Company:

Shire

CNS stimulant

Lisdexamfetamine dimesylate 30mg, 50mg, 70mg; caps.

Attention deficit hyperactivity disorder (ADHD).

After oral administration, lisdexamfetamine is rapidly absorbed from the GI tract and is converted to the active drug dextroamphetamine. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into presynaptic neurons and increase the release of these neurotransmitters into the synapse. The mechanism of action of the amphetamines in treating the symptoms of ADHD has not been established.

In a double-blind, parallel-group study, children 6–12 years old who met the DSM-IV criteria for ADHD were given either fixed-dose lisdexamfetamine or placebo once daily in the AM for 4 wks. Significant improvements in behavior were seen for all doses for lisdexamfetamine compared to placebo; these improvements were maintained throughout the day, up to approximately 6pm. Both investigator rating scales and a parent rating scale was used to assess efficacy.

In a crossover study conducted in children 6–12 years of age who met DSM-IV criteria for ADHD, the effects of lisdexamfetamine and Adderall-XR were compared to those of placebo. After a 3-week open-label dose-titration phase during which Adderall-XR was given, patients were randomized to continue the same dose of Adderall-XR (10mg, 20mg, or 30mg) or they were switched to lisdexamfetamine 30mg, 50mg, 70mg, or placebo. Across the eight sessions of a 12-hour treatment day, a significant difference in behavior between those given lisdexamfetamine and those given placebo was seen.

>12yrs: not recommended.

<6 yrs: not recommended. 6–12yrs: 30mg once daily in AM. May increase at intervals of 1 week by 20mg/day; max 70mg/day. May dissolve contents of capsule in water, take immediately (do not subdivide caps).

Advanced arteriosclerosis. Symptomatic cardiovascular disease. Moderate to severe hypertension. Structural heart defects. Arrhythmias. Hyperthyroidism. Glaucoma. Agitation. Drug abusers. Hypersensitivity or idiosyncrasy to sympathomimetics. Within 14 days of MAOIs.

Bipolar disorder. Psychoses. Tourette’s syndrome. Tics. Hypertension. Heart failure. Recent MI. Seizures. Drug abusers. Impaired renal, hepatic, or thyroid function. Reevaluate periodically. Monitor growth, BP, heart rate, worsening aggressive behavior or hostility. Write for smallest practical amount. Pregnancy (Cat.C). Nursing mothers: not recommended.

See Contraindications. Hypertensive crisis with MAOIs, furazolidone. Potentiated by tricyclics, propoxyphene. Potentiates meperidine, norepinephrine, phenobarbital, phenytoin, tricyclics. Antagonized by urinary acidifiers, psychotropics (eg, haloperidol, chlorpromazine), lithium. Antagonizes adrenergic blockers, antihistamines, antihypertensives. Monitor phenytoin, ethosuximide, phenobarbital. Convulsions with propoxyphene overdose. Caution with other sympathomimetics. May interfere with urinary steroid tests.

Cardiovascular and CNS effects (eg, psychosis, tics, dizziness, insomnia, irritability) GI upset, rash, upper abdominal pain, decreased appetite/weight, anticholinergic effects (eg, blurred vision, dry mouth).

Caps—100

For more information call (800) 828-2088 or visit www.Vyvanse.com.

6/27/07