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Concerta

(methylphenidate ER [OROS])

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  •  Tablets: 18 mg, 27 mg, 36 mg, 54 mg

Dosing

  • Age: ≥ 6 y/o
  • Onset: ~ 30-60 min
  • Duration: Up to 12 hours
  • Release Profile: 22% IR, 78% CR via osmotic delivery
  • Considerations: Must be swallowed whole; the non-absorbable shell may pass in stool. Administer once daily in the morning, with or without food. Do not chew or crush the tablet.
  • Initial Dose:
    • 6-12 y/o: 18 mg daily
    • 13+ y/o: 18 mg - 36 mg daily
  • Titration: 18 mg/day at weekly intervals
  • Max Dose:
    • 6-12 y/o: 54 mg/day
    • 13+ y/o: 72 mg/day

Quick Facts

  • Blocks dopamine and norepinephrine reuptake; central nervous system stimulant
  • Uses OROS technology for immediate release followed by slow, consistent release; minimizes plasma fluctuations
  • Can cause psychiatric adverse events; assess for bipolar disorder before starting
  • Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

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; high-fat meals may delay absorption.
  • Swallow the tablet whole with water; do not crush, chew, or split.
  • The osmotic-controlled release system (OROS) shell may appear in the stool; this is normal.

Side Effects

  •  Common: Decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, hyperhidrosis
  • Serious: Cardiovascular events, psychiatric adverse events, seizures, visual disturbances, growth suppression in children

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 methylphenidate 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 methylphenidate levels.
    • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).