Adzenys XR-ODT

(amphetamine extended-release orally disintegrating tablet)

Forms/Strengths

•  Orally Disintegrating Tablets: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30 min
• Duration: ~12 hours
• Release Profile: 50% IR, 50% ER
• Considerations: Orange-flavored. May be taken with or without food. Allow tablet to disintegrate in saliva before swallowing.
  • Adderall XR Equivalent Doses
• Initial Dose:
  • 6-17 y/o: 6.3 mg
    
  • 18+ y/o: 12.5 mg
• Titration: 3.1 mg - 6.3 mg weekly
• Max Dose:
  • 6-12 y/o: 18.8 mg/day
  • 13+ y/o: 12.5 mg/day

Important Note: To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis due to different amphetamine base compositions and pharmacokinetic profiles.

Quick Facts

• Mixed amphetamine salts (75% dextroamphetamine base, 25% levoamphetamine base); increases synaptic norepinephrine and dopamine via enhanced release and reuptake inhibition
• Dual-release profile (50% immediate, 50% extended) for rapid onset and all-day coverage in ADHD
• Improves core ADHD symptoms: inattention, hyperactivity, impulsivity
• Black box warning: High potential for abuse, misuse, addiction, overdose, and death; Schedule II controlled substance
• Unique ODT formulation dissolves on tongue without water; orange flavor improves palatability
• Common effects: appetite suppression, insomnia, ↑BP/HR; monitor growth in children
• Not interchangeable with other amphetamines on mg basis due to base equivalence differences
  

Indications

•  Attention Deficit Hyperactivity Disorder (ADHD) (ICD-10: F90.0)

Off-Label Uses

•  Narcolepsy (ICD-10: G47.411): Occasionally used off-label, though not FDA-approved for this indication.

How to Take

• Take once daily in the morning to reduce the risk of insomnia.
• Do not crush, chew, or split the tablet.
• Place the orally disintegrating tablet (ODT) on the tongue and allow it to dissolve completely; do not swallow whole.
• Can be taken with or without food.
  

Side Effects

• Common:
  • CNS: insomnia, headache, anxiety, irritability, dizziness
  • GI: decreased appetite, weight loss, dry mouth, nausea, abdominal pain
  • CV: ↑heart rate, ↑blood pressure
  • Other: asthenia (fatigue)
• Serious:
  • Black box: Abuse/misuse/addiction leading to overdose/death
  • CV: sudden death, myocardial infarction, stroke, arrhythmias (esp. with structural heart defects)
  • Psych: new/exacerbated psychosis, mania, aggression, hallucinations
  • Peripheral vasculopathy: Raynaud's-like symptoms (pain, numbness, color change in fingers/toes)
  • Serotonin syndrome (with serotonergics): hyperthermia, rigidity, seizures
  • Growth suppression in children
    

Monitoring / Labs

• Baseline/periodic: BP, HR, weight, height (pediatrics), BMI
• Assess growth every 3-6 months in children; plot on charts
• Monitor for psychiatric changes, tics, substance misuse
• LFTs, CBC if long-term or symptoms (e.g., dark urine)
• ECG if cardiac history

Education

• When to Call the Doctor:

  • Chest pain, palpitations, shortness of breath, fainting
  • Severe anxiety, hallucinations, mood changes, suicidal thoughts
  • Finger/toe pain, numbness, color changes (cold/pale/blue)
  • Prolonged erection (>4 hours), uncontrolled tics/movements
  • Signs of overdose: agitation, hallucinations, hyperthermia, seizures

• Safety Tips:

  • Take only as prescribed; store securely (controlled substance)
  • Avoid alcohol, caffeine, OTC decongestants (↑CV effects)
  • Report all meds/supplements to avoid interactions
  • No driving/operating machinery until effects known

  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Give before school to minimize sleep interference
  • Use pill organizer or reminders; track appetite/weight weekly
  • Partner with school (teacher reports on focus/behavior)
  • Promote healthy meals/snacks despite appetite loss
  • Watch for growth delays; annual pediatrician review

Additional Information

• Contraindications:

  • Known hypersensitivity to amphetamines
  • MAOI use within 14 days (hypertensive crisis)
  • Advanced arteriosclerosis, symptomatic heart disease, moderate-severe HTN, hyperthyroidism, glaucoma
  • History of drug abuse
  • Pregnancy: Category C; potential fetal harm (↓birth weight, withdrawal); use only if benefit > risk (APLENZIN registry)
  • Lactation: Excreted in milk; avoid or discontinue nursing
  • Drug Interactions:
    • CYP2D6 inhibitors (e.g., bupropion, fluoxetine): ↑amphetamine levels
    • MAOIs/serotonergics: serotonin syndrome, hypertensive crisis
    • Acidifiers (vit C): ↓absorption; alkalinizers (NaHCO3): ↑levels
    • Pressors (decongestants): additive HTN/tachycardia

References

1. Amphetamine XR-ODT Prescribing Information, Aytu BioPharma, 2023, https://www.fffenterprises.com/assets/downloads/product-information/aytu-biopharma/pi-AMPHETAMINE-XR-ODT.pdf
2. DailyMed: Amphetamine extended-release orally disintegrating tablets, 2023, https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=48d0f55c-f847-4d26-b2ed-94b5a2770228