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).