Concerta is a central nervous system stimulant prescription medicine. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Concerta extended-release tablets are used to treat attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older, adolescents, and in adults up to the age of 65.

Concerta should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Is Concerta a controlled substance?

Yes, Concerta (methylphenidate) is a Schedule 2 controlled substance and therefore has a high potential for abuse. It has a currently accepted medical use in the United States or a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence. There may be variations in CSA schedules between individual states.

Warnings

You should not use Concerta if you have glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation.

Methylphenidate may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse. Keep the medication where others cannot get to it.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Call your doctor right away if you have chest pain or feel lightheaded or short of breath while taking Concerta.

Do not use Concerta if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine or have used a methylene blue injection.

Concerta may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. Call your doctor right away if you have signs of psychosis such as paranoia, aggression, new behavior problems, or seeing or hearing things that are not real.

Before taking this medicine

You should not use Concerta if you are allergic to methylphenidate.

You should not take Concerta if you have:

• glaucoma;
• severe high blood pressure or a heart problem;
• overactive thyroid;
• a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

Do not use Concerta 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.

Tell your doctor if you also use 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 methylphenidate could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet; or
• alcoholism or drug addiction.

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

• problems with the esophagus, stomach, or intestines; or
• seizures, epilepsy, or an abnormal brain wave test (EEG).

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain.

Concerta is not approved for use by anyone younger than 6 years old.

How should I take Concerta?

Take Concerta 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.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Concerta is against the law.

Take Concerta once each day in the morning. Concerta is an extended-release tablet. It releases medication into your or your child’s body throughout the day.

Concerta can be taken with or without food, but take it the same way each time.

Do not chew, crush, or break the Concerta tablets. Swallow the tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow the tablet whole. A different medicine may need to be prescribed.

The Concerta tablet does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.

Children should have their height and weight checked often while taking this medicine.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Your doctor will need to check your progress on a regular basis. From time to time, your doctor may stop treatment for a while to check ADHD symptoms. Your heart and blood pressure may also need to be checked often.

Store Concerta tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

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 . An overdose of methylphenidate could be fatal.

Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Concerta?

Avoid drinking alcohol.

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

Concerta side effects

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

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

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.

Methylphenidate can affect growth in children. Your child’s height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common Concerta side effects may include:

• sweating, increased blood pressure;
• mood changes, anxiety, feeling nervous or irritable, trouble sleeping;
• fast heart rate, pounding heartbeats or fluttering in your chest;
• loss of appetite, weight loss;
• dry mouth, nausea, vomiting, stomach pain, indigestion; or
• headache, dizziness.

What is Focalin?

Focalin is a mild stimulant to the central nervous system. It affects chemicals in the brain that contribute to hyperactivity and impulse control.

Focalin is a  prescription medicine used to treat attention deficit hyperactivity disorder (ADHD).

Focalin should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Warnings

Do not use Focalin if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, or methylene blue injection.

You should not use Focalin if you have glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation.

Focalin may be habit-forming, and dexmethylphenidate is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse. Keep the medication where others cannot get to it.

Stimulants such as Focalin have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Focalin may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Focalin may cause blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems–chest pain, feeling light-headed or short of breath; signs of psychosis – paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems – unexplained wounds on your fingers or toes.

Before taking this medicine

You should not take Focalin if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

Do not use Focalin 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.

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 Focalin could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet; or
• alcoholism or drug addiction.

Becoming dependent on Focalin during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dexmethylphenidate on the baby.

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

Focalin is not approved for use by anyone younger than 6 years old.

How should I take Focalin?

Take Focalin 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.

Dexmethylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Focalin is against the law.

Focalin is usually taken twice per day, at least 4 hours apart.

You may take Focalin with or without food. Take the regular tablet twice daily, at least 4 hours apart. Take the extended-release  capsule once daily in the morning.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Dosing information

Usual Adult Dose of Focalin for Attention Deficit Disorder:

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart
Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day (10 mg twice a day)

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:
-Initial dose: 10 mg orally once a day
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half of the total daily dose of methylphenidate orally once a day
For patients CURRENTLY on dexmethylphenidate immediate-release (IR):
-Initial dose: Same dexmethylphenidate IR daily dose orally once a day
Adjust dose weekly in 10 mg increments according to the needs and responses
-Maximum dose: 40 mg/day.

Usual Pediatric Dose of Focalin for Attention Deficit Disorder:

Age 6 years or older:

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart
Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:
-Initial dose: 5 mg orally once a day
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half of the total daily dose of methylphenidate orally once a day
For patients CURRENTLY on dexmethylphenidate immediate-release (IR):
-Initial dose: Same dexmethylphenidate IR daily dose orally once a day
Adjust dose weekly in 5 mg increments according to the needs and responses
-Maximum dose: 30 mg/day

Comments:
-The dose should be individualized according to the needs and response of the patient.
-The immediate-release tablets should be taken twice a day at least 4 hours apart (with or without food); the extended-release  capsules should be taken once a day in the morning (with or without food); if necessary, the capsule may be opened and sprinkled onto applesauce (see Administration Advice).
-If paradoxical aggravation of symptoms or other adverse reactions occur, dose reduction or discontinuation may be necessary.
-If improvement is not observed after 1-month of optimal dosing, this drug should be discontinued.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD).

What happens if I miss a dose?

Take Focalin 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 . An overdose of dexmethylphenidate could be fatal.

Overdose symptoms may include dry mouth, vomiting, agitation, tremor, muscle twitches, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, seizure (convulsions), or coma.

What should I avoid while taking Focalin?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Focalin side effects

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

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new thought or behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

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.

Dexmethylphenidate can affect growth in children. Your child’s height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common Focalin side effects may include:

• loss of appetite;
• nausea, stomach pain; or
• fever.

What is Jornay PM?

Jornay PM is a once-a-day capsule used to treat attention deficit hyperactivity disorder (ADHD). It contains a central nervous system (CNS) stimulant called methylphenidate hydrochloride.

It’s not known exactly how Jornay PM works in people with ADHD, but it is a stimulant that increases activity in the brain, especially in the areas that help regulate behavior and attention. It helps to boost the levels of dopamine and noradrenaline, which are chemical messengers (neurotransmitters), by preventing their re-uptake from the space between nerve cells (neurons) in the brain. Low levels of these chemical messengers have been found in people with ADHD.

Jornay PM is taken in the evening. Each capsule contains two layers. The outside layer is designed to delay the release of the drug so that it doesn’t start to be released until about 12 hours after it is taken. The inside layer extends the amount of time the drug is released into your body for. The two-layer approach is designed to help ensure Jornay PM is working when you wake up and keeps working during the day.

Medications containing methylphenidate, such as Jornay PM, are schedule II federally controlled substances because they can be a target for people who abuse prescription medicines or street drugs. Selling or giving away Jornay PM may harm others, and is against the law.

Jornay PM was approved for use by the US Food and Drug Administration (FDA) in 2018, although methylphenidate in another formulation was first approved many years earlier in 1955.

What is Jornay PM used for?

Jornay PM is a prescription medicine used for the treatment of ADHD in people 6 years of age and older. It may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.

It is not known if it is safe and effective in children under 6 years of age.

Important information

Jornay PM can cause serious side effects, including:

• Abuse and dependence. This medication contains methylphenidate. Jornay PM, other methylphenidate containing products, and amphetamines, have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with this medication.
  • Tell your healthcare provider if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Heart-related problems, including:
  • sudden death, stroke, and heart attack in adults
  • sudden death in children who have heart problems or heart defects
  • increased blood pressure and heart rate
    
    Your healthcare provider should check you or your child carefully for heart problems before starting this medication. Tell your healthcare provider if you or your child has any heart problems, heart defects, or high blood pressure.
    
    Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with this medication.
    
    Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment.
• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
    
    Tell your healthcare provider about any mental problems you or your child has, or about a family history of suicide, bipolar illness, or depression.
    
    Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Who should not take Jornay PM?

Do not take Jornay PM if you or your child is:

• allergic to methylphenidate hydrochloride, or any of the ingredients in Jornay PM. See below for a complete list of ingredients.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

What should I tell my doctor before taking Jornay PM?

Before taking Jornay PM, tell your or your child’s healthcare provider about all medical conditions, including if you or your child:

• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers or toes

How should I take Jornay PM?

• Take Jornay PM exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose and timing of the dose if needed.
• Take by mouth 1 time each day in the evening between 6:30 p.m. and 9:30 p.m.
• Take at the same time each evening. Jornay PM should not be taken in the morning.
• Take with or without food, but take it the same way each time.
• Jornay PM capsules may be swallowed whole, or if the capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto applesauce. Make sure to sprinkle all the contents of the capsule onto the applesauce. The dose should not be divided.
  • Swallow all the applesauce and medicine mixture right away
  • Do not chew the applesauce and medicine mixture
  • Do not store the applesauce and medicine mixture
• Your healthcare provider may sometimes stop treatment with this medication for a while to check for ADHD symptoms.

What happens if I miss a dose?

If a dose of Jornay PM is missed, it should be taken as soon as you remember the same evening. If you do not remember until the next morning you should not take the dose. Wait until that evening to take the next scheduled dose. A missed dose should not be taken in the morning.

What happens if I overdose?

If you or your child takes too much Jornay PM, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Jornay PM?

Avoid drinking alcohol during treatment with Jornay PM. This may cause a faster release of the medicine.

Dosing information

The recommended starting dose of Jornay PM for patients 6 years and over is 20 mg daily in the evening. The dose may be increased weekly in increments of 20 mg up to a maximum daily dose of 100 mg. Jornay PM should be taken between 6:30 pm and 9:30 pm. The timing of the dose can be adjusted within this window to help reduce side effects and ensure it is working when needed the following day.

See the Full Prescribing Information for further details about Jornay PM dosing.

What are the side effects of Jornay PM?

Jornay PM can cause serious side effects, including:

• See “Important information” above.
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develops priapism, get medical help right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
  • fingers or toes may feel numb, cool, or painful
  • fingers or toes may change color from pale, to blue, to red
    
    Tell your healthcare provider if you or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
    
    Call your healthcare provider right away if you or your child has any signs of unexplained wounds appearing on fingers or toes during treatment with this medication.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment. Treatment may be stopped if your child is not gaining weight or height.

The most common side effects of methylphenidate products in children, adolescents, and adults with ADHD include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings (affect liability)
• increased heart rate
• increased blood pressure

The most common side effects of Jornay PM, in children age 6 to 12 with ADHD include:

• trouble sleeping
• decreased appetite
• restlessness (psychomotor hyperactivity)
• headache
• nausea
• mood swings
• vomiting

These are not all the possible side effects of this medication.

Call your doctor for medical advice about side effects. You may report side effects to FDA .

Interactions

Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Jornay PM and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment.

Your healthcare provider will decide whether Jornay PM can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes medicine to treat depression, including MAOIs.

Know the medicines that you or your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

What is lisdexamfetamine?

Lisdexamfetamine is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) in adults and in children who are at least 6 years old.

Lisdexamfetamine is also used to treat moderate to severe binge eating disorder in adults. lisdexamfetamine is not to be used for obesity or weight loss.

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

Lisdexamfetamine 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.

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

• signs of heart problems–chest pain, trouble breathing, pounding heartbeats or fluttering in your chest, feeling like you might pass out;
• signs of psychosis–hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia; or
• signs of circulation problems–numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes.

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.

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

Common side effects of lisdexamfetamine may include:

• dry mouth, loss of appetite, weight loss;
• sleep problems (insomnia);
• fast heart rate, feeling jittery;
• dizziness, feeling anxious or irritable; or
• nausea, vomiting, stomach pain, diarrhea, constipation.

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

Lisdexamfetamine may be habit-forming, and lisdexamfetamine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use lisdexamfetamine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Lisdexamfetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems–chest pain, feeling light-headed or short of breath; signs of psychosis–paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems–unexplained wounds on your fingers or toes.

What should I discuss with my doctor before taking lisdexamfetamine?

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

Do not use lisdexamfetamine 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, tranylcypromine, and others.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• kidney disease;
• coronary artery disease (clogged arteries);
• blood circulation problems in the hands or feet; or
• drug or alcohol addiction.

Some medicines can interact with lisdexamfetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take 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. Ask your doctor before making any changes in how or when you take your medications.

It is not known whether this medicine will harm an unborn baby. However, taking the medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Lisdexamfetamine can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.

Lisdexamfetamine is not approved to treat ADHD in a child younger than 6 years old. Lisdexamfetamine is not approved to treat binge eating disorder in anyone younger than 18 years old.

How should I take lisdexamfetamine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take lisdexamfetamine in larger or smaller amounts or for longer than recommended.

Lisdexamfetamine may be habit-forming. Never share lisdexamfetamine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take lisdexamfetamine with or without food, first thing in the morning.

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

The chewable tablet must be chewed before you swallow it.

Do not crush, chew, break, or divide a lisdexamfetamine capsule. Swallow it whole.

To make swallowing easier, you may open the lisdexamfetamine capsule and sprinkle the medicine into a glass of water or orange juice, or mix it with yogurt. After the medicine has dissolved, drink or eat the mixture right away. Do not save for later use.

While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. Lisdexamfetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Throw away unused or expired lisdexamfetamine in a sealed container or bag. Ask your pharmacist where to locate a community pharmaceutical take back disposal program.

Lisdexamfetamine dosing information

Usual Adult Dose for Attention Deficit Disorder:

Initial dose: 30 mg orally once a day in the morning
Maintenance dose: 30 mg to 70 mg per day; may adjust dosage in increments of 10 mg or 20 mg at approximately weekly intervals.
Maximum dose: 70 mg per day

Comments: Prior to treatment, assess for the presence of cardiac disease and the risk of abuse.

Use: Attention Deficit Hyperactivity Disorder (ADHD)

Usual Adult Dose for Eating Disorder:

Initial dose: 30 mg orally once a day in the morning
Maintenance dose: 50 mg to 70 mg per day; titrate dose in increments of 20 mg at approximately weekly intervals.
Maximum dose: 70 mg per day

Comments: Discontinue this drug if binge eating does not improve.

Use: Moderate to Severe Binge Eating Disorder

Usual Pediatric Dose for Attention Deficit Disorder:

Age 6 to 17 Years:
Initial dose: 30 mg orally once a day in the morning
Maintenance dose: 30 mg to 70 mg per day; may adjust dosage in increments of 10 mg or 20 mg at approximately weekly intervals.
Maximum dose: 70 mg per day

Comments: Prior to treatment, assess for the presence of cardiac disease and the risk of abuse.

Use: Attention Deficit Hyperactivity Disorder (ADHD)

What happens if I miss a dose?

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. 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 . An overdose of lisdexamfetamine can be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.

What should I avoid while taking lisdexamfetamine?

