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
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
LactMed. Dextroamphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/
openFDA. NDC Directory, generic_name "dextroamphetamine". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
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
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/