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
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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.
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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.
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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
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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.
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Pregnancy:
- Category C; use only if benefits outweigh risks.
- May cause neonatal withdrawal symptoms or low birth weight.
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Lactation:
- Excreted in breast milk; not recommended due to potential infant exposure.
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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).