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Adderall

(amphetamine/dextroamphetamine immediate-release)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  •  Tablets: 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg
  • These are mixed amphetamine salts (MAS) in a 3:1 ratio of dextroamphetamine to levoamphetamine salts for balanced effects on focus (dextro) and alertness (levo).

Dosing

  • Age: ≥ 3 y/o
  • Onset: 30-60 minutes
  • Duration: 4-6 hours
  • Considerations: Administer first dose upon awakening; additional doses at 4-6 hour intervals; may take with or without food (high-fat meals may delay absorption)
  • Initial Dose:
    • 3-5 y/o: 2.5 mg daily
    • 6+ y/o: 5 mg 1-2 times daily
  • Titration:
    • 3-5 y/o: 2.5 mg weekly
    • 6+ y/o: 5 mg weekly
  • Max Dose:
    • ≤50 kg: 40 mg/day
    • >50 kg: 60 mg/day (Narcolepsy)

Quick Facts

  • Increases synaptic dopamine and norepinephrine via presynaptic release, reuptake inhibition (DAT/NET), and VMAT2-mediated vesicular efflux
  • Enhances focus, attention, impulse control, and wakefulness in ADHD and narcolepsy
  • Common side effects: decreased appetite, insomnia, dry mouth, weight loss, increased heart rate/blood pressure
  • Schedule II controlled substance with high abuse/misuse potential
  • Black box warning: Abuse and dependence; sudden death and serious cardiovascular events reported
  • May suppress growth in pediatrics; monitor height/weight
  • 3:1 dextro:levo ratio balances cognitive focus (dextro) and peripheral alerting effects (levo)

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9)
  • Narcolepsy (ICD-10: G47.419)

Off-Label Uses

  • Treatment-resistant depression (ICD-10: F33.9): Adjunctive for low-energy symptoms
  • Cognitive enhancement post-TBI (ICD-10: S06.0-S06.9): Improves attention and processing speed
  • Augmentation in bipolar depression (ICD-10: F31.4): Short-term for anhedonia

How to Take

  • Administer once or multiple times daily, as directed.
  • Take with or without food; high-fat meals may delay absorption.
  • If using the tablet, swallow whole; do not crush, chew, or split unless scored.
  • Avoid dosing late in the day to prevent insomnia.

Side Effects

  • Common:
    • Cardiovascular: Tachycardia, hypertension, palpitations
    • CNS: Insomnia, headache, irritability, anxiety, dizziness
    • GI: Dry mouth, anorexia, weight loss, abdominal pain
    • Other: Decreased appetite, euphoria
  • Serious:
    • Black box: Risk of abuse/dependence; sudden death, myocardial infarction, stroke in those with cardiac structural abnormalities
    • Psychiatric: Psychosis, mania, aggression, suicidal ideation
    • Cardiovascular: Cardiomyopathy, Raynaud's phenomenon
    • Growth suppression in children; priapism; serotonin syndrome (with serotonergics); hypersensitivity reactions

Monitoring / Labs

  • Baseline and periodic: Heart rate, blood pressure, weight, height (pediatrics)
  • Psychiatric: Screen for bipolar, psychosis risk; monitor mood/behavior
  • Cardiac: ECG if history of heart disease; assess for misuse/diversion
  • Growth: Plot height/weight percentiles; consider drug holiday if suppression
  • No routine labs required; assess renal/hepatic function if impaired

Education

  • When to Call the Doctor:

    • Severe mood changes, aggression, or suicidal thoughts.
    • Chest pain, shortness of breath, or palpitations (cardiovascular concerns).
    • Uncontrolled movements, tics, or worsening anxiety.
    • Signs of circulatory issues (e.g., numbness, coldness, or color changes in fingers/toes).
    • Unexplained weight loss or growth suppression in pediatric patients.
  • Safety Tips:

    • Monitor blood pressure and heart rate regularly, especially in patients with cardiovascular risk.
    • Use caution in patients with history of anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
    • Avoid caffeine and other stimulants, which may increase side effects.
    • Ensure adequate hydration and nutrition, as appetite suppression is common.
    • Do not abruptly discontinue; tapering may be needed in long-term users.
  • Parent Tips for Pediatric Patients:

    • Encourage a high-calorie diet to offset appetite suppression.
    • Monitor school performance and behavioral changes.
    • Administer the first dose before school for optimal effect.
    • Observe for sleep disturbances and adjust dosing schedule if needed.
    • Keep communication open with teachers and caregivers regarding medication effects.

Additional Information

  • Contraindications:

    • Hypersensitivity to amphetamines or any 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).

References

  1. FDA Prescribing Information - Adderall Tablets, 2007, https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf
  2. DailyMed - Mixed Salts of a Single Entity Amphetamine Product, 2023, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=175e125c-8df5-484c-a5c0-4b61e05f75ba
  3. StatPearls - Dextroamphetamine-Amphetamine, 2023, https://www.ncbi.nlm.nih.gov/books/NBK507808/
  4. DrugBank - Amphetamine, 2024, https://go.drugbank.com/drugs/DB00182