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

• 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).