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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

  • Increases synaptic norepinephrine/dopamine via enhanced presynaptic release and reuptake inhibition
  • Improves focus, attention, impulse control
  • Common side effects: decreased appetite, insomnia, elevated blood pressure
  • Extended-release ODT with dual-phase (immediate and delayed) release for rapid onset and sustained effect
  • Unique ODT formulation that disintegrates on the tongue without water

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:
    • Insomnia, irritability, anxiety
    • Decreased appetite, weight loss
    • Dry mouth, nausea, abdominal pain
    • Increased blood pressure, heart rate
  • Serious:
    • Rare cardiovascular events (arrhythmias, sudden death in at-risk populations)
    • Psychiatric effects: mania, aggression, or psychosis

Monitoring / Labs

  • Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.

  • Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.

  • Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.

  • Abuse Potential: Monitor for misuse or diversion.

Education

  • When to Call the Doctor

    • Severe mood changes, aggression, or suicidal thoughts.

    • Chest pain, rapid heartbeat, or shortness of breath.

    • Uncontrolled movements, tics, or worsening anxiety.

    • Numbness, coldness, or color changes in fingers or toes.

    • Signs of serotonin syndrome, such as agitation, rapid heartbeat, or tremors.

  • Safety Tips:

    • Monitor blood pressure and heart rate regularly, especially in patients with cardiovascular risk.

    • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.

    • Avoid caffeine and other stimulants, which may amplify side effects.

    • Ensure adequate hydration and nutrition, as appetite suppression is common.

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

  • Tips for Pediatric Patients:

    • Encourage a balanced diet to counteract appetite suppression.

    • Monitor school performance and behavioral changes.

    • Administer in the morning before school for optimal effect.

    • Observe for sleep disturbances and adjust timing if necessary.

    • Communicate with teachers and caregivers about medication effects.

    Additional Information

    • Contraindications:

      • Hypersensitivity to amphetamines or formulation components.
      • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
      • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
      • History of substance use disorder, unless benefits outweigh risks.

    • Pregnancy:

      • Category C; use only if benefits outweigh risks.
      • May cause neonatal withdrawal symptoms or low birth weight.

    • Lactation:

      • Excreted in breast milk; not recommended due to potential infant exposure.

    • Drug Interactions:

      • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
      • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
      • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
      • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).
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