Vyvanse (New River Pharmaceuticals Inc.)

Vyvanse (New River Pharmaceuticals Inc.) - General Information

Vyvanse (New River Pharmaceuticals Inc.) (L-lysine-d-amphetamine) is a prodrug of the psychostimulant d-amphetamine coupled with the essential amino acid L-lysine. It was developed so that the amphetamine psychostimulant is released and activated more slowly as the prodrug molecule is hydrolyzed consequently cleaving off the amino acid-during the first pass through the intestines and/or the liver. Amphetamines target the trace amine-associated receptor 1 (TAAR1). Amphetamine is also believed to exert its effects by binding to the monoamine transporters (the dopamine transporter or DAT) and increasing extracellular levels of the biogenic amines dopamine, norepinephrine (noradrenaline) and serotonin.

 

Pharmacology of Vyvanse (New River Pharmaceuticals Inc.)

Vyvanse (New River Pharmaceuticals Inc.) is a pro-drug of dextroamphetamine. It works primarily by inducing the release of the neurotransmitters dopamine and norepinephrine from their storage areas in nerve terminals. Both of these transmitters contribute to maintaining alertness, increasing focus, and sustaining thought, effort, and motivation.

 

Vyvanse (New River Pharmaceuticals Inc.) for patients

MEDICATION GUIDE
VYVANSE™
(lisdexamfetamine dimesylate)
C II

Read the Medication Guide that comes with Vyvanse before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child's treatment with Vyvanse.

What is the most important information I should know about Vyvanse?

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

1. 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 Vyvanse. Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with Vyvanse.

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 Vyvanse.

2. 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 Vyvanse, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is Vyvanse?

Vyvanse is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Vyvanse may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

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

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

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Vyvanse?

Vyvanse 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

Vyvanse has not been studied in children less than 6 years old. Vyvanse is not recommended for use in children less than 3 years old.

Vyvanse may not be right for you or your child. Before starting Vyvanse 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.

Can Vyvanse be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Vyvanse and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Vyvanse.

Your doctor will decide whether Vyvanse can be taken with other medicines.

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 Vyvanse without talking to your doctor first.

How should Vyvanse be taken?

Take Vyvanse exactly as prescribed. Vyvanse comes in 3 different strength capsules. Your doctor may adjust the dose until it is right for you or your child.

• Take Vyvanse once a day in the morning.
• Vyvanse can be taken with or without food.
• From time to time, your doctor may stop Vyvanse treatment for awhile to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Vyvanse. Children should have their height and weight checked often while taking Vyvanse. Vyvanse treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much Vyvanse or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Vyvanse?

See "What is the most important information I should know about Vyvanse?" for information on reported heart and mental problems.

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

Common side effects include:

• upper belly pain • dizziness • irritability • nausea • weighloss

• decreased appetitis • dry mouth • trouble sleeping • vomiting

Vyvanse 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.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information

How should I store Vyvanse?

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

General information about Vyvanse

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vyvanse for a condition for which it was not prescribed. Do not give Vyvanse to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Vyvanse. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Vyvanse that was written for healthcare professionals. For more information about Vyvanse, please contact Shire US Inc. at 1-800-828-2088 or visit www.Vyvanse.com.

What are the ingredients in Vyvanse?

Active Ingredient: lisdexamfetamine dimesylate

Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FC&C Blue #1 and FC&C red #40.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

 

Vyvanse (New River Pharmaceuticals Inc.) Interactions

Urinary acidifying agents—These agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.

Adrenergic blockers—Adrenergic blockers are inhibited by amphetamines.

Antidepressants, tricyclic—Amphetamines may enhance the activity of tricyclic antidepressants or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

MAO inhibitors—MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.

Antihistamines—Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives—Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine—Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines and can be used to treat amphetamine poisoning.

Ethosuximide—Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol—Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.

Lithium carbonate—The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Meperidine—Amphetamines potentiate the analgesic effect of meperidine.

Methenamine therapy—Urinary excretion of amphetamines is increased, and efficacy is reduced by acidifying agents used in methenamine therapy.

Norepinephrine—Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital—Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin—Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene—In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum alkaloids—Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions: Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

 

Vyvanse (New River Pharmaceuticals Inc.) Contraindications

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

 

Additional information about Vyvanse (New River Pharmaceuticals Inc.)

Vyvanse (New River Pharmaceuticals Inc.) Indication: For the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in pediatric populations aged 6 to 12 years.
Mechanism Of Action: Vyvanse (New River Pharmaceuticals Inc.) is a pro-drug of dextroamphetamine. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Norepinephrine and dopamine contribute to maintaining alertness, increasing focus, and sustaining thought, effort, and motivation. However, the exact therapeutic action in ADHD is not known.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Lisdexamfetamine
Synonyms: Not Available
Drug Category: Central Nervous System Agents
Drug Type: Small Molecule; Approved

Other Brand Names containing Lisdexamfetamine: Vyvanse (New River Pharmaceuticals Inc.);
Absorption: After oral administration, lisdexamfetamine is rapidly absorbed from the gastrointestinal tract.
Toxicity (Overdose): Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
Protein Binding: Not Available
Biotransformation: Lisdexamfetamine is converted to dextroamphetamine and L-lysine, which is believed to occur by first-pass intestinal and/or hepatic metabolism. Lisdexamfetamine is not metabolized by cytochrome P450 enzymes.
Half Life: The plasma elimination half-life of lisdexamfetamine typically averaged less
than one hour.
Dosage Forms of Vyvanse (New River Pharmaceuticals Inc.): Capsule, extended release Oral
Chemical IUPAC Name: (2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide; methanesulfonic acid
Chemical Formula: C17H33N3O7S2
Lisdexamfetamine on Wikipedia: https://en.wikipedia.org/wiki/Lisdexamfetamine
Organisms Affected: Humans and other mammals