Cobenfy (xanomeline and trospium chloride) is a new treatment for schizophrenia used to improve positive and negative symptoms. Cobenfy contains xanomeline, which helps schizophrenia symptoms, and trospium, which works to reduce the side effects. Cobenfy is a new class of medicine and works differently than traditional schizophrenia medications so it does not have a boxed warning and atypical antipsychotic class warnings and precautions.

Schizophrenia is related to imbalances in messenger systems in the brain involving muscarinic acetylcholine and dopamine. It is thought that Cobenfy works by xanomeline activating muscarinic receptors  (M1 and M4) in the brain (central nervous system), which improves schizophrenia. Trospium chloride cannot enter the brain easily, so it works mainly around the body, reducing side effects by blocking muscarinic receptors.

Cobenfy has two mechanisms of action (MOA). Cobenfy’s active ingredient xanomeline’s MOA is a muscarinic agonist that selectively targets M1 and M4 receptors in the brain without blocking D2 receptors. Cobenfy’s active ingredient trospium chloride’s MOA is a muscarinic antagonist that blocks the muscarinic receptors primarily in the peripheral tissues.

Cobenfy FDA approval is for the treatment of schizophrenia in adults. Cobenfy capsules are taken twice daily on an empty stomach, at least 1 hour before a meal or at least 2 hours after a meal. During drug development, it was named KarXT, and once approved, Bristol Myers Squibb renamed it Cobenfy.

What is the schizophrenia?

Schizophrenia is a mental illness that affects how you think, feel, and behave. Signs and symptoms usually appear first in the teenage years or early adulthood. There are three main areas of symptoms areas, which are positive (hallucinations and delusions), negative (social withdrawal, lack of enjoyment in life), and cognitive impairment (problems with concentration, memory, and decision-making).
Tradition schizophrenia medicines mainly target positive symptoms, whereas Cobenfy helps to improve positive and negative symptoms.

Cobenfy side effects 

Common Cobenfy side effects

The most common Cobenfy side effects were:

• feeling sick (nausea),
• indigestion (dyspepsia),
• constipation,
• vomiting,
• high blood pressure (hypertension),
• abdominal pain,
• diarrhea,
• fast heart rate (tachycardia),
• dizziness,
• and heartburn (gastrointestinal reflux disease).

These side effects occurred in 5% or more of patients, and at least twice the placebo rates in clinical trials.

Serious Cobenfy side effects

Urinary Retention: Cobenfy cause the side effect of urinary retention. Patients may be at increased risk of urinary retention if they are geriatric patients, patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), or diabetic cytopathic patients). It should not be used in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.

Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of Cobenfy, compared to patients with normal hepatic function, which may result in an increased incidence of adverse reactions.

It should not be used in patients with moderate or severe hepatic impairment and is not recommended in patients with mild hepatic impairment. Assess liver enzymes before starting treatment and as clinically indicated during treatment.

Biliary Disease: In clinical studies with Cobenfy, side effects included transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.

It is not recommended for patients with active biliary disease, such as symptomatic gallstones. Assess liver enzymes and bilirubin before starting treatment and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.

Cobenfy should be stopped in the presence of signs or symptoms of substantial liver injury, such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.

Decreased Gastrointestinal Motility: Cobenfy contains trospium chloride which like other antimuscarinic agents, may decrease gastrointestinal motility. Use this medicine with caution in patients with gastrointestinal obstructive disorders due to the risk of gastric retention. Use these capsules with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.

Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with Cobenfy and trospium chloride, an ingredient of Cobenfy. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue medicine and initiate appropriate therapy and/or measures necessary to ensure a patent airway. This medicine is contraindicated in patients with a history of hypersensitivity to trospium chloride.

Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of this medicine. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, Cobenfy should only be used if the potential benefits outweigh the risks and with careful monitoring.

Increases in Heart Rate: Cobenfy can increase heart rate so assess heart rate at baseline and as clinically indicated during treatment with this medicine.

Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, an active ingredient in this medicine, is substantially excreted by the kidney. It is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment.

