Pronunciation: DEX-troe-am-FET-a-meen SUL-fate
- Tablets 5 mg
- Capsules, ER 5 mg
- Capsules, ER 10 mg
- Capsules, ER 15 mg
- Tablets 5 mg
- Solution, oral 1 mg/mL
Activates noradrenergic neurons, which causes CNS and respiratory stimulation; stimulates satiety center in brain, which causes appetite suppression.
Well absorbed. T max is approximately 3 h (immediate-release tablets) and approximately 8 h (ER capsules). C max is 33.2 ng/mL (solution).
Widely distributed with high concentrations in the brain.
Metabolized in the liver by hydroxylation, N-deakylation, and deamination.
Half-life is approximately 12 h (urine pH less than 5.6, half-life is 7 to 8 h; urine pH alkaline, half-life is 18.6 to 33.6 h). Average urinary recovery is 38% in 48 h (solution).
Indications and Usage
Treatment of narcolepsy; treatment of attention-deficit hyperactivity disorder (ADHD).
Advanced arteriosclerosis; symptomatic CV disease; moderate to severe hypertension; hyperthyroidism; hypersensitivity or idiosyncratic reactions to sympathomimetic amines; glaucoma; agitated states; history of drug abuse; during or within 14 days of MAOI use.
Dosage and AdministrationAttention-Deficit Hyperactivity Disorder
Children 6 y of age and older
PO 5 mg once or twice daily; may increase weekly by 5 mg to max of 40 mg/day in divided doses. Usual range is 0.1 to 0.5 mg/kg/dose every morning.Children 3 to 5 y of age
PO 2.5 mg/day; may increase weekly by 2.5 mg. Usual range is 0.1 to 0.5 mg/kg/dose every morning.Narcolepsy
Adults (older than 12 y of age)
PO 10 mg/day; may increase weekly by 10 mg to max of 60 mg/day in divided doses.Children (6 to 12 y of age)
PO 5 mg/day; may increase weekly by 5 mg to max of 60 mg/day in divided doses.
- Do not crush or open ER tablets.
Dispense in a tight, light-resistant container. Store at 15° to 30°C (59° to 86°F).
Drug InteractionsAcidifiers (eg, ammonium chloride, ascorbic acid)
May decrease amphetamine levels.Alkalinizers (eg, acetazolamide, sodium bicarbonate)
May increase amphetamine levels.Anticonvulsants (eg, phenobarbital, phenytoin)
Amphetamine may delay intestinal absorption.Antihypertensives, guanethidine, reserpine, veratrum alkaloids
Amphetamines may decrease effectiveness.Antipsychotics (eg, chlorpromazine, haloperidol), lithium
May decrease amphetamine effect.Furazolidone, MAOIs
Hypertensive crisis and intracranial hemorrhage may occur.Meperidine, norepinephrine, tricyclic antidepressants (eg, amitriptyline)
Amphetamine may enhance activity.
Laboratory Test Interactions
Plasma and urinary steroid levels may be altered.
Dizziness, euphoria, headache, insomnia, nervousness, tremors.
Arrhythmias, hypertension, palpitations, tachycardia.
Dry mouth, unpleasant taste.
Anorexia, diarrhea, constipation.
Drug dependence may develop with prolonged use. Avoid prolonged periods of use.
Amphetamines have a high abuse/diversion potential.
Prescribe/dispense sparingly because of high diversion potential.
Misuse of amphetamines may cause sudden death and serious CV adverse events.
Monitor all patients for changes in heart rate and BP and for the appearance or worsening of aggressive behavior or hostility. Monitor growth in children.
Category C .
Excreted in breast milk.
Do not use as anorectic agent in children younger than 12 y of age. Not recommended for ADHD in children younger than 3 y of age.
Some products contain tartrazine, which may cause allergic reactions in susceptible individuals.
Use with caution; use may induce a mixed/manic episode.
Do not use in patients with known serious structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems.
May occur. Use with caution in patients with preexisting hypertension, heart failure, recent MI, or ventricular arrhythmia.
May exacerbate preexisting psychosis. Emergence of new psychotic/manic symptoms may occur.
Stimulants may lower the convulsive threshold.
Tolerance may occur; do not exceed the recommended dose to overcome this.
Difficulties with accommodation and blurring of vision may occur.
Abdominal cramps, arrhythmias, circulatory collapse, coma, confusion, convulsions, depression, diarrhea, fatigue, hallucinations, hyperreflexia, hypertension, hypotension, nausea, panic, restlessness, tremor, vomiting.
- Advise patients to read the Medication Guide prior to use and with each refill.
- Instruct patient to take medication early in morning and, if possible, to take last dose at bedtime.
- Tell patient to record body weight weekly.
- Instruct patient/family to measure height monthly if the patient is a child.
- Tell patient to limit intake of coffee, tea, cocoa, chocolate, and caffeinated soft drinks.
- Explain importance of good oral hygiene to prevent or treat dry mouth and changes in breath odor.
- Instruct patient to be aware of increased agitation, dizziness, and palpitations, and to take precautions while performing tasks that require physical coordination or mental alertness.
- Advise patients that amphetamines may impair their ability to engage in potentially hazardous activities, such as operating machinery or vehicles.
Copyright © 2009 Wolters Kluwer Health.
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