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All about: Lisdexamfetamine Dimesylate

Big Image Pronouncation: (lis-DEX-am-FET-a-meen dye-MEH-sih-LATE)
Class: Amphetamine

Trade Names:
Vyvanse
- Capsules 30 mg
- Capsules 50 mg
- Capsules 70 mg

Mechanism of Action

Pharmacology

Pro-drug for dextroamphetamine, which is thought to block the reuptake of norepinephrine and dopamine into presynaptic neurons and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics

Absorption

Rapidly absorbed from the GI tract and converted to dextroamphetamine and L-lysine. T max of dextroamphetamine is 3.5 h.

Elimination

Approximately 96% of the oral dose is recovered in the urine, with 42% related to amphetamine and 25% to hippuric acid. Plasma t ½ of lisdexamfetamine is less than 1 h.

Indications and Usage

Treatment of attention deficit hyperactivity disorder (ADHD).

Contraindications

Advanced arteriosclerosis; symptomatic CV disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to sympathomimetic amines; glaucoma; agitated states; history of drug abuse; concomitant MAOI use or use within 14 days.

Dosage and Administration

Children 6 to 12 yr of age

PO Start with 30 mg once daily in the morning. Dosage may be adjusted in 20 mg/day increments at approximately weekly intervals (max, 70 mg/day).

General Advice

  • Administer in the morning to avoid potential insomnia.
  • May be taken without respect to food.
  • Capsules may be taken whole, or opened and entire contents dissolved in a glass of water and taken immediately, not stored.
  • Patient should not take less than 1 capsule daily.
  • Interrupt therapy occasionally to determine if there is recurrence of behavioral symptoms sufficient to require continued therapy.

Storage/Stability

Store at 59° to 86°F. Dispense in a tight, light-resistant container.

Drug Interactions

Adrenergic blockers (eg, prazosin, propranolol)

Effects may be inhibited by amphetamines.

Antihistamines

Sedative effects may be decreased by amphetamines.

Antihypertensives, veratrum alkaloids

Hypotensive effect may be antagonized by amphetamines.

Ethosuximide

Intestinal absorption may be delayed by amphetamines.

Furazolidone

Risk of hypertension may be increased.

Lithium

Anorectic and stimulatory effects of amphetamines may be inhibited.

MAOIs (eg, phenelzine)

Increased risk of hypertensive crisis, malignant hyperpyrexia, and death; coadministration of MAOIs and amphetamines is contraindicated.

Meperidine

Analgesic effect of meperidine may be potentiated.

Methenamine, urinary acidifying agents (eg, ammonium chloride)

Enhanced urinary excretion of amphetamines, decreasing the efficacy.

Norepinephrine

Adrenergic effect may be enhanced by amphetamine.

Phenobarbital, phenytoin

Absorption may be delayed by amphetamines; synergistic anticonvulsant activity may occur.

Phenothiazines (eg, chlorpromazine, haloperidol)

Central stimulant effects of amphetamines may be inhibited.

Propoxyphene

Amphetamine CNS stimulation may be potentiated, increasing the risk of fatal seizures.

SSRIs (eg, fluoxetine)

Increased risk of serotonin syndrome.

Tricyclic antidepressants (eg, desipramine)

Activity may be enhanced by amphetamines; d-amphetamine brain concentrations may be increased and sustained; CV effects may be potentiated.

Urinary alkalinizers (eg, sodium bicarbonate)

Decreased urinary excretion of amphetamines, prolonging the effects and possible toxicity of amphetamines.

Laboratory Test Interactions

Interference with urinary steroid determinations.

Adverse Reactions

Cardiovascular

Cardiomyopathy, hypertension, MI, palpitations, sudden death, tachycardia.

CNS

Insomnia (19%); headache (12%); irritability (10%); dizziness (5%); initial insomnia (4%); affect lability (3%); somnolence, tic (2%); change in libido, depression, dysphoria, exacerbation of motor and phonic tics and Tourette syndrome, overstimulation, psychotic episodes, restlessness, seizures, stroke, tremor.

Dermatologic

Rash (3%); Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

GI

Upper abdominal pain (12%); vomiting (9%); nausea (6%); dry mouth (5%); constipation, diarrhea, unpleasant taste.

Genitourinary

Impotence.

Metabolic-Nutritional

Decreased appetite (39%); weight loss (9%).

Miscellaneous

Pyrexia (2%); anaphylaxis, angioedema.

Precautions

Warnings

Misuse of amphetamines may cause sudden death and serious CV adverse reactions. Product has a high potential for abuse. Use for prolonged periods may lead to drug dependence. Since product has high abuse and diversion potential, prescribe or dispense sparingly.


Monitor

Monitor heart rate and BP.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established in children younger than 6 or older than 12 yr of age.

Aggression

Aggressive behavior and hostility have been associated with treatment in children and adolescents.

Bipolar illness

Use with caution because of possible induction of mixed/manic episodes.

CV events

Sudden death associated with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems have occurred. Sudden deaths, stroke, and MI have occurred in adults taking stimulant drugs in ADHD doses.

Growth suppression

Consistently treated children have a temporary slowing in growth rate without evidence of growth rebound.

Hypertension and heart rate

Increases in BP and heart rate may occur.

Manic or psychotic symptoms

Treatment-emergent manic or psychotic symptoms (eg, delusional thinking) may occur.

Psychosis

Symptoms of behavioral disturbance and thought disorders in patients with preexisting psychotic disorders may be exacerbated.

Seizures

The seizure threshold may be lowered in patients with a history of seizures.

Tics

Motor and phonic tics as well as Tourette syndrome may be exacerbated.

Overdosage

Symptoms

Abdominal cramps, arrhythmias, assaultiveness, circulatory collapse, confusion, depression, diarrhea, fatigue, hallucinations, hyperpyrexia and rhabdomyolysis, hyperreflexia, hypertension, hypotension, nausea, panic states, rapid respiration, restlessness, seizures and coma, tremor, vomiting.

Patient Information

  • Advise patient to read the Medication Guide before using product the first time and with each refill.
  • Inform patient that this medication may impair ability to engage in potentially hazardous activities, such as operating machinery or vehicles.

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