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 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.

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.

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)

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.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

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 at 1-800-FDA-1088.

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 lisdexamfetamine, and may increase side effects.

Other drugs may interact with lisdexamfetamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to lisdexamfetamine.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking lisdexamfetamine.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.