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

What is modafinil?

Modafinil promotes wakefulness and is used to treat excessive daytime sleepiness caused by narcolepsy, obstructive sleep apnea (OSA), or shift work sleep (SWS) disorder.

• Modafinil does not treat the underlying disorder, it only makes people feel more awake.
• Modafinil does not take the place of other treatments for narcolepsy or OSA. These should be continued while you are taking modafinil.

Modafinil’s exact mechanism of action is unclear. However, it’s believed to work by affecting brain chemicals that regulate sleep and wakefulness. While similar to stimulants like amphetamine and methylphenidate, modafinil has a different chemical structure. Modafinil belongs to the drug class called CNS stimulants.

Modafinil is classified as a Schedule IV (4) controlled substance due to its potential for misuse and dependence. Misuse of modafinil is illegal and harmful and you should always keep it in a safe place and never share it with others. Tell your doctor if you have a history of substance abuse.

Modafinil gained FDA approval on December 24, 1998, under the brand name Provigil. Modafinil is available as a generic and under the brand name Provigil.

Modafinil side effects

The most common side effects of modafinil are:

• a headache
• dizziness
• feeling nervous or anxious
• back pain
• nausea
• diarrhea
• an upset stomach
• sleep problems (insomnia)
• poor appetite
• a stuffy nose.

Weight loss is not a recognized side effect of modafinil, although nausea and poor appetite are common side effects of modafinil that may lead to weight loss.

Serious side effects and warnings

You should not use modafinil if you have ever had an allergic reaction or developed a skin rash while taking modafinil, Provigil, armodafinil, or Nuvigil. Angioedema and hypersensitivity reactions (including rash, difficulty swallowing, narrowing of the airways, and hypersensitivity reactions that affect multiple organs) have been reported with medications in the same class as modafinil. Stop taking modafinil and get emergency medical help if you have signs of an allergic reaction to modafinil such as hives (an itchy skin rash), difficulty breathing, or swelling of your face, lips, tongue, or throat.

Modafinil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you develop any of the following, no matter how minor it appears:

• skin rash or hives, blisters or peeling
• mouth sores, trouble swallowing
• fever, shortness of breath
• swelling in your legs
• dark urine, jaundice (yellowing of the skin or eyes)
• swelling in your face, eyes, lips, tongue, or throat.

Modafinil may impair your thinking or reaction time. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activities until you know how this medication will affect your level of wakefulness. Modafinil may not return your level of alertness to what it was before you developed narcolepsy or OSA.

Psychiatric side effects, such as anxiety, confusion, insomnia, depression, or agitation, have been reported in people treated with modafinil. Stop using modafinil and call your doctor at once if you have:

• depression or suicidal thoughts or actions
• anxiety
• hallucinations or unusual thoughts or behavior
• aggression
• being more active or talkative than usual.

Cardiovascular side effects, including chest pain, trouble breathing, uneven heartbeats, shortness of breath, or changes on an ECG have been reported in trials with modafinil. Stop taking modafinil and call your doctor if you have chest pain, trouble breathing, or uneven heartbeats.

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 the FDA.

Before taking

Do not take modafinil if you have ever had an allergic reaction or skin rash while taking modafinil, Provigil, or armodafinil (Nuvigil).

To make sure modafinil is safe for you, tell your doctor about all your medical conditions, including if you have:

• angina (chest pain)
• cirrhosis or other liver problem
• kidney disease
• high blood pressure, heart disease, or history of heart attack
• a history of mental illness or psychosis
• history of alcoholism or drug addiction.
• are pregnant or intending to become pregnant
• are breastfeeding or intending to breastfeed.

Modafinil is not approved for use by anyone younger than 17 years old.

Pregnancy

Based on animal data, modafinil may harm an unborn baby. There have been no adequate studies in humans. Talk to your healthcare provider about using adequate birth control methods while taking Modafinil, if you are a woman of childbearing potential. Be aware that modafinil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment and for one month after finishing your treatment. Talk with your doctor about the best methods of birth control to use while taking modafinil.

A pregnancy registry has been established to collect information on the pregnancy outcomes of women exposed to modafinil if they inadvertently become pregnant while taking modafinil. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll in the registry by calling 1-866-404-4106 (toll-free).

Breastfeeding

It is not known whether modafinil passes into breast milk or if it could harm a nursing baby.

How should I take modafinil?

Take modafinil exactly as prescribed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Do not take this medicine in larger or smaller amounts or for longer than recommended.

• Modafinil may be habit-forming. Never share modafinil with another person, especially someone with a history of drug abuse or addiction.
• Keep the medication where others cannot reach it. Selling or giving away this medicine is against the law.

Modafinil is usually taken 1 time each day.

• Take modafinil in the morning (when you wake up) if you suffer from daytime sleepiness due to narcolepsy or OSA.
• Take modafinil 1 hour before the start of a work shift if you are taking it to treat work-time sleep disorders.

You may take the tablet with or without food.

Modafinil is usually given for 12 weeks or less.

Call your doctor if you continue to have excessive sleepiness even while taking this medicine.

• Taking modafinil does not take the place of getting enough sleep.

Keep track of the amount of medicine used from each new bottle. Modafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Modafinil for OSA

If you take modafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine.

• This machine is an air pump connected to a mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
• Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and modafinil may be necessary to best treat your condition.

Modafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Modafinil dosage

Usual Adult Dose for Narcolepsy:

• Modafinil 200 mg orally daily in the morning.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

• Modafinil 200 mg orally daily in the morning.

Usual Adult Dose for Shift Work Sleep Disorder:

• Modafinil 200 mg orally daily one hour before the start of the work shift.

Modafinil and ADHD

Modafinil is not FDA-approved for use in children for any medical condition including Attention Deficit Hyperactivity Disorder (ADHD).

Studies on children have shown potential risks outweigh any benefits. Serious skin reactions and behavioral issues have been reported. Other side effects reported when modafinil was given to children with narcolepsy included:

• Tourette’s syndrome
• hostile behavior
• increase in sudden loss of muscle tone and severe muscle weakness
• increase in seeing and hearing things when falling asleep
• increase in suicidal thoughts
• low white blood count
• painful menstrual periods.

What happens if I miss a dose?

Talk with your doctor about what to do if you miss a dose of modafinil.

Do not take a dose of modafinil if you remember your dose but it is almost bedtime or you do not plan to be awake for several hours.

• Skip the missed dose. Do not take extra medicine to make up for the missed dose the next day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

What is Nuvigil?

Nuvigil (armodafinil) is an oral prescription medicine that may be used to improve wakefulness in adults who are very sleepy due to narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

• Nuvigil is taken in combination with other treatments for sleep disorders.
• Use of Nuvigil does not replace using your CPAP machine or other treatments that your doctor has prescribed for OSA. Continue to use these treatments.
• Nuvigil is not a cure. It may help the sleepiness caused by these conditions, but it may not stop all your sleepiness and does not take the place of getting enough sleep. Follow your doctor’s advice about good sleep habits and using other treatments.

Nuvigil’s mechanism of action is thought to involve dopamine transporter (DAT) inhibition, although the exact way it works for sleep disorders is not known. While similar to stimulants like amphetamine and methylphenidate, Nuvigil has a different chemical structure. Nuvigil belongs to the drug class called CNS stimulants. 

Nuvigil is classified as a Schedule IV (4) controlled substance due to its potential for misuse and dependence. Misuse is illegal and harmful and you should always keep it in a safe place and never share it with others. Tell your doctor if you have a history of substance abuse.

