Amphetamine XR-ODT
ADZENYS XR-ODT
“Zen Amp”
What it isExtended-release amphetamine (ADZENYS XR-ODT, 2016) that releases norepinephrine, dopamine, and serotonin; ADHD.
Why this oneOrally 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)
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityMisuse, hypertension, hyperthermia, psychosis and potentially fatal sympathomimetic toxicity.
FDA label
Read the full label on DailyMed ↗
| 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
Available strengths
- ODT 3.1, 6.3, 9.4, 12.5, 15.7, 18.8 mg
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).
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 3.1 mg | ODT | 30 qd | $475.25 | not offered |
| 6.3 mg | ODT | 30 qd | $482.20 | not offered |
| 9.4 mg | ODT | 30 qd | $486.53 | not offered |
| 12.5 mg | ODT | 30 qd | $478.87 | not offered |
| 15.7 mg | ODT | 30 qd | $477.87 | not offered |
| 18.8 mg | ODT | 30 qd | $468.43 | not offered |
Other forms: Amphetamine racemic (1:1) (EVEKEO)
Available combined with: Amphetamine (ADDERALL) · Amphetamine XR suspension (DYANAVEL XR) · Mixed amphetamine salts (triple-bead) (MYDAYIS) · Mixed amphetamine salts XR (ADDERALL XR)
Serotonin and MAOI
Provisional washout figures
Elevating mechanismNone identified
Exposure dependenceNo serotonin-elevating mechanism identified
Evidence confidenceModerate
InterpretationNo clinically meaningful serotonin-elevating mechanism identified in this first-pass Gillman-based review.
Open Amphetamine XR-ODT in the interactive console ↗
Memory aids: interaction avatars
Open Amphetamine XR-ODT in the interactive console ↗
Self-check
- How much mixed amphetamine salt corresponds to ADZENYS XR-ODT 3.1 mg?
5 mg. - Does ADZENYS XR-ODT need water?
No.