Central Nervous System Effects: Trospium chloride, an active ingredient in this medicine is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Patients should not to drive or operate heavy machinery until they know how this medicine affects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation.

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

Who should not take this medicine?

Cobenfy should not be taken if you have:

• urinary retention 
• moderate or severe hepatic impairment 
• gastric retention  
• history of hypersensitivity to Cobenfy or trospium chloride (4) 
• untreated narrow-angle glaucoma 

Before taking this medicine

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

• have an enlarged prostate, problems passing urine, or a blockage in your urinary bladder 
• have liver problems 
• have or had gallstones or problems with your bile ducts or pancreas 
• have stomach or intestinal problems including constipation, ulcerative colitis, slow emptying of your stomach, or myasthenia gravis 
• have an eye condition called narrow-angle glaucoma 
• have kidney problems 

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as it is not known if this Cobenfy may harm your unborn baby. If you become pregnant or think you are pregnant during treatment with this medicine, tell your healthcare provider. There is a pregnancy exposure registry for women who take this medicine during pregnancy. The purpose of this registry is to collect information about the health of women exposed to Cobenfy and their baby. If you become pregnant during treatment while taking this medicine, your healthcare provider will register you by calling 1-866-961-2388. 

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Cobenfy passes into your breast milk or if it can harm your baby.

How should I take Cobenfy?

• Take capsule 2 times each day at least 1 hour before a meal or at least 2 hours after a meal. 
• Do not open the capsules. 
• Take this medicine exactly as your healthcare provider tells you. Do not change the dose or stop taking this medicine without first talking to your healthcare provider. 

Cobenfy Dosing Information

Recommended starting Cobenfy dosage

•  50mg/20mg orally twice daily for at least two days, then increase the dosage to 100mg/20mg twice daily for at least five days.
• Dosage may be increased to 125 mg/30 mg orally twice daily based on patient tolerability and response. 
• See the full prescribing information for the recommended titration and maximum recommended dosage.

Geriatric patients: Recommended starting dosage is 50 mg/20mg orally twice daily. Consider a slower titration. The maximum recommended dosage is 100mg/20mg twice daily. (2.3)

General dosing information

• Take at least 1 hour before a meal or at least 2 hours after a meal. 
• Do not open capsules. (2.2) 
• Assess liver enzymes and bilirubin before starting treatment with this medicine and as clinically indicated during treatment. 
• Assess heart rate at baseline and as clinically indicated during treatment with Cobenfy.

Cobenfy capsules are available in strengths: 50mg/20mg, 100mg/20mg, 125mg/30mg (xanomeline/trospium chloride)

What happens if I overdose?

If you take too much Cobenfy call your healthcare provider or Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

Interactions

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cobenfy and other medicines may affect each other, causing side effects. Know the medicines you take and keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Medications that interact with Cobenfy include:

Drugs Eliminated by Active Tubular Secretion: Monitor for increased frequency and/ or severity of adverse reactions related to Cobenfy and to drugs eliminated by active tubular secretion. 

Strong CYP2D6 Inhibitors: Monitor for increased frequency and/or severity of Cobenfy related adverse reactions.

Sensitive Substrates of CYP3A4 or P-glycoprotein: Monitor for increased frequency and/ or severity of adverse reactions from these substrates. 

Antimuscarinic Drugs: Monitor for increased frequency or severity of anticholinergic adverse reactions.

Not all possible interactions are listed here. Other drugs may interact with Cobenfy, including prescription and over-the-counter medicines, vitamins, and herbal products. 

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C)

Cobenfy ingredients 

Active ingredients:  xanomeline and trospium chloride 

Inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, and talc Capsule shell: contains black iron oxide (only100mg/20mg), hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide (only 50mg/20mg and 100mg/20mg)

Citalopram is a prescription medicine used in adults to treat depression.

Citalopram is also used to treat major depressive disorder (MDD).

Citalopram belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Citalopram side effects

Get emergency medical help if you have signs of an allergic reaction to citalopram: 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.