Nuvigil gained FDA approval on June 15, 2007. A Nuvigil generic is available under the name armodafinil.

Nuvigil side effects

The most common side effects of Nuvigil are:

• headache
• dizziness
• nausea
• sleep problems (insomnia).

Serious side effects and warnings

Nuvigil may cause serious side effects including a serious rash or serious allergic reactions including anaphylaxis, angioedema, and multiorgan hypersensitivity. These may need to be treated in a hospital and may be life-threatening. Stop taking Nuvigil and call your doctor right away or get emergency help if you have any of these symptoms:

• a severe skin reaction that spreads and causes blistering and peeling
• a skin rash, hives, or sores in your mouth
• fever, sore throat, or burning in your eyes
• swelling of your face, eyes, lips, tongue, throat, or lymph nodes
• trouble swallowing, breathing, or hoarseness
• shortness of breath, flu-like symptoms, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine.

Stop taking Nuvigil and seek urgent medical attention at the first sign of rash, no matter how minor it is, unless the rash is not drug-related. These rashes usually occur within 1 to 5 weeks after the first dose. 

Nuvigil may cause the following other serious side effects. 

Mental (psychiatric) symptoms. Symptoms such as depression, anxiety, agitation, nervousness, and irritability, some of which resulted in people stopping Nuvigil, have been reported. May not be suitable for people with a history of psychosis, depression, or mania. Tell your healthcare provider immediately if you develop symptoms such as:

• depression or thoughts of suicide
• hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• feeling anxious
• an extreme increase in activity and talking (mania)
• aggressive behavior.

Persistent sleepiness. Nuvigil may not return a person’s levels of wakefulness to normal and persistent sleepiness may continue despite taking Nuvigil. Tell your healthcare provider if you continue to be sleepy during the day and avoid driving or any other potentially dangerous activity. 

Cardiovascular events have been reported with Nuvigil including chest pain, high blood pressure, palpitations or abnormal heartbeats, shortness of breath, and ECG changes. Some of these patients had preexisting heart disease.  Seek urgent medical attention if you develop symptoms of a heart problem, including chest pain, abnormal heartbeats, or trouble breathing.

It is not known if Nuvigil is safe and effective in children under the age of 18 and it is not approved for use in children.

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

Before taking this medicine

You should not use Nuvigil if you have ever had a rash or allergic reaction caused by armodafinil, Nuvigil, modafinil (Provigil), or any of the inactive ingredients in Nuvigil tablets.

To make sure Nuvigil is safe for you, tell your doctor about all your medical conditions, including if you have ever had:

• liver or kidney disease
• heart disease or a heart muscle or valve disorder such as mitral valve prolapse
• high blood pressure, heart disease, or prior heart attack
• mental illness or psychosis
• drug or alcohol addiction.

Tell your healthcare provider if you are pregnant, intending to become pregnant, or breastfeeding.

Pregnancy

It is not known whether Nuvigil will harm an unborn baby. Nuvigil has been reported to be associated with growth restriction (small fetus) and miscarriage. Tell your doctor if you are pregnant or plan to become pregnant. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not work while you take Nuvigil. Women who use one of these methods of birth control may have a higher chance of getting pregnant while taking Nuvigil and for 1 month after stopping. Use effective birth control while taking Nuvigil and for 1 month after your final dose. Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

There is a registry for women who become pregnant during treatment with Nuvigil. The purpose of this registry is to collect information about the safety of Nuvigil during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106.

Breastfeeding

It is not known whether Nuvigil passes into breast milk or if it could affect the nursing baby. Talk to
your doctor about the best way to feed your baby if you take Nuvigil.

How should I take Nuvigil?

Take Nuvigil 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. Ask your doctor or pharmacist if you have any questions.

Nuvigil is usually taken 1 time a day.

• Nuvigil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.
• You may take this medicine with or without food.
• Do not change the time of day you take Nuvigil unless you have talked to your doctor. If you take Nuvigil too close to your bedtime, you may find it harder to go to sleep.
• Nuvigil is usually given for up to 12 weeks. Follow your doctor’s instructions.

Nuvigil may be habit-forming. Never share Nuvigil with another person, especially someone with a history of drug abuse or addiction. Selling or giving away this medicine is against the law because Nuvigil is a federally controlled substance.

• Keep track of the amount of medicine used from each new bottle. Nuvigil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Nuvigil for OSA

When Nuvigil is used for people with OSA it is usually prescribed with other medications and a CPAP machine.

• A CPAP (continuous positive airway pressure) machine is an air pump connected to the mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
• When you start Nuvigil, do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and Nuvigil may be necessary to best treat your condition.
• Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking this medicine.
• Nuvigil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Nuvigil dosage

Adult Dosage for OSA or Narcolepsy: Nuvigil 150 mg to 250 mg once a day in the morning

Adult Dosage for Shift Work Disorder (SWD): Nuvigil 150 mg once a day, taken approximately one hour before starting your work shift. 

• Liver disease: Reduce the dose of Nuvigil in patients with severe liver disease.
• Geriatric patients: consider a lower dose of Nuvigil.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours.

• If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of Nuvigil. 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 .

Symptoms of an overdose of Nuvigil may include:

• Trouble sleeping
• Confusion
• Feeling excited
• Nausea and diarrhea
• Chest pain
• Anxiety
• Restlessness
• Feeling disoriented
• Hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
• A fast or slow heartbeat
• Shortness of breath.

What to avoid

Do not drive a car or do other dangerous activities until you know how Nuvigil affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.

Avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking Nuvigil.

What other drugs will affect Nuvigil?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Nuvigil and many other medicines can interact with each other, sometimes causing side effects. Nuvigil may affect the way other medicines work, and other medicines may affect how it works. Your dose of Nuvigil or certain other medicines may need to be changed.

Especially, tell your doctor if you use or take hormonal birth control, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs).

• Hormonal birth control methods may not work while you take Nuvigil.
• Women who use one of these methods of birth control may have a higher chance of getting pregnant while taking Nuvigil and for 1 month after stopping.
• Use effective birth control while taking Nuvigil and for 1 month after your final dose.
• Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

Taking Nuvigil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• birth control pills, rings, patches, or other types of hormones
• cyclosporine
• heartburn or antacid medications, such as omeprazole
• seizure medications including phenytoin, diazepam, and others
• antidepressant medications
• blood thinners, such as warfarin (Coumadin, Jantoven)
• beta-blockers, including propranolol, and others.

What is phentermine?

Phentermine is used to speed weight loss in overweight people. It is used together with diet and exercise to treat obesity, especially in people with risk factors such as high blood pressure, high cholesterol, or diabetes.

Phentermine is similar to an amphetamine. It stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.

Phentermine belongs to a class of medications called anorectics. It works by reducing your appetite.

Warnings

Do not use phentermine if you are pregnant or breastfeeding a baby.

You should not use phentermine if you have glaucoma, overactive thyroid, severe heart problems, uncontrolled high blood pressure, advanced coronary artery disease, extreme agitation, or a history of drug abuse.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. A dangerous drug interaction could occur.

Before taking this medicine

You should not use phentermine if you are allergic to it, or if you have:

• a history of heart disease (coronary artery disease, heart rhythm problems, congestive heart failure, stroke);
• severe or uncontrolled high blood pressure;
• overactive thyroid;
• glaucoma;
• extreme agitation or nervousness;
• a history of drug abuse; or
• if you take other diet pills.

