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Dyanavel XR

(amphetamine ER)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Tablets: 5 mg, 10 mg, 15 mg, and 20 mg
  • Liquid: 2.5 mg/mL (Total Bottle: 464 mL)

Dosing

  • Age: ≥ 6 y/o
  • Onset: ~60 min
  • Duration: up to 13 hours
  • Considerations: May be taken with or without food. Liquid and tablet formulations are interchangeable.
    • Tablet: The 5mg dose is scored to allow for accurate dosing down to 2.5mg.
    • Liquid: Bubblegum flavor
  • Initial Dose:
    • 6-12 y/o: 2.5-5 mg
    • 13+ y/o: 5-10 mg
  • Titration:
    • 6-12 y/o: 2.5 mg every 4-7 days
    • 13+ y/o: 5 mg every 4-7 days
  • Max Dose: 20 mg

Quick Facts

  • Increases synaptic dopamine and norepinephrine; improves focus, attention, and impulse control
  • Extended-release oral suspension; liquid formulation for ease of administration
  • Unique delivery system provides consistent, sustained symptom control
  • Common side effects: decreased appetite, insomnia, increased heart rate, elevated blood pressure

Indications

  •  ADHD (ICD-10: F90.0)

Off-Label Uses

  • N/A 

How to Take

  • Take once daily in the morning to reduce the risk of insomnia.
  • Can be taken with or without food.
  • Shake the suspension well before each dose to ensure even distribution.
  • Measure dose accurately using a provided oral syringe or dosing cup—do not use household spoons.

Side Effects

  •  

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 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).