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Zenzedi

(dextroamphetamine sulfate)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Tablets: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg 

Dosing

  • Age: ≥ 3 y/o
  • Onset: ~ 30-60 minutes
  • Duration: 4-6 hours
  • Considerations: Take the first dose on awakening. Additional doses may be given at intervals of 4-6 hours. Periodic drug holidays are recommended to assess the patient’s condition.
  • Initial Dose:
    • 3-5 y/o: 2.5 mg daily
    • 6+ y/o: 5 mg once or twice daily
  • Titration:
    • 3-5 y/o: 2.5 mg weekly
    • 6+ y/o: 5 mg weekly
  • Max Dose:
    • 3-5 y/o: 20 mg/day
    • 6+ y/o:
      • ≤50 kg: 40 mg/day
      • >50 kg: 60 mg/day 

Quick Facts

  • Increases synaptic dopamine and norepinephrine by enhancing presynaptic release and inhibiting reuptake
  • Enhances focus, attention, and impulse control
  • Immediate-release formulation for rapid onset
  • Contains dextroamphetamine sulfate as the active ingredient
  • Common side effects: decreased appetite, insomnia, increased heart rate, headache, dry mouth 

Indications

  •  ADHD (ICD-10: F90.0)
  • Narcolepsy (ICD-10: G47.419)

Off-Label Uses

  •  N/A

How to Take

  • Take once or multiple times daily, as directed.
  • Can be taken with or without food; high-fat meals may delay absorption.
  • Swallow the tablet whole; do not crush, chew, or split.
  • Avoid taking late in the day to prevent insomnia.

Side Effects

  • Common: Insomnia, decreased appetite, weight loss, dry mouth, headache
  • Serious: Cardiovascular events, psychiatric symptoms (e.g., psychosis, mania), growth suppression in children, peripheral vasculopathy (including Raynaud's phenomenon)

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, shortness of breath (cardiovascular concerns).
    • Uncontrolled movements, tics, or worsening anxiety.
    • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
    • Unexplained weight loss or delayed growth in pediatric patients.

  • Safety Tips:

    • Monitor blood pressure and heart rate, 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.

  • Parent Tips for Pediatric Patients:

    • Encourage a nutrient-dense diet to counteract appetite suppression.
    • Administer in the morning before school for optimal effect.
    • Monitor school performance and behavioral changes.
    • Observe for sleep disturbances; adjust timing if necessary.
    • Communicate regularly with teachers and caregivers about medication effects.

Additional Information

  • Contraindications:

    • Hypersensitivity to dextroamphetamine 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 dextroamphetamine levels.
    • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists)

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