Amphetamine XR-ODT
ADZENYS XR-ODT
What it isExtended-release amphetamine (ADZENYS XR-ODT, 2016) that releases norepinephrine, dopamine, and serotonin; ADHD.
Why this oneThe orally disintegrating tablet needs no water and uses 50% IR / 50% ER; 3.1 mg = 5 mg mixed salts, with 8-12 h (Carlat Table 1) of action.
What limits itAppetite loss, insomnia, cardiovascular stimulation, and abuse risk remain those of amphetamine.
FDA-approved for
- ADHD (2016)
FDA label
Read the full label on DailyMed ↗
BOXED WARNING High potential for abuse, misuse, and addiction; can lead to overdose and death.
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| ADHD | Adults | 12.5 mg QAM | ||
| ADHD | Peds 6–12 yr | 6.3 mg QAM; titrate 3.1–6.3 mg/wk | 18.8 mg/day | |
| ADHD | Peds 13–17 yr | 6.3 mg QAM; titrate 3.1–6.3 mg/wk | 12.5 mg/day |
Titration Titrate at weekly intervals
Renal Undefined
Hepatic Undefined
Instructions
- Give in the morning, with or without food
- Place whole tablet on tongue; allow to disintegrate then swallow (no chewing/crushing)
- Do not substitute mg-per-mg for other amphetamine products
Contraindications
- Concurrent MAOIs or use within 14 days (incl. linezolid, IV methylene blue) — risk of hypertensive crisis
Cautions
- Serious cardiac events with structural cardiac abnormalities
- Increased blood pressure/heart rate
- Psychiatric adverse reactions
- Long-term growth suppression in children
- Peripheral vasculopathy (Raynaud's)
- Serotonin syndrome
- Tics/Tourette's worsening
Adverse reactions
- Loss of appetite, insomnia
- Dry mouth, weight loss
- Abdominal pain, nausea
- Anxiety, agitation, dizziness
- Tachycardia
Pregnancy May cause premature delivery and low birth weight; monitor neonates for withdrawal.
Lactation Breastfeeding not recommended (amphetamine present in milk).
⚠ BOXED WARNING
- Abuse, misuse and addiction
Classes and tags
Clinical profile
Mechanism of action: Amphetamine XR-ODT ballicule
Open Amphetamine XR-ODT in the interactive console ↗
Memory aids: mascots and interaction avatars