Do not use phentermine 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, rasagiline, selegiline, tranylcypromine, and others.

Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Do not use phentermine if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

You should not breast-feed while using this medicine.

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

• heart disease or coronary artery disease;
• a heart valve disorder;
• high blood pressure;
• diabetes (your diabetes medication dose may need to be adjusted); or
• kidney disease.

Phentermine is not approved for use by anyone younger than 16 years old.

How should I take phentermine?

Take phentermine 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.

Doses are normally taken before breakfast, or 1 to 2 hours after breakfast. Follow your doctor’s dosing instructions very carefully.

Never use phentermine in larger amounts, or for longer than prescribed. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects.

This medicine is for short-term use only. The effects of appetite suppression may wear off after a few weeks.

Phentermine may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Call your doctor at once if you think this medicine is not working as well, or if you have not lost at least 4 pounds within 4 weeks.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

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

Dosing information

Usual Adult Dose for Obesity:

8 mg orally 3 times a day 30 minutes before meals, OR
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.

Use: Short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity in patients with an initial body mass index (BMI) of 30 kg/m2 or greater, or BMI of 27 kg/m2 or greater in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Usual Pediatric Dose for Obesity:

Age 17 Years and Older:
8 mg orally 3 times a day 30 minutes before meals, OR
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.

Use: Short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity in patients with an initial body mass index (BMI) of 30 kg/m2 or greater, or BMI of 27 kg/m2 or greater in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is late in the day. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of phentermine can be fatal.

Overdose symptoms may include confusion, panic, hallucinations, extreme restlessness, nausea, vomiting, diarrhea, stomach cramps, feeling tired or depressed, irregular heartbeats, weak pulse, seizure, or slow breathing (breathing may stop).

What to avoid

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

Drinking alcohol with this medicine can cause side effects.

Phentermine side effects

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

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

• feeling short of breath, even with mild exertion;
• chest pain, feeling like you might pass out;
• swelling in your ankles or feet;
• pounding heartbeats or fluttering in your chest;
• tremors, feeling restless, trouble sleeping;
• unusual changes in mood or behavior; or
• increased blood pressure – severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Common side effects of phentermine may include:

• itching;
• dizzinessheadache;
• dry mouth;
• unpleasant taste;
• diarrhea;
• constipation;
• stomach pain; or
• increased or decreased interest in sex.

What is Provigil?

Provigil promotes wakefulness and is used to treat excessive daytime sleepiness caused by narcolepsy, obstructive sleep apnea (OSA), or shift work sleep (SWS) disorder.

• Provigil does not treat the underlying disorder, it only makes people feel more awake.
• Provigil does not take the place of other treatments for narcolepsy or OSA. These should be continued while you are taking Provigil.

Provigil’s exact mechanism of action is unclear. However, it’s believed to work by affecting brain chemicals that regulate sleep and wakefulness. While similar to stimulants like amphetamine and methylphenidate, Provigil has a different chemical structure. Provigil belongs to the drug class called CNS stimulants.

Provigil is classified as a Schedule IV (4) controlled substance due to its potential for misuse and dependence. Misuse of Provigil is illegal and harmful and you should always keep it in a safe place and never share it with others. Tell your doctor if you have a history of substance abuse.

Provigil gained FDA approval on December 24, 1998. A Provigil generic is available under the name modafinil.

Nuvigil is a purified version of Provigil .

Provigil side effects

The most common side effects of Provigil are:

• a headache
• dizziness
• feeling nervous or anxious
• back pain
• nausea
• diarrhea
• an upset stomach
• sleep problems (insomnia)
• poor appetite
• a stuffy nose.

Weight loss is not a recognized side effect of Provigil, although nausea and poor appetite are common side effects of Provigil that may lead to weight loss.

Serious side effects and warnings

You should not use Provigil if you have ever had an allergic reaction or developed a skin rash while taking modafinil, Provigil, armodafinil, or Nuvigil. Angioedema and hypersensitivity reactions (including rash, difficulty swallowing, narrowing of the airways, and hypersensitivity reactions that affect multiple organs) have been reported with medications in the same class as Provigil. Stop taking Provigil and get emergency medical help if you have signs of an allergic reaction to Provigil such as hives (an itchy skin rash), difficulty breathing, or swelling of your face, lips, tongue, or throat.

Provigil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you develop any of the following, no matter how minor it appears:

• skin rash or hives, blisters or peeling
• mouth sores, trouble swallowing
• fever, shortness of breath
• swelling in your legs
• dark urine, jaundice (yellowing of the skin or eyes)
• swelling in your face, eyes, lips, tongue, or throat.

Provigil may impair your thinking or reaction time. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activities until you know how this medication will affect your level of wakefulness. Provigil may not return your level of alertness to what it was before you developed narcolepsy or OSA.

Psychiatric side effects, such as anxiety, confusion, insomnia, depression, or agitation, have been reported in people treated with Provigil. Stop using Provigil and call your doctor at once if you have:

• depression or suicidal thoughts or actions
• anxiety
• hallucinations or unusual thoughts or behavior
• aggression
• being more active or talkative than usual.

Cardiovascular side effects, including chest pain, trouble breathing, uneven heartbeats, shortness of breath, or changes on an ECG have been reported in trials with Provigil. Stop taking Provigil and call your doctor if you have chest pain, trouble breathing, or uneven heartbeats.

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

Before taking

Do not take Provigil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).

To make sure Provigil is safe for you, tell your doctor about all your medical conditions, including if you have:

• angina (chest pain)
• cirrhosis or other liver problem
• kidney disease
• high blood pressure, heart disease, or history of heart attack
• a history of mental illness or psychosis
• history of alcoholism or drug addiction.
• are pregnant or intending to become pregnant
• are breastfeeding or intending to breastfeed.

Provigil is not approved for use by anyone younger than 17 years old.

Pregnancy

Based on animal data, Provigil may harm an unborn baby. There have been no adequate studies in humans. Talk to your healthcare provider about using adequate birth control methods while taking Provigil, if you are a woman of childbearing potential. Be aware that Provigil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment and for one month after finishing your treatment. Talk with your doctor about the best methods of birth control to use while taking Provigil.

A pregnancy registry has been established to collect information on the pregnancy outcomes of women exposed to Provigil if they inadvertently become pregnant while taking Provigil. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll in the registry by calling 1-866-404-4106 (toll-free). 

Breastfeeding

It is not known whether modafinil passes into breast milk or if it could harm a nursing baby. 

How should I take Provigil?

Take Provigil exactly as prescribed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Do not take this medicine in larger or smaller amounts or for longer than recommended.

• Provigil may be habit-forming. Never share Provigil with another person, especially someone with a history of drug abuse or addiction.
• Keep the medication where others cannot reach it. Selling or giving away this medicine is against the law.

Provigil is usually taken 1 time each day.

• Take Provigil in the morning (when you wake up) if you suffer from daytime sleepiness due to narcolepsy or OSA.
• Take Provigil 1 hour before the start of a work shift if you are taking it to treat work-time sleep disorders.

You may take the tablet with or without food.

Provigil is usually given for 12 weeks or less.

Call your doctor if you continue to have excessive sleepiness even while taking this medicine.

• Taking Provigil does not take the place of getting enough sleep.

Keep track of the amount of medicine used from each new bottle. Provigil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Provigil for OSA

If you take Provigil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine.

• This machine is an air pump connected to a mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
• Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and Provigil may be necessary to best treat your condition.

Provigil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor’s instructions about all your other treatments for this disorder.

