Dextroamphetamine IR tablets
ZENZEDI
Pronunciation: dex-troe-am-FET-a-meen (zen-ZED-ee)
“Dexter amphetamine”
What it isDextroamphetamine IR tablets (ZENZEDI, 2013) — Seven strengths, 2.5-30 mg.
Why this oneDuration of action 3-5 h (Carlat Table 1); same molecule and elimination kinetics as the parent — the formulation is the difference.
What limits itApproved ages (ADHD label): 3-16. Class warnings of the parent molecule apply.
FDA-approved for
- ADHD (2013)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Narcolepsy | Adults and pediatric ≥6 y | 5 mg/day (6–12 y) or 10 mg/day (≥12 y) | 5–60 mg/day in divided doses | 60 mg/day |
| Attention Deficit Disorder with Hyperactivity | Pediatric 3–16 y | 2.5 mg/day (3–5 y) or 5 mg QD–BID (≥6 y) | 40 mg/day |
Titration Increase in weekly increments (2.5 mg for 3–5 y; 5 mg for ≥6 y / 6–12 y narcolepsy; 10 mg for ≥12 y narcolepsy)
Renal Undefined
Hepatic Undefined
Instructions
- Use lowest effective dosage; give first dose on awakening
- Avoid late evening doses (insomnia)
- Give additional doses (1 or 2) at 4–6 h intervals
Available strengths
- tab 2.5, 5, 7.5, 10, 15, 20, 30 mg
- ER cap 5, 10, 15 mg
- sol 5 mg/5 mL
- patch 4.5, 9, 13.5, 18 mg/9 hr
Contraindications
- During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result)
Cautions
- Serious cardiac disease/sudden death
- Increased blood pressure and heart rate
- Psychiatric adverse reactions (psychosis/mania)
- Long-term growth suppression in pediatrics
- Seizures (lowered threshold)
- Peripheral vasculopathy incl. Raynaud's phenomenon
- Serotonin syndrome
- Motor/verbal tics, worsening of Tourette's
Adverse reactions
- Palpitations
- Tachycardia
- Elevated blood pressure
- Overstimulation/restlessness
- Insomnia
- Dizziness
- Dyskinesia
- Tremor
- Headache
- Dry mouth
- Diarrhea/constipation
- Anorexia/weight loss
Pregnancy Pregnancy Category C; use only if potential benefit justifies risk to fetus
Lactation Amphetamines are excreted in human milk; mothers should refrain from nursing
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 2.5 mg | tab | per unit | $3.95/ea | not offered |
| 5 mg | tab | per unit | $0.38/ea | not offered |
| 7.5 mg | tab | per unit | $5.83/ea | not offered |
| 10 mg | tab | per unit | $0.37/ea | not offered |
| 15 mg | tab | per unit | $5.45/ea | not offered |
| 20 mg | tab | per unit | $5.41/ea | not offered |
| 30 mg | tab | per unit | $5.49/ea | not offered |
Other forms: Dextro amphetamine (DEXEDRINE) · Dextroamphetamine patch (XELSTRYM) · Dextroamphetamine spansule (DEXEDRINE SPANSULE) · Dextroamphetamine oral solution (PROCENTRA)
Available combined with: Amphetamine (ADDERALL) · Amphetamine XR suspension (DYANAVEL XR) · Mixed amphetamine salts (triple-bead) (MYDAYIS) · Mixed amphetamine salts XR (ADDERALL XR)
⚠ BOXED WARNING
- Abuse, misuse and addiction
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityMisuse, hypertension, hyperthermia, psychosis and potentially fatal sympathomimetic toxicity.
Serotonin and MAOI
Provisional washout figures
Elevating mechanismNone identified
Non-elevating actionNone recorded
Exposure dependenceNo serotonin-elevating mechanism identified
Evidence confidenceModerate
InterpretationNo clinically meaningful serotonin-elevating mechanism identified in this first-pass Gillman-based review.
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