Lisdexamfetamine

Lisdexamfetamine is a prescription medication used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Lisdexamfetamine is also used to treat binge-eating disorder in adults.

Lisdexamfetamine belongs to a group of drugs called central nervous system stimulant medications which help increase attention, decrease impulsiveness, and decrease hyperactivity in people with ADHD, by changing amounts of certain natural substances in the brain.

This medication comes in capsule form and is taken once daily, in the morning.

Common side effects of lisdexamfetamine include dizziness, irritability, and nausea.

Lisdexamfetamine is a prescription medication used for the treatment of attention-deficit hyperactivity disorder (ADHD).

It is approved for:

• the maintenance treatment in children and adolescents ages >6 years with ADHD.
• the treatment of ADHD in adults and children and for maintenance of ADHD in adults 18–55 years old.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Lisdexamfetamine may be found in some form under the following brand names:

• Vyvanse

Lisdexamfetamine may cause serious side effects. See "Drug Precautions".

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision
• worsening of sudden, repeated movements or sounds (tics) and Tourette's syndrome in people who already have these problems

Common side effects include:

• upper belly pain
• dizziness
• irritability
• nausea
• weight loss
• decreased appetite
• dry mouth
• trouble sleeping
• vomiting
• anxiety
• diarrhea

Lisdexamfetamine may affect you or your child's ability to drive or do other dangerous activities. Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
• anti-psychotic medicines
• lithium
• blood pressure medicines
• seizure medicines
• narcotic pain medicines

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking lisdexamfetamine without talking to your doctor first.

Lisdexamfetamine is a stimulant medicine. The following have been reported with use of stimulant medicines.

Heart-related problems:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate
• Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
• Your doctor should check you or your child carefully for heart problems before starting lisdexamfetamine.
• Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with lisdexamfetamine.
• Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking lisdexamfetamine.

Mental (Psychiatric) problems:

All Patients:

• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressive behavior or hostility

Children and Teenagers

• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking lisdexamfetamine, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Lisdexamfetamine should not be taken if you or your child:

• have heart disease or hardening of the arteries
• have moderate to severe high blood pressure
• have hyperthyroidism
• have an eye problem called glaucoma
• are very anxious, tense, or agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• is sensitive to, allergic to, or had a reaction to other stimulant medicines
• lisdexamfetamine has not been studied in children less than 6 years old. lisdexamfetamine is not recommended for use in children less than 3 years old.

Lisdexamfetamine may not be right for you or your child. Before starting lisdexamfetamine tell your or your child's doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• liver or kidney problems
• thyroid problems
• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of lisdexamfetamine there are no specific foods that you must exclude from your diet when receiving lisdexamfetamine.

Before you or your child takes lisdexamfetamine, tell your doctor if you or your child has or if there is a family history of:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette’s syndrome
• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if:

• you or your child is pregnant or plan to become pregnant. It is not known if lisdexamfetamine will harm your unborn baby.
• you or your child is breastfeeding or plan to breastfeed. lisdexamfetamine passes into breast milk. Discuss with your doctor before you breastfeed while you are taking lisdexamfetamine.

Tell your doctor about all of the medicines that you or your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements.

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Lisdexamfetamine falls into category C. There are no well-done studies that have been done in humans with lisdexamfetamine. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Lisdexamfetamine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from lisdexamfetamine, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Take lisdexamfetamine exactly as prescribed. Lisdexamfetamine comes in 6 different strength capsules. Your doctor may adjust the dose until it is right for you or your child.
• Take lisdexamfetamine once a day in the morning.
• Lisdexamfetamine can be taken with or without food.
• From time to time, your doctor may stop lisdexamfetamine treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking lisdexamfetamine. Children should have their height and weight checked often while taking lisdexamfetamine. lisdexamfetamine treatment may be stopped if a problem is found during these check-ups.

Take lisdexamfetamine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The recommended starting dose is 30 mg once daily in the morning in patients ages 6 and above.  Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum dose of 70 mg/day; Doses greater than 70 mg/day have not been studied.

Dosage should be individualized according to the therapeutic needs and response of the patient. Lisdexamfetamine should be administered at the lowest effective dosage.  The least amount of lisdexamfetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

• If you or your child takes too much lisdexamfetamine or overdoses, call your doctor or poison control center right away, or get emergency treatment.

Store lisdexamfetamine in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from light.
Keep lisdexamfetamine and all medicines out of the reach of children.

Lisdexamfetamine is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep lisdexamfetamine in a safe place to prevent misuse and abuse. Selling or giving away lisdexamfetamine may harm others, and is against the law.

WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.