# Dexedrine Spansule ### (dextroamphetamine sulfate) **[Dexedrine Spansule](https://wiki.joshnp.com/books/drug-library/page/dexedrine-spansule)** (dextroamphetamine sulfate); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=cc717b9b-22ea-4c60-a1d4-ee38a40bce78&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cc717b9b-22ea-4c60-a1d4-ee38a40bce78)
--- ### **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](https://wiki.joshnp.com/link/34), and gives up the 3 to 5 year band. Single-isomer and later-peaking than [Adderall XR](https://wiki.joshnp.com/link/9) --- ### **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](https://wiki.joshnp.com/link/34), 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](https://wiki.joshnp.com/link/26) 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/