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Adderall XR

(amphetamine/dextroamphetamine extended-release)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg

Dosing

  • Age: Pediatric patients ≥6 years and adults
  • Onset: Approximately 30–60 minutes
  • Duration: 10–12 hours
  • Release Profile: Biphasic – an immediate-release portion followed by a delayed-release phase via beaded capsule technology
  • Considerations: May be taken with or without food; avoid concomitant use with acidifying agents which may affect absorption
  • Initial Dose (Pediatric):
    • Typically 10 mg once daily in the morning
  • Titration (Pediatric):
    • Increase by 5–10 mg increments at weekly intervals based on clinical response and tolerability
  • Max Dose (Pediatric):
    • Generally should not exceed 30 mg per day

Quick Facts

  • Mechanism: Increases the synaptic levels of norepinephrine and dopamine
  • Main Benefits: Improves attention, reduces hyperactivity and impulsivity
  • Side Effects: Decreased appetite, insomnia, headache, stomach upset
  • Formulation Technology: Advanced beaded capsule system providing dual-phase drug release
  • Special Notes: High potential for abuse; use with caution in patients with pre-existing cardiovascular conditions

Mechanism of Action

  • Adderall XR contains mixed amphetamine salts that work by enhancing the release of norepinephrine and dopamine, thereby improving neurotransmission which aids in reducing ADHD symptoms.

Indications

  • Attention-Deficit/Hyperactivity Disorder (ADHD) (ICD-10: F90.0)

Off-Label Uses

  • Narcolepsy (ICD-10: G47.4) – Although primarily indicated for ADHD, Adderall XR may be used off-label in adults for the treatment of narcolepsy.

How to Take

  • Take once daily in the morning to avoid insomnia
  • May be taken with or without food; note that high-fat meals can delay absorption
  • Swallow the capsule whole; do not crush or chew
  • General missed-dose advice: Take as soon as remembered unless it is close to the next scheduled dose

Side Effects

  • Common:
    • Central Nervous System: Insomnia, headache, irritability
    • Gastrointestinal: Decreased appetite, stomach upset, dry mouth
  • Serious:
    • Cardiovascular: Increased blood pressure, tachycardia, potential for arrhythmias

Monitoring/Labs

  • Vital Signs: Monitor blood pressure and heart rate periodically
  • Growth Parameters: In pediatric patients, monitor height and weight at regular intervals
  • Mental Health: Monitor for new or worsening psychiatric symptoms, including mood changes and anxiety
  • Abuse Potential: Monitor for signs of misuse or diversion

Education

  • When to Call the Doctor:
    • Experiencing chest pain, shortness of breath, or significant changes in mood or behavior
  • Safety Tips:
    • Take medication strictly as prescribed
    • Do not share medication with others
    • Keep the medication in a secure place out of reach of children
    • Avoid alcohol and other CNS stimulants
    • Report any concerning side effects promptly to your healthcare provider
  • Tips for Pediatric Patients:
    • Ensure dosing is appropriate for your child's weight and age
    • Monitor changes in appetite and growth
    • Maintain regular follow-up visits with the healthcare provider
    • Inform school personnel and caregivers about the medication schedule

Long-Term Use Considerations

  • Periodic evaluation of cardiovascular status, especially in patients with underlying conditions
  • Regular monitoring of growth and development in pediatric patients
  • Assess for potential abuse or dependency over extended periods of use

Tapering Guidance

  • Clinical Guidelines: Gradual dose reduction is recommended to mitigate withdrawal symptoms
  • Caregiver Considerations: Work closely with your healthcare provider to design an individualized tapering schedule

Additional Information

  • Contraindications:
    • History of cardiovascular disease, hyperthyroidism, or glaucoma
  • Pregnancy:
    • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus (Category C)
  • Lactation:
    • May be excreted in breast milk; consult with your healthcare provider before use
  • Drug Interactions:
    • Potential interactions with monoamine oxidase inhibitors (MAOIs), antacids, and other stimulants

References

  • U.S. Food and Drug Administration. (2012). Adderall XR Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s062lbl.pdf
  • DailyMed. (2021). Adderall XR Drug Information. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bd6a68a-35a8-41ad-8b8e-d1e4a7b2123f
  • Faraone, S. V., Biederman, J., & Mick, E. (2020). Pharmacotherapy of attention-deficit/hyperactivity disorder: Current trends. Current Opinion in Psychiatry, 33(4), 321–326.