Central nervous system (CNS) stimulant
Lisdexamfetamine dimesylate 30 mg, 50 mg, 70 mg; 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 morning for four weeks.
Significant improvements in behavior were seen for all doses for lisdexamfetamine compared with placebo; improvements were maintained all day, up to approximately 6 pm. 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 with those of placebo. After a three-week open-label dose-titration phase during which Adderall-XR was given, patients were randomized to continue the same dose of Adderall-XR (10 mg, 20 mg, or 30 mg) or they were switched to lisdexamfetamine 30 mg, 50 mg, 70 mg, 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.
>12 years: not recommended.
<6 years: not recommended. 6-12 years: 30 mg once daily in the morning. May increase at intervals of one week by 20 mg/day; max 70 mg/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 monoamine oxidase inhibitors (MAOIs).
Bipolar disorder. Psychoses. Tourette’s syndrome. Tics. Hypertension. Heart failure. Recent MI. Seizures. Drug abusers. Impaired renal, hepatic, or thyroid function. Re-evaluate periodically. Monitor growth, BP, heart rate, worsening aggressive behavior or hostility. Write prescription 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 (e.g., 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 (e.g., psychosis, tics, dizziness, insomnia, irritability), GI upset, rash, upper abdominal pain, decreased appetite/weight, anticholinergic effects.
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