Dyanavel XR

(amphetamine ER)

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).