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Dexedrine Spansule

(dextroamphetamine sulfate)

Dexedrine Spansule (dextroamphetamine sulfate); CII

Full Prescribing Information DailyMed Drug Information

Summary

Dexedrine Spansule is a sustained-release dextroamphetamine capsule approved for narcolepsy and for ADHD in patients aged 6 to 16. It is single-isomer dextroamphetamine, so it carries no levoamphetamine and less peripheral noradrenergic load than Adderall XR at an equivalent dose. Its role is once-daily dextroamphetamine where the immediate-release tablet would need two or three doses; the label is candid that the pellet is only more convenient, not more effective. Schedule II; brand and generic.

Forms & Strengths

  • Sustained-release capsules (Spansule): 5 mg, 10 mg, 15 mg

Dosing

  • Age:
    • ADHD: 6-16 y/o, the label's own upper bound. Not recommended below 6 years
    • Narcolepsy: no age bound stated; the label gives a dose ladder from age 6
  • Onset: 30-60 min, from the promptly released initial fraction
  • Duration: 6 to 8 hours
  • Release Profile: Sustained-release pellets; an initial dose released promptly, the remainder gradually. Tmax about 8 hours against about 3 hours for the tablet
  • Initial Dose:
    • ADHD, 6-16 y/o: 5 mg once or twice daily
    • Narcolepsy, 6-11 y/o: 5 mg daily
    • Narcolepsy, ≥ 12 y/o: 10 mg daily
  • Titration:
    • ADHD, 6-16 y/o: 5 mg at weekly intervals
    • Narcolepsy, 6-11 y/o: 5 mg at weekly intervals
    • Narcolepsy, ≥ 12 y/o: 10 mg at weekly intervals
  • Max Dose:
    • ADHD: 40 mg/day; only in rare cases will it be necessary to exceed this
    • Narcolepsy: usual range 5-60 mg/day in divided doses
  • Considerations: Use once daily where appropriate; the same total dose of immediate release in divided doses is equally effective by this label. Avoid late evening doses.

Pharmacology

  • Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
  • Delivery / Release: Lower peak than the tablet (Cmax 23.5 vs 36.6 ng/mL at 15 mg), same bioavailability
  • Formulation: Single-isomer dextroamphetamine sulfate; no levoamphetamine, the difference from the 3:1 mixed-salt products
  • Metabolism: CYP2D6 to 4-hydroxyamphetamine, with minor CYP2D6 inhibition. Half-life about 12 hours. Renal excretion is pH dependent
  • Pharmacogenomics: No genotype-directed dosing in the label; the actionable consequence is the CYP2D6-inhibitor interaction
  • Class Positioning: Buys once-daily dosing and a lower peak over Zenzedi, and gives up the 3 to 5 year band. Single-isomer and later-peaking than Adderall XR

Indications

  • Narcolepsy (ICD-10: G47.419): no age bound stated; dosing from age 6
  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 16 y/o, within a total treatment program

Off-Label Uses

  • ADHD at 17 and older (ICD-10: F90.x): this label stops at 16. Supported by the broader amphetamine literature; switch to a product with an adult indication.
  • ADHD under 6 years (ICD-10: F90.x): insufficient. Zenzedi, the same moiety, is approved from age 3, so the floor is formulation-specific. AAP: behavioral intervention first-line (AAP 2019).
  • Binge eating disorder (ICD-10: F50.81): lisdexamfetamine holds it, adults only; insufficient here.
  • Where the evidence does not support use: depression augmentation; no pediatric evidence for sustained-release dextroamphetamine (AHRQ 2024).
  • Cognitive enhancement without ADHD: not an indication; not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse, and addiction; risk of overdose and death, rising with higher doses and non-oral routes. Assess abuse risk and monitor throughout.
  • Contraindicated:
    • Known hypersensitivity to amphetamine or any component
    • MAOI use, current or within 14 days
  • Use with caution (label Warnings, not contraindications):
    • Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; the label says avoid
    • Pre-existing hypertension; expect mean rises of 2-4 mmHg and 3-6 bpm
    • Psychosis or bipolar disorder; in psychotic children, worsened behaviour disturbance and thought disorder
    • Prior seizure or EEG abnormality
    • Peripheral vasculopathy including Raynaud phenomenon
    • Tics or Tourette syndrome, personal or family
    • Substance use disorder, patient or household
    • Symptoms secondary to environmental factors or another psychiatric disorder
  • Screen before starting:
    • Cardiac and family history of sudden death or ventricular arrhythmia; ECG only if positive
    • Tics and Tourette syndrome, in child and family; this label makes that a precondition
    • Mania risk factors, including family history of suicide or bipolar disorder
    • Abuse and diversion risk
    • Baseline height, weight, blood pressure and heart rate

Drug Interactions

  • MAOIs (selegiline, tranylcypromine, phenelzine, linezolid, methylene blue): hypertensive crisis; do not give within 14 days.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone): serotonin syndrome; counsel on symptoms and stop both if it occurs.
  • CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure; start lower.
  • Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels; the label says avoid.
  • Acidifying agents (ascorbic acid, methenamine salts): lower levels; adjust on response.
  • Tricyclics (desipramine, protriptyline): sustained rise in brain d-amphetamine; monitor and adjust.
  • Antiepileptics (phenytoin, phenobarbital, ethosuximide): delayed absorption; separate dosing and check levels after any stimulant change.
  • Antihypertensives: hypotensive effect antagonised; recheck blood pressure after starting the stimulant.
  • Antihistamines: sedative effect counteracted; do not rely on one for sleep.

