Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Dexedrine Spansule Generic Name & Formulations
Legal Class
CII
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
Legal Class
CII
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