Provigil dosage

Usual Adult Dose for Narcolepsy:

• Provigil 200 mg orally daily in the morning.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

• Provigil 200 mg orally daily in the morning.

Usual Adult Dose for Shift Work Sleep Disorder:

• Provigil 200 mg orally daily one hour before the start of the work shift.

Provigil and ADHD

Provigil is not FDA-approved for use in children for any medical condition including Attention Deficit Hyperactivity Disorder (ADHD).

Studies on children have shown potential risks outweigh any benefits. Serious skin reactions and behavioral issues have been reported. Other side effects reported when Provigil was given to children with narcolepsy included:

• Tourette’s syndrome
• hostile behavior
• increase in sudden loss of muscle tone and severe muscle weakness
• increase in seeing and hearing things when falling asleep
• increase in suicidal thoughts
• low white blood count
• painful menstrual periods.

What happens if I miss a dose?

Talk with your doctor about what to do if you miss a dose of Provigil.

Do not take a dose of Provigil if you remember your dose but it is almost bedtime or you do not plan to be awake for several hours.

• Skip the missed dose. Do not take extra medicine to make up for the missed dose the next day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Avoid other dangerous activities until you know how Provigil will affect your level of wakefulness.

Avoid drinking alcohol while taking Provigil.

What other drugs will affect Provigil?

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

• Medications that are substrates for CYP3A4/5 (such as contraceptives, cyclosporine, midazolam, and triazolam). These may not be as effective when taken in combination with Provigil
  • Contraceptives in particular may not be as effective while taking Provigil and for one month after discontinuing it.
• Medications that are substrates for CYP2C19 (such as phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may have their effect prolonged by Provigil, leading to an increased risk of side effects or toxicity.
• Warfarin. More frequent monitoring of prothrombin times/INR should be considered whenever Provigil is coadministered with warfarin
• Monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine. Caution should be used when concomitantly administering MAO inhibitors and Provigil.

This is not a complete list of interactions. See the Provigil Prescribing Information for more information.

Storage

Store Provigil tablets at room temperature away from moisture and heat.

Provigil ingredients

Active ingredients: modafinil 100 mg or 200 mg

Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

Available as Provigil 100 mg and Provigil 200 mg.

Who makes Provigil?

Cephalon, LLC manufactures Provigil.

What is QuilliChew ER?

QuilliChew ER is a chewable extended-release tablet used to treat attention deficit hyperactivity disorder (ADHD). The tablet is cherry flavored and is taken each morning. It contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant.

It’s not known exactly how QuilliChew ER and other methylphenidate-containing medications work in people with ADHD, but it does increase activity in the brain, especially in the areas that help regulate behavior and attention. It also helps to boost levels of dopamine and noradrenaline – two chemical messengers or neurotransmitters – by preventing their re-uptake from the space between nerve cells (neurons) in the brain. Low levels of these chemical messengers have been found in people with ADHD.

Methylphenidate-containing medications, such as QuilliChew ER, are schedule II federally controlled substances because they can be a target for people who abuse prescription medicines or street drugs. Selling or giving away QuilliChew ER may harm others, and is against the law.

QuilliChew ER was approved for use by the US Food and Drug Administration (FDA) in 2015, although the first methylphenidate-containing medication was approved many years earlier in 1955.

What is QuilliChew ER used for?

QuilliChew ER is a prescription medicine used for the treatment of ADHD. It may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if it is safe and effective in children under 6 years of age.

Important information

QuilliChew ER can cause serious side effects, including:

• Abuse and dependence. This medication contains methylphenidate. QuilliChew ER, other methylphenidate containing products, and amphetamines, have a high chance for abuse and can cause physical and psychological dependence. Tell your health care provider if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
• Heart-related problems, including:
  • sudden death, stroke, and heart attack in adults
  • sudden death in children who have heart problems or heart defects
  • increased blood pressure and heart rate
    
    Tell your health care provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
    
    Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with this medication.
    
    Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment.
• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
    
    Tell your healthcare provider about any mental problems you or your child has, or about a family history of suicide, bipolar illness, or depression.
    
    Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
• Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
  • Fingers or toes may feel numb, cool, painful
  • Fingers or toes may change color from pale, to blue, to red

Tell your health care provider if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your health care provider right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking this medication.

Who should not take QuilliChew ER?

Do not take QuilliChew ER if you or your child is:

• allergic to methylphenidate hydrochloride, or any of the ingredients in QuilliChew ER. See below for a complete list of ingredients.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

What should I tell my doctor before taking QuilliChew ER?

Before taking QuilliChew ER, tell your or your child’s healthcare provider about all medical conditions (or a family history of), including if you or your child:

• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers or toes
• have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine.

How should I take QuilliChew ER?

• Take this medication exactly as prescribed. Your health care provider may adjust the dose, if needed, until it is right for you or your child. During dose adjustment, you or your child may still have ADHD symptoms.
• Take 1 time each day in the morning. This medication is an extended-release chewable tablet that releases medicine into your body throughout the day.
• The 20 mg and 30 mg QuilliChew ER chewable tablets are scored (bisected) and can be cut in half if needed, for you to get the right dose. QuilliChew ER 40mg is not scored (bisected) and cannot be divided.
• This medication can be taken with or without food.
• From time to time, your health care provider may stop treatment for a while to check ADHD symptoms.
• Your health care provider may do regular checks of the blood, heart, and blood pressure while taking this medication.
• Children should have their height and weight checked often while taking QuilliChew ER. Treatment may be stopped if a problem is found during these check-ups.

What happens if I miss a dose?

If a dose is missed, you or your child should talk to your health care provider about dosing.

What happens if I overdose?

If you or your child takes too much QuilliChew ER, call your poison control center right away, or go to the nearest hospital emergency room.

What should I avoid while taking QuilliChew ER?

Avoid drinking alcohol during treatment with QuilliChew ER. This may cause a faster release of the medicine.

Do not take with MAOI medicines. Do not start taking this medication if you stopped taking an MAOI in the last 14 days.

Dosing information

For patients 6 years and above, the recommended starting dose is QuilliChew ER 20 mg given orally once daily in the morning. The dose may be increased or decreased weekly in increments of 10 mg, 15 mg or 20 mg. Daily dosage above 60 mg is not recommended.

See the Full Prescribing Information for further details about QuilliChew ER dosing.

What are the side effects of QuilliChew ER?

QuilliChew ER can cause serious side effects, including:

• See “Important information” above.
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develops priapism, get medical help right away. Priapism can cause long lasting damage, it should be checked by a health care provider right away.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment. Treatment may be stopped if your child is not gaining weight or height.

The most common side effects of QuilliChew ER include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings
• fast heart beat
• increased blood pressure

These are not all the possible side effects of this medication.

Call your doctor for medical advice about side effects.

Interactions

Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

QuilliChew ER and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment.

Your healthcare provider will decide whether QuilliChew ER can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes medicine to treat depression, including MAOIs.

Know the medicines that you or your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment without talking to your or your child’s healthcare provider first.

Pregnancy and breastfeeding

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether QuilliChew ER will harm your unborn baby.

There is a pregnancy registry for females who are exposed to this medication during pregnancy. The purpose of the registry is to collect information about the health of females exposed to QuilliChew ER and their baby. If you or your child becomes pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961-2388.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. QuilliChew ER passes into breast milk. You and your doctor should decide if you will take QuilliChew ER or breastfeed.