Administration

  • Give the first dose on waking; may be used once daily wherever appropriate.
  • For narcolepsy the label's usual dose is divided; the Spansule may replace those divisions.
  • Avoid late evening doses.
  • Swallow whole. This label carries no instruction to open, sprinkle, crush or chew, and no data for doing so, unlike its mixed-salt siblings.
  • If the child cannot swallow a capsule, switch to an IR tablet or ProCentra oral solution.
  • Food does not matter; absorption is similar fed and fasted.
  • The label directs prescribing the least quantity feasible at one time.
  • If a dose is missed, skip it; do not double up.
  • Store securely, preferably locked.

Side Effects

  • Common: loss of appetite, weight loss, insomnia, overstimulation, restlessness, dry mouth, headache, dizziness, tremor, dysphoria, diarrhoea, constipation, palpitations, raised blood pressure
  • Serious:
    • Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
    • Psychotic episodes at recommended doses (rare), mania and new aggression. Consider discontinuing.
    • Serotonin syndrome. Stop both drugs and treat supportively.
    • Seizures. Discontinue.
    • Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
    • Growth suppression. Interrupt if height or weight gain falls behind.
    • New or worsening motor and verbal tics. Discontinue if clinically appropriate.
    • Cardiomyopathy with chronic use, rhabdomyolysis, intestinal ischaemia.
    • Prolonged erections; painful erection beyond a few hours is a surgical emergency.

Monitoring & Labs

  • Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months.
  • Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if two major percentile lines are crossed.
  • Appetite and Sleep: at every visit and dose change; ask what time the child eats and falls asleep.
  • Psychiatric and tics: psychosis, mania, aggression, dysphoria and new tics at every visit.
  • Peripheral vasculopathy: inspect fingers and toes at every visit.
  • Abuse and Diversion: adherence, pill counts and PDMP check at every refill; set quantity limits per this label's least-quantity instruction.
  • Age boundary: review the indication at the 17th birthday.
  • Laboratory: none routinely.

Discontinuation & Taper

  • May be stopped abruptly at therapeutic doses; no taper is required.
  • Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
  • Rebound irritability and hunger arrive later than with the IR tablet; families describe a difficult evening.
  • Interrupt treatment where growth or weight gain falls behind.
  • Drug holidays are reasonable where appetite or growth suppression is limiting; unlike Zenzedi, this label does not itself recommend periodic interruption.

Pregnancy & Lactation

  • Pregnancy: No adequate controlled studies; animal teratogenicity only far above human doses. Amphetamine-dependent mothers have more premature delivery and low birth weight. Use only if benefit justifies fetal risk.
  • Lactation: Label advises against nursing. LactMed: infant dose about 5.7% of the maternal weight-adjusted dose, infant plasma 6 to 14% of maternal, all four infants studied growing normally. (LactMed 2025)
  • Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2025)
  • Exposure Registry: None on this label; the National Pregnancy Registry for Psychostimulants (1-866-961-2388) accepts amphetamine exposures.

Counseling Points

  • Counsel the family on:

    • Swallowing the capsule whole; unlike the mixed-salt capsules there is no sprinkle instruction.
    • Telling you if the child cannot swallow it, so the product changes rather than being improvised.
    • The capsule being a convenience, not an upgrade; divided immediate release works as well.
    • The later peak, around eight hours, so the hard stretch is often evening rather than mid-afternoon.
    • Vitamin C mimicking treatment failure; bicarbonate and antacids raising levels.
    • On phenytoin, phenobarbital or ethosuximide, a level check after a stimulant change is expected.
    • Moving the largest meal to breakfast and evening, with a weight check each visit.
    • The ADHD approval running to age 16; plan before the 17th birthday.
    • Locked storage; the prescription is deliberately written in the smallest workable quantity.

  • Advise them to call for:

    • Chest pain on exertion, fainting, or a racing heart that does not settle.
    • New hallucinations, or new suspicious or fearful thinking.
    • Numbness, coldness or colour change in the fingers or toes.
    • A new or markedly worse tic, or a seizure of any kind.
    • Severe muscle pain with dark urine after exertion.
    • Weight loss, or clothes fitting more loosely over a few weeks.
    • A painful erection lasting more than a few hours, which is a surgical emergency.
    • Agitation, shivering, sweating or confusion after an antidepressant change.

References

  1. DailyMed. DEXEDRINE SPANSULE (dextroamphetamine sulfate) sustained-release capsules prescribing information. Amneal Pharmaceuticals LLC. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cc717b9b-22ea-4c60-a1d4-ee38a40bce78
  2. LactMed. Dextroamphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/
  3. openFDA. NDC Directory, generic_name "dextroamphetamine". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
  4. American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis
  5. Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
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