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Mydayis

(dextroamphetamine-amphetamine ER)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Capsules: 12.5 mg, 25 mg, 37.5 mg, and 50 mg

Dosing

  • Age: ≥ 13 y/o
  • Onset: Approximately 1-2 hours
  • Duration: Up to 16 hours
  • Considerations: Capsules may be swallowed whole or sprinkled on cold applesauce and consumed immediately without chewing. Administer once daily upon awakening to avoid insomnia. Consistency with or without food is recommended. Do not substitute for other amphetamine products on a milligram-per-milligram basis.
  • Initial Dose: 12.5 mg once daily in the morning
  • Titration: 12.5 mg weekly
  • Max Dose:
    • 13-17 y/o: 25 mg/day
    • Adults: 50 mg/day

Quick Facts

  • Combination of immediate- and two delayed-release beads for extended duration.
  • Increases synaptic dopamine and norepinephrine via amphetamine salts; enhances focus, attention, and impulse control
  • Extended-release capsule with multi-phase release (initial, intermediate, extended) for prolonged symptom control
  • Once-daily dosing providing coverage for up to 16 hours
  • Common side effects: decreased appetite, insomnia, headache, dry mouth, increased heart rate 

Indications

  •  ADHD (ICD-10: F90.0)

Off-Label Uses

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How to Take

  • Take once daily in the morning to minimize the risk of insomnia.
  • Can be taken with or without food; high-fat meals may delay absorption.
  • Swallow the capsule whole; do not crush, chew, or split.
  • If needed, the capsule may be opened, and contents sprinkled on applesauce—consume immediately without chewing.

Side Effects

  • Common: Insomnia, decreased appetite, weight loss, dry mouth, increased heart rate, anxiety.
  • Serious: Cardiovascular events, psychiatric symptoms, growth suppression, peripheral vasculopathy, seizures, serotonin syndrome.

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).