Storage

• Store QuilliChew ER at room temperature between 68°F to 77°F (20°C to 25°C).
• Store in a safe place, like a locked cabinet, to protect it from theft. Never give it to anyone else, because it may cause death or harm them.

Keep out of the reach of children.

What are the ingredients in QuilliChew ER?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: aspartame, cherry flavor, citric acid, crospovidone, D&C red #30 (for 30 mg strength), D&C red #7 (for 40 mg strength), guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, polyvinyl alcohol, povidone, silicon dioxide, sodium polystyrene sulfonate, talc, triacetin, xanthan gum.

What is Quillivant XR?

Quillivant XR is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Quillivant XR extended-release oral suspension is used to treat attention deficit hyperactivity disorder (ADHD). The extended-release oral suspension formulation releases methylphenidate into your body throughout the day.

Quillivant XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Quillivant XR is safe and effective in children under 6 years of age.

Warnings

You should not use Quillivant XR if you have glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation.

Do not use Quillivant XR if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Methylphenidate may be habit-forming, Misuse can cause addiction, overdose, or death.. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems – chest pain, feeling light-headed or short of breath; signs of psychosis – paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems – unexplained wounds on your fingers or toes.

Before taking this medicine

Do not use Quillivant XR 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, tranylcypromine, and others.

You may not be able to use Quillivant XR if you are allergic to methylphenidate, or if you have:

• glaucoma;
• a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

To make sure Quillivant XR is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• motor tics (muscle twitches) or Tourette’s syndrome;
• blood circulation problems in the hands or feet;
• seizures or epilepsy;
• problems with the esophagus, stomach, or intestines;
• an abnormal brain wave test (EEG); or
• drug or alcohol addiction.

Tell your doctor if you are pregnant or breastfeeding.

Quillivant XR is not approved for use by anyone younger than 6 years old.

How should I take Quillivant XR?

Take Quillivant XR 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 methylphenidate. Avoid medication errors by using only the medicine your doctor prescribes.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Never share this medicine with another person. Keep the medicine where others cannot get to it. Selling or giving away Quillivant XR is against the law.

To prevent sleep problems, take this medicine in the morning.

Quillivant XR can be taken with or without food. Taking Quillivant XR with food may shorten the time it takes for the medicine to start working.

Measure liquid Quillivant XR oral suspension with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Tell your doctor if you have a planned surgery.

Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using Quillivant XR.

Store at room temperature away from moisture and heat.

Keep your medicine in a place where no one can use it improperly.

Dosing information

Usual Adult Dose for Attention Deficit Disorder:

Initial Dose: 20 mg orally once a day in the morning. Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved.
Maximum Dose: 60 mg/day.

Usual Pediatric Dose for Attention Deficit Disorder:

6 years or older:
Initial Dose: 20 mg orally once a day in the morning. Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved.
Maximum Dose: 60 mg/day.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is later than 6:00 p.m. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of methylphenidate could be fatal.

What should I avoid while taking Quillivant XR?

Avoid drinking alcohol.

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

Quillivant XR side effects

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

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer (rare).

Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate.

Common Quillivant XR side effects may include:

• excessive sweating;
• mood changes, feeling nervous or irritable, sleep problems (insomnia);
• fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;
• loss of appetite, weight loss;
• dry mouth, nausea, stomach pain; or
• headache.

What is Ritalin?

Ritalin is a central nervous system stimulant. Methylphenidate affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Ritalin is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Ritalin should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Warnings

Ritalin may be habit-forming. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it.

Misuse of Ritalin can cause addiction, overdose, or death. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use Ritalin if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Ritalin may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems – chest pain, feeling light-headed or short of breath; signs of psychosis – paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems – unexplained wounds on your fingers or toes.

Before taking this medicine

You should not use Ritalin if you are allergic to methylphenidate, or if you have.

• glaucoma;
• severe high blood pressure or a heart problem;
• overactive thyroid;
• a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

Do not use Ritalin 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.

Tell your doctor if you also use 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 methylphenidate could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet; or
• alcoholism or drug addiction.

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

• problems with the esophagus, stomach, or intestines; or
• seizures, epilepsy, or an abnormal brain wave test (EEG).

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using Ritalin. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain.

Ritalin is not approved for use by anyone younger than 6 years old.

How should I take Ritalin?

Take Ritalin 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.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Ritalin is against the law.

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.

Ritalin immediate release (IR) tablets are usually taken 2 to 3 times a day. Take Ritalin IR tablets 30 to 45 minutes before a meal.

Ritalin LA extended-release capsule are taken once daily in the morning.

You may take Ritalin LA capsules with or without food, but take them the same way each time.

Swallow the Ritalin LA extended-release capsule whole. If you cannot swallow the capsule whole, open it and mix the medicine with soft food such as applesauce, pudding or yogurt. Swallow the mixture right away without chewing.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Your doctor will need to check your progress on a regular basis. From time-to-time, your doctor may stop Ritalin treatment for a while to check ADHD symptoms. Your heart and blood pressure may also need to be checked often.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

Dosing information

Usual Adult Dose for Attention Deficit Disorder:

• IMMEDIATE-RELEASE (IR): Average dose: 20 to 30 mg orally in 2 or 3 divided doses, preferably 30 to 45 minutes before meals; Maximum dose: 60 mg/day.
• EXTENDED-RELEASE (ER): 8-hour ER oral tablet (e.g., Ritalin SR) – May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day

Usual Adult Dose for Narcolepsy:

• IMMEDIATE-RELEASE (IR): Average dose: 20 to 30 mg orally in 2 or 3 divided doses, preferably 30 to 45 minutes before meals; Maximum dose: 60 mg/day.
• EXTENDED-RELEASE (ER): 8-hour ER oral tablet (e.g., Ritalin SR) – May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day.

Usual Pediatric Dose for Attention Deficit Disorder:

6 years or older

IMMEDIATE-RELEASE (IR): Initial dose: 2.5 to 5 mg orally twice (before breakfast and lunch). Increase dose gradually in increments of 5 to 10 mg per week; individualize dose according to needs and response of patient; Maximum dose: 60 mg/day

EXTENDED-RELEASE (ER):

• 8-hour ER oral tablet (e.g., Ritalin SR): – May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day
• Once daily (50% IR/50% ER) oral capsule (e.g., Ritalin LA):
  • Age: 6 to 12 years of age (methylphenidate-naive): Initial Dose: 20 mg orally once a day in the morning; may initiate at 10 mg orally once a day when a lower dose is appropriate
  • Patients Currently Using Immediate-release (IR) or Sustained-release (SR) Methylphenidate:
• • • Initial dose: 10 mg orally once a day if current IR dose is 5 mg twice a day
    • Initial dose: 20 mg orally once a day if current IR dose is 10 mg 2 times a day or SR dose is 20 mg once a day
    • Initial dose: 30 mg orally once a day if current IR dose is 15 mg 2 times a day
    • Initial dose: 40 mg orally once a day if current IR dose is 20 mg 2 times a day or SR dose 40 mg once a day
    • Initial dose: 60 mg orally once a day if current IR dose is 30 mg 2 times a day or SR dose 60 mg once a day
  • TITRATE gradually in 10 mg increments weekly to optimal response
  • Maximum dose: 60 mg/day.
  • Comments: – All methylphenidate products are FDA approved for pediatric patients 6 years or older with 1 exception; The once daily 50% IR/50% ER oral capsules (Ritalin LA) are approved for patients 6 to 12 years of age only.