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

• a light-headed feeling, like you might pass out;
• blurred vision, eye pain or redness, seeing halos around lights;
• fast or pounding heartbeats, pain or fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• a seizure;
• unusual bleeding – nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;
• manic episodes – racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or
• low blood sodium – headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Citalopram can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common citalopram side effects may include:

• sexual problems;
• dizziness, drowsiness;
• dry mouth, thirst, increased sweating or urination;
• loss of appetite, nausea, diarrhea, constipation;
• feeling anxious, agitated, or shaky;
• feeling weak or tired, sleep problems (insomnia), yawning;
• increased muscle movement;
• nosebleed, heavy menstrual bleeding; 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.

Warnings

Do not stop taking citalopram without your doctor’s advice.

Citalopram can cause a serious heart problem. Call your doctor right away if you have chest pain, fast or pounding heartbeats, shortness of breath, and sudden dizziness.

You should not use citalopram if you also take pimozide, as the combination can cause problems with your heart rhythm.

Do not use citalopram if you have used a MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine) or have received a methylene blue injection. A fatal reaction may occur.

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.

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.

Do not stop using citalopram without first asking your doctor.

Before taking this medicine

You should not use this medicine if you are allergic to citalopram or escitalopram (Lexapro), or if you also take pimozide.

Do not use citalopram if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take citalopram.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with citalopram could cause a serious condition called serotonin syndrome.

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

• heart problems, high blood pressure, long QT syndrome;
• a stroke;
• bleeding problems;
• sexual problems;
• narrow-angle glaucoma;
• seizures or epilepsy;
• bipolar disorder (manic depression) in you or a family member;
• an electrolyte imbalance (such as low levels of potassium, magnesium, or sodium in your blood); or
• liver or kidney disease.

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.

Taking this medicine during the last 3 months of pregnancy may harm the unborn baby, but stopping the medicine may not be safe for you. Do not start or stop citalopram without asking your doctor.

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

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

How should I take citalopram?

Take citalopram 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.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

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

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your symptoms may not improve for up to 4 weeks.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using citalopram suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Follow your doctor’s instructions about tapering your dose.

You may need frequent vision exams before starting treatment.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Citalopram dosing information

Usual Adult Dose for Depression:

Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 40 mg orally once a day
Maximum dose: 40 mg orally per day

Comments:
-The initial dose may be increased if necessary to 40 mg once a day after at least 1 week of therapy.
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy

Use: Treatment of depression

Usual Geriatric Dose for Depression:

Over 60 years of age:
Recommended dose: 20 mg orally once a day

Comments:
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy.

Use: Treatment of depression

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 citalopram?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with citalopram may cause you to bruise or bleed easily.

Do not drink alcohol.

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

What other drugs will affect citalopram?

Citalopram 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.

Tell your doctor about all your current medicines. Many drugs can interact with citalopram, especially:

• cimetidine;
• a blood thinner (warfarin, Coumadin, Jantoven);
• a diuretic or “water pill”; or
• gatifloxacin or moxifloxacin.

Celexa is a prescription medicine used to treat severe depression in adults, called major depressive disorder (MDD).

Celexa is a selective serotonin reuptake inhibitor (SSRI) that blocks the reuptake of serotonin (5-HT) by the nerves of the central nervous system, which enhances serotonergic activity. The exact way it works in depression is unclear.

Celexa belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Citalopram works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Celexa side effects

Common Celexa side effects may include:

• sexual problems;
• dizziness, drowsiness;
• dry mouth, thirst, increased sweating or urination;
• loss of appetite, nausea, diarrhea, constipation;
• feeling anxious, agitated, or shaky;
• feeling weak or tired, sleep problems (insomnia), yawning;
• increased muscle movement;
• nosebleed, heavy menstrual bleeding; or
• cold symptoms such as stuffy nose, sneezing, or sore throat.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Celexa: hives, difficulty 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.

