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DEXEDRINE SPANSULE
ADHD
Sleep-wake disorders
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Drug Name:

DEXEDRINE SPANSULE CII

Generic Name and Formulations:
Dextroamphetamine sulfate 5mg, 10mg, 15mg; sust-rel caps.

Company:
Amedra Pharmaceuticals

Therapeutic Use:

Indications for DEXEDRINE SPANSULE:

Attention deficit hyperactivity disorder.

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.

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.

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.

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, busprione, 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.

Pharmacological Class:

Amphetamine.

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.

Generic Availability:

YES

How Supplied:

Caps—90

Indications for DEXEDRINE SPANSULE:

Narcolepsy.

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.

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.

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.

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, busprione, 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.

Pharmacological Class:

Amphetamine.

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.

Generic Availability:

YES

How Supplied:

Caps—90

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