Usual Pediatric Dose for Narcolepsy:

6 years or older:

• IMMEDIATE-RELEASE (IR): Initial dose: 5 mg orally twice a day (before breakfast and lunch) – Increase dose gradually in increments of 5 to 10 mg per week; individualize dose according to needs and response of patient; Maximum dose: 60 mg/day.
• EXTENDED-RELEASE (ER): 8-hour ER oral tablet (e.g., Ritalin SR): – May be used when titrated 8-hour IR dose corresponds to available 8-hour ER tablet; available as 20 mg tablets; Maximum dose: 60 mg/day.

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 . An overdose of methylphenidate could be fatal.

Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Ritalin?

Avoid drinking alcohol.

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

Ritalin side effects

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

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

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.

Methylphenidate can affect growth in children. Your child’s height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common Ritalin side effects may include:

• sweating, increased blood pressure;
• mood changes, anxiety, feeling nervous or irritable, trouble sleeping;
• fast heart rate, pounding heartbeats or fluttering in your chest;
• loss of appetite, weight loss;
• dry mouth, nausea, vomiting, stomach pain, indigestion; or
• headache, dizziness.

What is Adderall?

Adderall is used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. Adderall contains a combination of amphetamine and dextroamphetamine. Amphetamine and dextroamphetamine are central nervous system stimulants that affect chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

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

Warnings

Adderall may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use this medicine 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.

Adderall may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems – chest pain, feeling light-headed or short of breath; signs of psychosis – paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems – unexplained wounds on your fingers or toes.

You may not be able to use Adderall if you have glaucoma, overactive thyroid, severe agitation, moderate to severe high blood pressure, heart disease or coronary artery disease, vascular disease, or a history of drug or alcohol addiction.

Before taking this medicine

Do not use this medicine 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, tranylcypromine, and others.

You may not be able to use Adderall if you are allergic to any stimulant medicine. You may not be able to use Adderall if you have:

• glaucoma;
• overactive thyroid;
• severe anxiety or agitation (stimulant medicine can make these symptoms worse);
• high blood pressure;
• heart disease or coronary artery disease;
• vascular disease or hardening of the arteries; or
• a history of drug or alcohol addiction.

Some medicines can interact with amphetamine and dextroamphetamine and cause a serious condition called serotonin syndrome. Tell your doctor about any other medications you are using. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications. Symptom of serotonin syndrome may include agitation, hallucinations (hearing or seeing things that are not real), coma, fast heart rate, dizziness, sweating, feeling hot, muscle rigidity or shakiness, seizures, nausea, vomiting, or diarrhea. Stop Adderall immediately if you experience these symptoms.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

To make sure Adderall is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, anxiety, mental illness, bipolar disorder, psychosis, problems with aggression, or suicidal thoughts or actions;
• motor tics (muscle twitches) or Tourette’s syndrome;
• seizures or epilepsy;
• an abnormal brain wave test (EEG); or
• liver or kidney disease; or
• blood circulation problems in the hands or feet.

Taking Adderall during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

The medications in Adderall (amphetamine and dextroamphetamine) can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine.

Adderall is not approved for use by anyone younger than 3 years old.

How should I take Adderall?

Take Adderall exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Adderall may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

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

You may take Adderall with or without food, first thing in the morning.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

To make swallowing easier, you may open the capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.

Adderall can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.

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

Keep track of your medicine. Adderall is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Dosing information

Usual Adult Dose of Adderall for Attention Deficit Disorder:

IR:
-Initial Dose: 5 mg orally 1 or 2 times a day
-Maintenance Dose: Daily dose may be raised in 5 mg increments at weekly intervals until optimal response is obtained.
-Maximum Dose: Only in rare cases will it be necessary to exceed 40 mg per day.

XR:
Patients starting treatment for the first time or switching from another medication:
-Initial Dose: 20 mg orally once a day

Comments:
-IR: The first dose should be given upon awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
-Where possible, drug administration should be interrupted occasionally to determine if continued therapy is required.

Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD).

Usual Adult Dose of Adderall for Narcolepsy:

IR:
-Initial Dose: 10 mg orally per day in divided doses
-Maintenance Dose: Daily dose may be raised in 10 mg increments at weekly intervals until optimal response is obtained.

Comments:
-The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
-The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
-Dosage should be reduced if bothersome adverse reactions (e.g., insomnia, anorexia) appear.

Use: Narcolepsy treatment

Usual Pediatric Dose of Adderall for Attention Deficit Disorder:

IR:
Age 3 to 5 Years:
-Initial Dose: 2.5 mg orally per day
-Maintenance Dose: Daily dose may be raised in 2.5 mg increments at weekly intervals until optimal response is obtained.

Age 6 to 17 Years:
-Initial Dose: 5 mg orally 1 or 2 times a day
-Maintenance Dose: Daily dose may be raised in 5 mg increments at weekly intervals until optimal response is obtained.
-Maximum Dose: Only in rare cases will it be necessary to exceed 40 mg per day.

XR:
Age 6 to 12 Years (starting treatment for the first time or switching from another medication):
-Initial Dose: 5 or 10 mg orally once a day in the morning
-Maintenance Dose: Daily dose may be raised in 5 to 10 mg increments at weekly intervals.
-Maximum Dose: 30 mg/day

Age 13 to 17 Years (starting treatment for the first time or switching from another medication):
-Initial Dose: 10 mg orally once a day
-Maintenance Dose: Daily dose may be increased to 20 mg/day after one week if symptoms are not adequately controlled.
-Maximum Dose: 30 mg/day

Comments:
-IR: The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
-Where possible, drug administration should be interrupted occasionally to determine if continued therapy is required.

Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD).

Usual Pediatric Dose of Adderall for Narcolepsy:

IR:
Age 6 to 11 Years:
-Initial Dose: 5 mg orally per day in divided doses
-Maintenance Dose: Daily dose may be raised in 5 mg increments at weekly intervals until optimal response is obtained.

Age 12 Years and Older:
-Initial Dose: 10 mg orally per day in divided doses
-Maintenance Dose: Daily dose may be raised in 10 mg increments at weekly intervals until optimal response is obtained.

Comments:
-The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
-The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
-Dosage should be reduced if bothersome adverse reactions (e.g., insomnia, anorexia) appear.
-Narcolepsy rarely occurs in children under 12 years of age.

Use: Narcolepsy treatment

What happens if I miss a dose?

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. 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 . An overdose of Adderall could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, panic, aggressiveness, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, uneven heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

What to avoid

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

Avoid drinking fruit juices or taking vitamin C at the same time you take Adderall. These can make your body absorb less of the medicine.

Adderall side effects

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

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

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
• a seizure (convulsions);
• muscle twitches (tics); or
• changes in your vision.

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.

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

Common side effects of Adderall may include:

• stomach pain;
• loss of appetite;
• weight loss;
• mood changes;
• feeling nervous;
• fast heart rate;
• headache;
• dizziness;
• sleep problems (insomnia); or
• dry mouth.

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 Adderall?

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs Adderall, and may increase side effects.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• buspirone, lithium, selective serotonin reuptake inhibitor (SSRI) drugs (including citalopram, fluoxetine, paroxetine, sertraline, others), tricyclic antidepressants (amitriptyline, others) or other medicine to treat depression or mental illness;
• blood pressure medicine;
• heartburn medicine;
• a blood thinner such as warfarin, Coumadin, Jantoven;
• cold or allergy medicine that contains a decongestant;
• opioid (narcotic) medicine; or
• seizure medicine.

This list is not complete and many other drugs can interact with Adderall. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you