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

• a light-headed feeling, like you might pass out;
• blurred vision, eye pain or redness, seeing halos around lights;
• fast or pounding heartbeats, pain or fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• a seizure;
• unusual bleeding – nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;
• manic episodes – racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or
• low blood sodium – headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Citalopram can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Celexa.

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

Warnings

Do not stop taking Celexa without your doctor’s advice.

Citalopram can cause a serious heart problem. Call your doctor right away if you have chest pain, fast or pounding heartbeats, shortness of breath, and sudden dizziness.

You should not use Celexa if you also take pimozide, as the combination can cause problems with your heart rhythm.

Do not use Celexa if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine) or have received a methylene blue injection. A fatal reaction may occur.

Antidepressants, such as Celexa, increase the risk of suicidal thoughts and behaviors in young adults. People with depression or mental illness may have thoughts about suicide. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

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.

SSRIs, including Celexa, may cause sexual problems. Symptoms in males may include delayed ejaculation or inability to have an ejaculation, decreased sex drive, problems getting or keeping an erection. Symptoms in females may include decreased sex drive, delayed orgasm, or inability to have an orgasm. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Celexa. There may be treatments your healthcare provider can suggest.

Do not stop using Celexa without first asking your doctor.

Before taking this medicine

You should not use Celexa if you are allergic to citalopram or escitalopram (Lexapro), or if you also take pimozide.

Do not use Celexa if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take Celexa.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with citalopram could cause a serious condition called serotonin syndrome.

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

• heart problems, high blood pressure, long QT syndrome;
• a stroke;
• bleeding problems;
• sexual problems;
• narrow-angle glaucoma;
• seizures or epilepsy;
• bipolar disorder (manic depression) in you or a family member;
• an electrolyte imbalance (such as low levels of potassium, magnesium, or sodium in your blood); or
• liver or kidney disease
• are pregnant or intending to become pregnant
• are breastfeeding.

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.

Pregnancy

Taking this medicine during the last 3 months of pregnancy may harm the unborn baby, but stopping the medicine may not be safe for you. Do not start or stop Celexa without asking your doctor.

If you are pregnant, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. You can register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

There is a less than 2-fold increased risk for severe bleeding after delivery (postpartum hemorrhage) in mothers exposed to SSRIs, particularly in the month before delivery.

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Celexa. There may be treatments your healthcare provider can suggest.

Breastfeeding

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

How should I take Celexa?

Take Celexa 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.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

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

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your symptoms may not improve for up to 4 weeks.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using Celexa suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Follow your doctor’s instructions about tapering your dose.

You may need frequent vision exams before starting treatment.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Celexa dosing information

Usual Adult Dose for Depression:

Initial dose: 20 mg orally once a day
Maintenance dose: 20 to 40 mg orally once a day
Maximum dose: 40 mg orally per day

Comments:
-The initial dose may be increased if necessary to 40 mg once a day after at least 1 week of therapy.
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy

Usual Senior Dose for Depression:

Over 60 years of age:
Recommended dose: 20 mg orally once a day

Comments:
-Doses of 60 mg/day did not demonstrate an advantage in efficacy over 40 mg/day doses.
-Acute episodes of depression may require several months or more of sustained pharmacologic therapy.

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 Celexa?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with citalopram may cause you to bruise or bleed easily.

Do not drink alcohol.

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

What other drugs will affect Celexa?

Citalopram 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.

Tell your doctor about all your current medicines. Many drugs can interact with citalopram, especially:

• cimetidine;
• a blood thinner (warfarin, Coumadin, Jantoven);
• a diuretic or “water pill”;
• methadone, fentanyl, or other opioids; or
• gatifloxacin or moxifloxacin.

SSRIs, including Celexa, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, such as MAOIs. Serotonin syndrome can also occur when these drugs are used alone.

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

Buspirone is an anti-anxiety medicine that affects chemicals in the brain that may be unbalanced in people with anxiety.

Buspirone is used to treat symptoms of anxiety, such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms.

Buspirone is not an anti-psychotic medication and should not be used in place of medication prescribed by your doctor for psychotic disorders.

