Dextroamphetamine Sulfate

Pronunciation: DEX-troe-am-FET-a-meen SUL-fate
Class: Amphetamine

Trade Names

Dexedrine
- Tablets 5 mg

Dexedrine Spansules
- Capsules, ER 5 mg
- Capsules, ER 10 mg
- Capsules, ER 15 mg

Dextrostat
- Tablets 5 mg

Procentra
- Solution, oral 1 mg/mL

Pharmacology

Activates noradrenergic neurons, which causes CNS and respiratory stimulation; stimulates satiety center in brain, which causes appetite suppression.

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Pharmacokinetics

Absorption

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).

Distribution

Widely distributed with high concentrations in the brain.

Metabolism

Metabolized in the liver by hydroxylation, N-deakylation, and deamination.

Elimination

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).

Contraindications

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 Administration

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.

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.

PO 10 mg/day; may increase weekly by 10 mg to max of 60 mg/day in divided doses.

PO 5 mg/day; may increase weekly by 5 mg to max of 60 mg/day in divided doses.

General Advice

• Do not crush or open ER tablets.

Storage/Stability

Dispense in a tight, light-resistant container. Store at 15° to 30°C (59° to 86°F).

Drug Interactions

May decrease amphetamine levels.

May increase amphetamine levels.

Amphetamine may delay intestinal absorption.

Amphetamines may decrease effectiveness.

May decrease amphetamine effect.

Hypertensive crisis and intracranial hemorrhage may occur.

Amphetamine may enhance activity.

Laboratory Test Interactions

Plasma and urinary steroid levels may be altered.

Adverse Reactions

CNS

Dizziness, euphoria, headache, insomnia, nervousness, tremors.

Cardiovascular

Arrhythmias, hypertension, palpitations, tachycardia.

Dermatologic

Urticaria.

EENT

Dry mouth, unpleasant taste.

GI

Anorexia, diarrhea, constipation.

Genitourinary

Impotence.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

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.

Tartrazine Sensitivity

Some products contain tartrazine, which may cause allergic reactions in susceptible individuals.

Bipolar disorder

Use with caution; use may induce a mixed/manic episode.

Cardiac effects

Do not use in patients with known serious structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems.

Hypertension

May occur. Use with caution in patients with preexisting hypertension, heart failure, recent MI, or ventricular arrhythmia.

Psychosis

May exacerbate preexisting psychosis. Emergence of new psychotic/manic symptoms may occur.

Seizures

Stimulants may lower the convulsive threshold.

Tolerance

Tolerance may occur; do not exceed the recommended dose to overcome this.

Visual disturbances

Difficulties with accommodation and blurring of vision may occur.

Overdosage

Symptoms

Abdominal cramps, arrhythmias, circulatory collapse, coma, confusion, convulsions, depression, diarrhea, fatigue, hallucinations, hyperreflexia, hypertension, hypotension, nausea, panic, restlessness, tremor, vomiting.

Patient Information

• 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.

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