Dexedrine Spansule

— THERAPEUTIC CATEGORIES —
  • ADHD
  • Sleep-wake disorders

Dexedrine Spansule Generic Name & Formulations

General Description

Dextroamphetamine sulfate 5mg, 10mg, 15mg; sust-rel caps.

Pharmacological Class

Amphetamine.

How Supplied

Caps—90

Manufacturer

Generic Availability

YES

Dexedrine Spansule Indications

Indications

Attention deficit hyperactivity disorder.

Dexedrine Spansule Dosage and Administration

Adult

Not recommended.

Children

Individualize. <6yrs: not recommended. ≥6yrs: initially 5mg 1–2 times daily; may increase by 5mg/day at weekly intervals; usual max 40mg/day.

Dexedrine Spansule Contraindications

Contraindications

Advanced arteriosclerosis. Symptomatic cardiovascular disease. Moderate-to-severe hypertension. Hyperthyroidism. Glaucoma. History of drug abuse. Agitation. During or within 14 days of MAOIs. Hypersensitivity to sympathomimetics.

Dexedrine Spansule Boxed Warnings

Boxed Warning

High abuse potential. Misuse may cause sudden death and serious cardiovascular events.

Dexedrine Spansule Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder; screen for risk before initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for new or worsening aggressive behavior or hostility. Seizure disorder. Monitor for serotonin syndrome; discontinue if occurs. Evaluate for tics or Tourette's syndrome prior to therapy. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers: not recommended.

Dexedrine Spansule Pharmacokinetics

See Literature

Dexedrine Spansule Interactions

Interactions

See Contraindications. Hypertensive crisis with MAOIs (including linezolid, IV methylene blue). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by urinary alkalinizers (eg, sodium bicarbonate, acetazolamide); avoid. Antagonized by acidifiers (eg, ascorbic acid), chlorpromazine, haloperidol, lithium. May potentiate TCAs, sympathomimetics, norepinephrine, meperidine. May antagonize adrenergic blockers, antihistamines, antihypertensives, veratrum alkaloids. May delay absorption of phenobarbital, phenytoin, ethosuximide. Convulsions with propoxyphene overdose and amphetamines. Monitor effects with concomitant PPIs. May interfere with urinary steroid test.

Dexedrine Spansule Adverse Reactions

Adverse Reactions

Palpitations, hypertension, tachycardia, CNS overstimulation, dizziness, insomnia, headache, motor and phonic tics, dry mouth, unpleasant taste, diarrhea, constipation, anorexia, urticaria, impotence, priapism; visual disturbances.

Dexedrine Spansule Clinical Trials

See Literature

Dexedrine Spansule Note

Not Applicable

Dexedrine Spansule Patient Counseling

See Literature

Dexedrine Spansule Generic Name & Formulations

General Description

Dextroamphetamine sulfate 5mg, 10mg, 15mg; sust-rel caps.

Pharmacological Class

Amphetamine.

How Supplied

Caps—90

Manufacturer

Generic Availability

YES

Dexedrine Spansule Indications

Indications

Narcolepsy.

Dexedrine Spansule Dosage and Administration

Adult

Individualize. 5–60mg daily in divided doses.

Children

Individualize. 6–12yrs: initially 5mg daily; may increase by 5mg/day at weekly intervals. ≥12yrs: initially 10mg daily; may increase by 10mg/day at weekly intervals.

Dexedrine Spansule Contraindications

Contraindications

Advanced arteriosclerosis. Symptomatic cardiovascular disease. Moderate-to-severe hypertension. Hyperthyroidism. Glaucoma. History of drug abuse. Agitation. During or within 14 days of MAOIs. Hypersensitivity to sympathomimetics.

Dexedrine Spansule Boxed Warnings

Boxed Warning

High abuse potential. Misuse may cause sudden death and serious cardiovascular events.

Dexedrine Spansule Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder; screen for risk before initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for new or worsening aggressive behavior or hostility. Seizure disorder. Monitor for serotonin syndrome; discontinue if occurs. Evaluate for tics or Tourette's syndrome prior to therapy. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers: not recommended.

Dexedrine Spansule Pharmacokinetics

See Literature

Dexedrine Spansule Interactions

Interactions

See Contraindications. Hypertensive crisis with MAOIs (including linezolid, IV methylene blue). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by urinary alkalinizers (eg, sodium bicarbonate, acetazolamide); avoid. Antagonized by acidifiers (eg, ascorbic acid), chlorpromazine, haloperidol, lithium. May potentiate TCAs, sympathomimetics, norepinephrine, meperidine. May antagonize adrenergic blockers, antihistamines, antihypertensives, veratrum alkaloids. May delay absorption of phenobarbital, phenytoin, ethosuximide. Convulsions with propoxyphene overdose and amphetamines. Monitor effects with concomitant PPIs. May interfere with urinary steroid test.

Dexedrine Spansule Adverse Reactions

Adverse Reactions

Palpitations, hypertension, tachycardia, CNS overstimulation, dizziness, insomnia, headache, motor and phonic tics, dry mouth, unpleasant taste, diarrhea, constipation, anorexia, urticaria, impotence, priapism; visual disturbances.

Dexedrine Spansule Clinical Trials

See Literature

Dexedrine Spansule Note

Not Applicable

Dexedrine Spansule Patient Counseling

See Literature