Methylphenidate hydrochloride

IMPORTANT — FORMULATION SCOPE: the only SPC fetched is Affenid XL 18 mg PROLONGED-RELEASE tablets, so every figure here is the once-daily modified-release regimen. This source contains NO immediate-release regimen; the IR schedule shown on the page (5 mg BD–TDS titrated weekly) is not covered by this source and must be sourced separately. §4.2 also warns that 'Lower doses of short-acting methylphenidate formulations may be considered sufficient' for both adults and children new to methylphenidate. Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD (expert paediatrician, child and adolescent psychiatrist, or adult psychiatrist). PRE-TREATMENT: in adults new to methylphenidate, and if required by national practice, cardiologist advice is needed before initiation to check absence of cardiovascular contraindications; baseline cardiovascular evaluation (blood pressure and heart rate), comprehensive history and pre-treatment height/weight are required. TITRATION: start at the lowest possible dose; dosage adjustment may generally proceed at approximately weekly intervals; a 27 mg strength is available for prescribing between 18 mg and 36 mg. CONVERSION from methylphenidate three times daily (§4.2 Table 1): 5 mg TDS → 18 mg once daily; 10 mg TDS → 36 mg once daily; 15 mg TDS → 54 mg once daily; 20 mg TDS → 72 mg once daily. Discontinue if improvement is not observed after appropriate dosage adjustment over a one-month period; reduce or discontinue if paradoxical aggravation of symptoms or other serious adverse events occur. MONITORING: blood pressure and pulse at each dose adjustment then at least 6-monthly; weight recorded regularly in adults; height, weight and appetite at least 6-monthly in children; psychiatric status at each dose adjustment then at least 6-monthly. Monitor for diversion, misuse and abuse. LONG-TERM: safety and efficacy of use beyond 12 months not systematically evaluated; de-challenge at least once yearly. ELDERLY: 'Methylphenidate should not be used in the elderly' — safety and efficacy not established; not studied over 65 years. HEPATIC IMPAIRMENT: not studied. PAEDIATRIC (§4.2, not a per-kg dose): children new to methylphenidate — recommended starting dose 18 mg once daily; maximum daily dosage 54 mg in children. Must not be used in children under 6 years of age (safety and efficacy not established). May be taken with or without food.