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Adzenys XR-ODT

(amphetamine extended-release orally disintegrating tablet)

Full Prescribing Information DailyMed Drug Information

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.
  • 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

Equivalent Doses of ADZENYS XR-ODT and ADDERALL XR
ADZENYS XR-ODT
 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.7 mg 18.8 mg
ADDERALL XR
 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg

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

       

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