Dexedrine Spansule

— THERAPEUTIC CATEGORIES —
  • ADHD
  • Sleep-wake disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Amneal Pharmaceuticals

    Generic Availability

    YES

    Mechanism of Action

    Amphetamines are noncatecholamine, sympathomimetic amines with central nervous system (CNS) stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. Dexedrine spansule capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard formulation, as demonstrated by blood levels.

    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

    During or within 14 days of MAOIs. 

    Dexedrine Spansule Boxed Warnings

    Boxed Warning

    Abuse, misuse, and addiction.

    Dexedrine Spansule Warnings/Precautions

    Warnings/Precautions

    High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode before initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for seizures, serotonin syndrome; discontinue if occurs. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

    Dexedrine Spansule Pharmacokinetics

    Absorption

    Maximal plasma concentration: 23.5 ng/mL at ~8 hours after dosing (one 15mg SR cap).

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: ~12 hours.

    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

    Amneal Pharmaceuticals

    Generic Availability

    YES

    Mechanism of Action

    Amphetamines are noncatecholamine, sympathomimetic amines with central nervous system (CNS) stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. Dexedrine spansule capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard formulation, as demonstrated by blood levels.

    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

    During or within 14 days of MAOIs. 

    Dexedrine Spansule Boxed Warnings

    Boxed Warning

    Abuse, misuse, and addiction.

    Dexedrine Spansule Warnings/Precautions

    Warnings/Precautions

    High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode before initiation. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for seizures, serotonin syndrome; discontinue if occurs. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

    Dexedrine Spansule Pharmacokinetics

    Absorption

    Maximal plasma concentration: 23.5 ng/mL at ~8 hours after dosing (one 15mg SR cap).

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: ~12 hours.

    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

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