Yes

Stimulant

Narcolepsy; attention deficit/hyperactivity disorder (ADHD)

C-II

C

Known hypersensitivity or idiosyncrasy to dextroamphetamine or other sympathomimetic amines. Patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension (stage II or III), hyperthyroidism, glaucoma, diabetes mellitus, agitated states, patients with a history of drug abuse, and during or within 14 days following MAO inhibitor therapy. Stimulant medications are contraindicated for use in children with attention deficit/hyperactivity disorders and concomitant Tourette's syndrome or tics.

Use with caution in patients with bipolar disorder, cardiovascular disease, seizure disorders, insomnia, porphyria, mild hypertension (stage I), or history of substance abuse. May exacerbate symptoms of behavior and thought disorder in psychotic patients. Potential for drug dependency exists - avoid abrupt discontinuation in patients who have received for prolonged periods. Use in weight reduction programs only when alternative therapy has been ineffective. Products may contain tartrazine - use with caution in potentially sensitive individuals. Stimulant use in children has been associated with growth suppression.

Cardiovascular: Palpitations, tachycardia, hypertension, cardiomyopathy

Central nervous system: Overstimulation, euphoria, dyskinesia, dysphoria, exacerbation of motor and phonic tics, restlessness, insomnia, dizziness, headache, psychosis, Tourette's syndrome

Dermatologic: Rash, urticaria

Endocrine & metabolic: Changes in libido

Gastrointestinal: Diarrhea, constipation, anorexia, weight loss, xerostomia, unpleasant taste

Genitourinary: Impotence

Neuromuscular & skeletal: Tremor

Symptoms of overdose include restlessness, tremor, confusion, hallucinations, panic, dysrhythmias, nausea, vomiting

There is no specific antidote for dextroamphetamine intoxication and the bulk of the treatment is supportive. Hyperactivity and agitation usually respond to reduced sensory input; however, with extreme agitation, haloperidol (2-5 mg I.M. for adults) may be required.

Hyperthermia is best treated with external cooling measures, or when severe or unresponsive, muscle paralysis with pancuronium may be needed

Hypertension is usually transient and generally does not require treatment unless severe. For diastolic blood pressures >110 mm Hg, a nitroprusside infusion should be initiated.

Seizures usually respond to diazepam I.V. and/or phenytoin maintenance regimens

Amphetamines inhibit the antihypertensive response to guanethidine and guanadrel; consider alternate agents

May precipitate hypertensive crisis or serotonin syndrome in patients receiving MAO inhibitors (selegiline >10 mg/day, isocarboxazid, phenelzine, tranylcypromine, furazolidone). This combination should be avoided

Large doses of antacids (sodium bicarbonate) may inhibit the elimination of dextroamphetamine and increase its effects

TCAs may enhance the effects of amphetamines; avoid use or monitor for CV effects

Urinary acidifiers decrease the half-life and duration of action of amphetamines; dose adjustment may be necessary

Urinary alkalinizers increase the half-life and duration of action of amphetamines; dosage decrease may be necessary

Protect from light

Blocks reuptake of dopamine and norepinephrine from the synapse, thus increases the amount of circulating dopamine and norepinephrine in cerebral cortex to reticular activating system; inhibits the action of monoamine oxidase and causes catecholamines to be released. Peripheral actions include elevated blood pressure, weak bronchodilator, and respiratory stimulant action.

Onset of action: 1-1.5 hours

Metabolism: In the liver

Half-life: Adults: 34 hours (pH dependent)

Time to peak serum concentration: Oral: Within 3 hours

Elimination: In urine as unchanged drug and inactive metabolites after oral dose

Oral:

Narcolepsy: 6-12 years: Initial: 5 mg/day, may increase at 5 mg increments in weekly intervals until side effects appear; maximum dose: 60 mg/day

Attention deficit/hyperactivity disorder:

3-5 years: Initial: 2.5 mg/day given every morning; increase by 2.5 mg/day in weekly intervals until optimal response is obtained, usual range: 0.1-0.5 mg/kg/dose every morning with maximum of 40 mg/day

greater than or equal to 6 years: 5 mg once or twice daily; increase in increments of 5 mg/day at weekly intervals until optimal response is reached, usual range: 0.1-0.5 mg/kg/dose every morning (5-20 mg/day) with maximum of 40 mg/day

Children >12 years and Adults:

Narcolepsy: Initial: 10 mg/day, may increase at 10 mg increments in weekly intervals until side effects appear; maximum: 60 mg/day

Exogenous obesity: 5-30 mg/day in divided doses of 5-10 mg 30-60 minutes before meals

Should be administered 30 minutes before meals and at least 6 hours before bedtime; acidic foods, juices, or vitamin C may decrease GI absorption

Growth in children and CNS activity in all

Use vasoconstriction with caution in patients taking dextroamphetamine. Amphetamines enhance the sympathomimetic response of epinephrine and norepinephrine leading to potential hypertension and cardiotoxicity.

Up to 10% of patients taking dextroamphetamines may present with hypertension. The use of local anesthetic without vasoconstrictor is recommended in these patients.

Take exactly as directed (do not increase dose or frequency without consulting prescriber); may cause physical and/or psychological dependence. Take early in day to avoid sleep disturbance, 30 minutes before meals. Avoid alcohol, caffeine, or OTC medications that act as stimulants. You may experience restlessness, false sense of euphoria, or impaired judgment (use caution when driving or engaging in tasks requiring alertness until response to drug is known); dry mouth (frequent mouth care, sucking lozenges, or chewing gum may help); nausea or vomiting (small frequent meals, frequent mouth care may help); constipation (increased exercise, dietary fiber, fruit, or fluid may help); diarrhea (buttermilk, boiled milk, or yogurt may help); or altered libido (reversible). Diabetics need to monitor serum glucose closely (may alter antidiabetic medication requirements). Report chest pain, palpitations, or irregular heartbeat; extreme fatigue or depression; CNS changes (aggressiveness, restlessness, euphoria, sleep disturbances); severe unremitting abdominal distress or cramping; blackened stool; changes in sexual activity; or blurred vision. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Last daily dose should be given 6 hours before retiring; do not crush sustained release drug product

Capsule, as sulfate, sustained release: 5 mg, 10 mg, 15 mg

Elixir, as sulfate: 5 mg/5 mL (480 mL)

Tablet, as sulfate: 5 mg, 10 mg (5 mg tablets contain tartrazine)

Grinstead GF, "Ranitidine and High Concentrations of Phenylpropanolamine Cross React in the EMIT Monoclonal Amphetamine/Methamphetamine Assay," Clin Chem, 1989, 35(9):1998-9.

Mattson RH and Calverley JR, "Dextroamphetamine-Sulfate-Induced Dyskinesias," JAMA, 1968, 204(5):400-2.

Richards CF, Clark RF, Holbrook T, et al, "The Effect of Cocaine and Amphetamines on Vital Signs in Trauma Patients," J Emerg Med, 1995, 13(1):59-63.

Segar DL, "Substances of Abuse: Topics," Emerg Med, 1985, 7:18-30.

Warden C and Winger J, "Choreoathetoid Reaction Associated With a Methylphenidate Ingestion in a Toddler," Clin Toxicol, 1995, 33(5):522.