Warnings

Do not use buspirone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Before taking this medicine

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

Do not use buspirone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

• kidney disease; or
• liver disease.

Buspirone is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether buspirone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Buspirone is not FDA-approved for use by anyone younger than 18 years old, but this medicine has been used in children and adolescents under close medical supervision and at the appropriate dosage.

How should I take buspirone?

Take buspirone exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Some buspirone tablets are scored so you can break the tablet into 2 or 3 pieces in order to take a smaller amount of the medicine at each dose. Do not use a tablet if it has not been broken correctly and the piece is too big or too small. Follow your doctor’s instructions about how much of the tablet to take.

If you have switched to buspirone from another anxiety medication, you may need to slowly decrease your dose of the other medication rather than stopping suddenly. Some anxiety medications can cause withdrawal symptoms when you stop taking them suddenly after long-term use.

This medication can cause false positive results with certain medical tests. You may need to stop using the medicine for at least 48 hours before your test. Tell any doctor who treats you that you are using buspirone.

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

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 .

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol may increase certain side effects of buspirone.

Grapefruit and grapefruit juice may interact with buspirone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Buspirone side effects

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

Call your doctor at once if you have:

• chest pain;
• shortness of breath; or
• a light-headed feeling, like you might pass out.

Common buspirone side effects may include:

• headache;
• dizziness, drowsiness;
• sleep problems (insomnia);
• nausea, upset stomach; or
• feeling nervous or excited.

BuSpar is an anti-anxiety medicine that affects chemicals in the brain that may be unbalanced in people with anxiety.

BuSpar is used to treat anxiety disorders or the symptoms of anxiety, such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms.

BuSpar is not an anti-psychotic medication and should not be used in place of medication prescribed by your doctor for mental illness.

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

Warnings

Do not use BuSpar if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Before taking this medicine

You should not use BuSpar if you are allergic to buspirone.

Do not use BuSpar if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure BuSpar is safe for you, tell your doctor if you have any of these conditions:

• kidney disease; or
• liver disease.

BuSpar is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether buspirone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Buspirone is not FDA-approved for use by anyone younger than 18 years old, but has been used in children in adolescents under close medical supervision. Do not give buspirone to anyone younger than 18 years of age without consulting with a doctor.

How should I take BuSpar?

Take BuSpar exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Some BuSpar tablets are scored so you can break the tablet into 2 or 3 pieces in order to take a smaller amount of the medicine at each dose. Do not use a tablet if it has not been broken correctly and the piece is too big or too small. Follow your doctor’s instructions about how much of the tablet to take.

If you have switched to BuSpar from another anxiety medication, you may need to slowly decrease your dose of the other medication rather than stopping suddenly. Some anxiety medications can cause withdrawal symptoms when you stop taking them suddenly after long-term use.

Buspirone can cause false positive results with certain medical tests. You may need to stop using the medicine for at least 48 hours before your test. Tell any doctor who treats you that you are using BuSpar.

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

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 . Although no deaths have been reported following BuSpar overdose, symptoms may include nausea, vomiting, dizziness, drowsiness or sleepiness, and stomach upset.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol may increase certain side effects of BuSpar.

Grapefruit and grapefruit juice may interact with buspirone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

BuSpar side effects

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

Call your doctor at once if you have:

• chest pain;
• shortness of breath; or
• a light-headed feeling, like you might pass out.

Common BuSpar side effects may include:

• headache;
• dizziness, drowsiness;
• sleep problems (insomnia);
• nausea, upset stomach; or
• feeling nervous or excited.

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 BuSpar?

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. The following medications can interact with BuSpar;

• MAO Inihibitors (including isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine as well as methylene blue injection);
• Amitriptyline;
• Diazepam;
• Haloperidol;
• Nefazodone;
• Trazodone;
• Triazolam or flurazepam;
• Diltiazem or verapamil;
• Antibiotics, including erythromycin and rifampin;
• Antifungals, including itraconazole; or
• Cimetidine.