abilify Maintena may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Maintena is safe for you, tell your doctor if you have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Abilify Maintena pregnancy and breastfeeding warnings (more detail)

How is Abilify Maintena given?

Abilify Maintena is injected into a muscle once a month by your healthcare provider.

Your doctor may occasionally change your dose and dosing schedule.

If you have never used Abilify Maintena, you may need to take aripiprazole by mouth (in tablet or liquid form) before you receive your first injection.

You will need to continue taking aripiprazole by mouth for 14 days after your first injection. Follow your doctor’s dosing instructions very carefully.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Use Abilify Maintena as prescribed by your doctor. If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor’s advice.

Abilify Maintena Dosing Information

Usual Adult Abilify Maintena Dose for Schizophrenia:

Initial dose: Abilify Maintena 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection.

General dosing information for schizophrenia

• Before starting therapy with extended-release IM formulations, tolerability should be established with oral formulations; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
• The first dose of the extended-release IM formulation should be given on the same day as the initiation/re-initiation dose; providers should avoid injecting both formulations in the same deltoid or gluteal muscle.
• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• Dose regimen adjustments (including addition of oral supplementation) will be needed for missed doses.

Usual Adult Abilify Maintena Dose for Bipolar Disorder:

Initial dose: 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection

General dosing information for bipolar disorder

• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• The dose recommended for maintenance treatment is the same dose needed to stabilize patients during acute treatment; healthcare providers should periodically reassess need for maintenance treatment.

Detailed Abilify Maintena dosage information

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your aripiprazole injection.

If you miss the second or third doses, and:

• if more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 5 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

If the fourth or subsequent doses are missed:

• if more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 6 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

What happens if I overdose?

Seek emergency medical attention

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

Abilify Maintena Copay card

With the Abilify Maintena Copay Card ,you may pay as little as $10 a month. The Abilify Maintena Copay CardCopay Card helps you save money on prescriptions with an annual maximum benefit of $8,000 and a monthly $1,400 maximum. 

Who is eligible for the Abilify Maintena Copay Card?

You are eligible for the Abilify Maintena Copay Card if you have commercial or private insurance, a valid prescription, and live in the United States and Puerto Rico.  You are not eligible for the Copay Card if you are under 18 years of age, or are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE.

How do I apply for the copay card?

You can apply for the Abilify Maintena Copay Card online; a link is on the Abilify Maintena Price Guide page.

What should I avoid while receiving Abilify Maintena?

Avoid getting up too fast from a sitting or lying position, as this may cause dizziness. Also, avoid driving or engaging in hazardous activities until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Drink plenty of fluids while receiving Abilify Maintena to avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect this medicine?

Sometimes it is not safe to use certain medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Abilify Maintena, especially:

• blood pressure medications;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may interact with aripiprazole. Not all possible drug interactions are listed here. To check for drug interactions see Abilify Maintena Interactions.

Abilify Maintena drug interactions (more detail)

Does Abilify Maintena interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Abilify Maintena Package Insert

Review the Abilify Maintena Package Insert for more detailed information about this medicine. The Abilify Maintena Package Insert (PI) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more.

Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Abilify Maintena Prescribing Information or FDA label.

Ingredients

Active ingredient: aripiprazole monohydrate.
Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide.

What is Abilify Asimtufii?

Abilify Asimtufii is an atypical antipsychotic used for schizophrenia and bipolar I disorder in adults, Abilify Asimtufii is an extended-release injection that is given once every two months.

The exact way in which  Abilify Asimtufii works (mechanism of action) to treat schizophrenia and bipolar I disorder is not known, but it is thought to work by balancing the levels of serotonin and dopamine in the brain.

Abilify (aripiprazole) is also available as Abilify (oral tablets), Abilify MyCite (tablet embedded with an ingestible sensor), and Abilify Maintena (extended-release injection for administration once every month). 

Abilify Asimtufii is a longer-acting slow-release injection that is given every two months, this helps compliance and means patients only need 6 injections per year.

What is Abilify Asimtufii used to treat?

Abilify Asimtufii is an FDA-approved medicine used for the treatment of schizophrenia in adults, and is used alone (monotherapy) as maintenance treatment of bipolar I disorder in adults.

Schizophrenia is a mental illness characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions.

Bipolar I disorder is a mental illness that characterized by unusual shifts in a person’s mood, energy, activity levels, and concentration.

Patients who have schizophrenia or bipolar I disorder require long-term treatment.

Warnings

Abilify Asimtufii is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

Do not stop using aripiprazole suddenly, or you could have unpleasant withdrawal symptoms.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how aripiprazole affects you.

High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

Before taking this medicine

You should not take this medicine if you are allergic to the active ingredient aripiprazole or any of the inactive ingredients. 
This medicine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Asimtufii is safe for you, tell your doctor if you have:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures; or
• low white blood cell (WBC) counts.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

This medicine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine may harm your unborn baby. Receiving this medicine during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you receive this medicine during pregnancy. Do not stop the medicine without your doctor’s advice.

Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment. If you become pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. This medicine can pass into your breast milk, and it is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment.

How is Abilify Asimtufii given?

For patients who have never taken aripiprazole you must first check their tolerability with oral aripiprazole prior to initiating treatment with this injection. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

Abilify Asimtufii must be given injection given into your buttock muscles by your healthcare provider. Do not administer by any other route.

Abilify Asimtufii is given one time every 2 months.

