Dextroamphetamine spansule
DEXEDRINE SPANSULE
What it isExtended-release dopamine-releasing amphetamine stimulant; ADHD.
Why this oneWith 50% IR / 50% sustained-release beads, it extends the active d-enantiomer; Duration of action 6-8 h (Carlat Table 1).
What limits itAppetite loss, insomnia, and blood-pressure elevation can limit use. Schedule II; misuse and dependence remain concerns.
FDA-approved for
- ADHD (1976)
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Narcolepsy | Adults and children (6-11 yr start 5 mg QD; ≥12 yr start 10 mg QD) | 10 mg/day (≥12 yr); 5 mg/day (6-11 yr) | raise weekly (5 mg for 6-11 yr; 10 mg for ≥12 yr) to optimal response | up to 60 mg/day (usual 5-60 mg/day divided) |
| ADHD | Pediatric 6-16 yr | 5 mg once or twice daily | raise weekly by 5 mg to optimal response | rarely exceed 40 mg/day |
Titration Raise dose in 5 mg (ADHD; narcolepsy 6-11 yr) or 10 mg (narcolepsy ≥12 yr) increments at weekly intervals
Renal Undefined
Hepatic Undefined
Instructions
- Administer at lowest effective dosage; individualize
- Avoid late evening doses (insomnia)
- Spansule capsules may be used for once-a-day dosing where appropriate
Contraindications
- MAOIs, or within 14 days of stopping an MAOI (including linezolid or IV methylene blue), due to risk of hypertensive crisis
Cautions
- Serious cardiac disease — avoid (sudden death)
- Increased blood pressure and heart rate — monitor
- Psychiatric adverse reactions; screen for bipolar risk
- Long-term growth suppression in pediatric patients
- Seizures (may lower convulsive threshold)
- Peripheral vasculopathy, including Raynaud's phenomenon
- Serotonin syndrome with serotonergic drugs/CYP2D6 inhibitors
- Motor/verbal tics and worsening of Tourette's
Adverse reactions
- Palpitations, tachycardia, elevated blood pressure
- Overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, tics
- Dry mouth, unpleasant taste, diarrhea, constipation, anorexia and weight loss
- Impotence, changes in libido
Pregnancy Embryotoxic/teratogenic in mice at high multiples of human dose; use only if potential benefit justifies risk; infants of dependent mothers at risk of prematurity, low birth weight, withdrawal
Lactation Amphetamines are excreted in human milk; mothers should refrain from nursing
⚠ BOXED WARNING
- Abuse, misuse and addiction
Classes and tags
Clinical profile
Mechanism of action: Dextroamphetamine spansule ballicule
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