Medication Information
Lisdexamfetamine dimesylate (generic) ~ Vyvanse (brand)

Classification: Amphetamine.

Common Usage: Lisdexamfetamine dimesylate is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children 6-12 years, as an integral part of a total treatment program that may include other measures (i.e. psychological, educational, social). The safety and efficacy of lisdexamfetamine dimesylate in patients 3-to-5-years old have not been established. Amphetamines are not recommended for use in children under 3 years old.

The safety and effectiveness of lisdexamfetamine dimesylate for long-term use (i.e. more than 4 weeks) have not been established.

Warnings:
Contraindications: Lisdexamfetamine dimesylate is not recommended for patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity to the sympathomimetic amines, or glaucoma. Lisdexamfetamine dimesylate is also contraindicated in individuals in agitated states, those with a history of drug abuse; and during or within 14 days following the administration of monoamine oxidase inhibitors.

Dependence: Vyvanse (lisdexamfetamine dimesylate) is classiified as a Schedule II controlled substance. Amphetamines such as lisdexamfetamine dimesylate have a high potential for abuse. Administration of lisdexamfetamine dimesylate for prolonged periods of time may lead to drug dependence.

Serious cardiovascular events: Stimulant products like lisdexamfetamine dimesylate should not be used in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary heart disease, or other serious cardiac problems that may place them at increased risk of sudden death. (See Contraindications.)

Pre-existing psychosis and emergence of new psychotic or manic symptoms: Administration of stimulants like lisdexamfetamine dimesylate may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder. Also, treatment emergent psychotic or manic symptoms (e.g., hallucinations, delusional thinking or mania) in children and adolescents without prior history of psychotic illness can be caused by stimulants at usual doses. Patients should be carefully monitored for such symptoms.

Bipolar illness: Particular care should be taken in using lisdexamfetamine dimesylate to treat ADHD patients who also have bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Patients should be carefully screened prior to initiating treatment.

Aggression: Aggressive behavior or hostility is often observed in children and adolescents with ADHD and has been associated with some medications indicated to treat ADHD. Patients should be monitored for the appearance of or worsening of aggressive behavior.

Long-term suppression of growth: Growth should be monitored during treatment with lisdexamfetamine dimesylate and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

Seizures: It is possible that some stimulants may lower the convulsive threshold in patients with a prior history of seizure. In the presence of seizures, lisdexarnfetamine dirnesylate should be discontinued.

Tics: Amphetamines such as lisdexamfetamine dimesylate have been reported to exacerbate motor and phonic tics and Tourette's syndrome.

Pregnancy and Nursing: Pregnancy Category C: amphetamines like lisdexamfetamine dimesylate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines are excreted in human milk; mothers taking lisdexamfetamine dimesylate should be advised to refrain from nursing.

Geriatric patients: Lisdexamfetamine dimesylate has not been studied in the geriatric population.

Important Side Effects: Adverse events occurring in patients taking lisdexamfetamine dimesylate have included upper abdominal pain, decreased appetite, dizziness, dry mouth, irritability, insomnia, nausea, vomiting and decreased weight. In rare cases, serious skin rashes, such as Stevens Johnson Syndrome, have been reported.

This is not a complete list of all known or potential adverse effects. Notify your doctor of any symptoms that have started since you began taking this medication, changing its dose, or adding or changing other medication or diet. Take care when performing any task (for example, driving or operating machinery) that requires your attention until you have experience with this drug and are confident you can perform the task safely.

Interactions with Other Medications: Lisdexamfetamine dimesylate should not be used in combination with any MAGI antidepressants or within 14 days of treatment with an MAGI. Lisdexamfetamine dimesylate may enhance the activity of tricyclic antidepressants or sympathomimetic agents. Some tricyclics cause significant increases in the concentration of ampthetamine in the brain, with possible cardiovascular effects. Amphetamines such as lisdexamfetamine dimesylate could decrease the efficacy of antihistamines, adrenergic blockers, and ethosuximide. Lisdexamfetamine dimesylate may interact with antihypertensives, haloperidol, lithium carbonate, meperidine, norepinephrine, Phenobarbital, phenytoin, and propoxyphene.

This is not a complete list of all known or potential drug interactions. To help prevent problems, always make sure that all prescribers know about all medications you are taking, including over-the-counter drugs, dietary herbal supplements, folk or home remedies.

Common Dosages: The recommended administration of lisdexamfetamine dimesylate is in the morning, with or without food. Afternoon doses should be avoided due to the potential for insomnia. Vyvanse capsules can be taken whole or the capsule can be opened and the entire contents dissolved in water. The dose of a single capsule should not be divided.

Dosage should be individualized according to therapeutic need and response of the patient. The lowest effective dose of lisdexamfetamine dimesylate should be used. The following dosage information is intended as a general guideline only. Always follow the direction of the prescribing clinician regarding dosing.

In children with ADHD, 6-to-12-years-old, either starting treatment for the first time or switching from another medication, 30 mg once daily in the morning is the recommended starting dose. If a decision is made to increase the dose beyond 30 mg/day, it can be adjusted in increments of 20 mg/day at roughly weekly intervals. The maximum recommended dose in children is 70 mg/day.

Identification: Vyvanse capsules are available in 30 mg, 50 mg and 70 mg capsules. The 30 mg capsules have a white body with an orange cap, and are imprinted with NRP104 30 mg. The 50 mg capsules have a white body with a blue cap, and are imprinted with NRP104 50 mg. The 70 mg capsules have a blue body with an orange cap, and are imprinted with NRPI04 70 mg.

Storage: Store at 77° F (25° C). Excursions permitted to 59° and 86° F. Store in a tightly closed, child-, light-, and moisture-resistant container. If you have difficulty opening child-resistant containers, your pharmacist can provide you with a container that is easier to open. Keep it out of direct sunlight and avoid storing it in a warm and humid area - such as the bathroom or kitchen - to prevent deterioration. To prevent accidental poisoning, keep all medications out of the reach of children. Do not take an expired medication. Do not transfer medication from one container to another. Carefully discard discontinued medication where children cannot find it.