Patients Receiving Oral Antipsychotics

When Abilify Asimtufii injection is initiated in patients receiving oral aripiprazole, administer the first dose of Abilify Asimtufii along with oral aripiprazole (10 mg to 20 mg) for 14 consecutive days.

For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), administer the first Abilify Asimtufii injection along with the oral antipsychotic for 14 consecutive days.

Patients Receiving Abilify Maintena

For patients receiving Abilify Maintena (once monthly dosing), administer Abilify Asimtufii 960 mg (once every 2 month dosing) in place of the next scheduled injection of the Abilify Maintena. The first Abilify Asimtufii injection may be administered in place of the second, or later injection of Abilify Maintena.

If there are adverse reactions with the 960 mg dosage, the dosage may be reduced to 720 mg once every 2 months.

Patients may be given the Abilify Asimtufii injection up to 2 weeks before or 2 weeks after the 2-month scheduled timepoint.

Dosing information

Usual Abilify Asimtufii Adult Dose for Schizophrenia

Dose: 960 mg administered once every 2 months as a single injection.

Use: for the treatment of schizophrenia in adults.

Comments:

• Dose can be reduced to 720 mg in patients with adverse reactions.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment.
• Administer by intramuscular injection in the gluteal muscle by a healthcare professional. 
• Do not administer by any other route.

Usual Abilify Asimtufii Adult Dose for Bipolar I Disorder

Dose: 960 mg administered once every 2 months as a single injection. 

Use: maintenance monotherapy treatment of bipolar I disorder in adults.

Comments:

• Dose can be reduced to 720 mg in patients with adverse reactions.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment.
• Administer by intramuscular injection in the gluteal muscle by a healthcare professional. Do not administer by any other route.

What happens if I miss a dose?

If more than 8 weeks and less than 14 weeks have elapsed since the last injection, administer the next dose as soon as possible. The once every 2 month schedule should be resumed.

If more than 14 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

What should I avoid while taking this medicine

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how aripiprazole will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drive a car, operate machinery, or do other dangerous activities until you know how this injection affects you. This medicine may affect your judgement, thinking or motor skills.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking aripiprazole, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Abilify Asimtufii side effects

Get emergency medical help if you have signs of an allergic reaction to aripiprazole: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Abilify Asimtufii side effects may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• uncontrolled muscle movements, shaking, anxiety, feeling restless;
• weight gain;
• nausea, vomiting, constipation;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Abilify Asimtufii?

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.

Abilify Asimtufii and other medicines may affect each other causing possible serious side effects. This injection may affect the way other medicines work, and vice versa.

Your healthcare provider can tell you if it is safe to receive this injection with your other medicines. Do not start or stop any medicines during treatment without first talking to your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Especially tell your healthcare provider if you take any of the following medicines:

• clarithromycin (Biaxin)
• antidepressants such as fluoxetine (Prozac), paroxetine (Paxil), and nefazodone
• antifungals such as fluconazole (Diflucan), ketoconazole (Nizoral), and itraconazole (Sporanox)
• quinidine
• HIV medicines such as indinavir (Crixivan), ritonavir (Norvir), saquinavir (Fortova, Invirase), and lopinavir/ritonavir (Kaletra)
• carbamazepine (Tegretol)
• rifampin (Rifadin).

To check for interactions with Abilify Asimtufii, click on the link below.

Does Abilify Asimtufii interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Storage

Store at 25°C (77°F), excursions permitted between 15° and 30°C (59° to 86°F)

Ingredients:

Active ingredient: aripiprazole monohydrate.

Inactive ingredients: carboxymethylcellulose sodium, polyethylene glycol 400, povidone, sodium chloride, sodium phosphate monobasic monohydrate, sodium hydroxide and water for injection.

What is Abilify?

Abilify is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Abilify is used to treat the symptoms of psychotic conditions including schizophrenia in adults and children at least 13 years old.

Abilify is also used alone or with a mood stabilizer medicine to treat bipolar I disorder (manic depression) in adults and children at least 10 years old.

Abilify is used with antidepressant medication to treat major depressive disorder in adults.

Abilify is also used in children at least 6 years old to treat Tourette’s disorder and to treat symptoms related to autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

Warnings

Abilify is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

If you also use antidepressant medicine, do not stop using it suddenly.

Before taking this medicine

You should not take Abilify if you are allergic to aripiprazole.

Abilify may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure this medicine is safe for you, tell your doctor if you have:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures; or
• low white blood cell (WBC) counts.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

The liquid form (oral solution) of this medication contains sugar. Before taking Abilify oral solution, tell your doctor if you have diabetes.

Aripiprazole can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria (PKU).

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take Abilify?

Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Abilify can be taken with or without food.

Swallow the regular tablet whole and do not crush, chew, or break it. Do not split the orally disintegrating tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves. If needed, you may drink liquid to help swallow the dissolved tablet.

Your doctor will need to check your progress on a regular basis.

If you also use antidepressant medicine, do not stop using it suddenly or you could have unpleasant symptoms. Ask your doctor before stopping the antidepressant.

Store at room temperature away from moisture and heat. Abilify liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, fainting, or coma.

What should I avoid while taking Abilify?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking Abilify, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Abilify side effects

Get emergency medical help if you have signs of an allergic reaction to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

The most common side effects of Abilify may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• uncontrolled muscle movements, shaking, anxiety, feeling restless;
• weight gain;
• nausea, vomiting, constipation;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Abilify?

Taking Abilify with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.