Metoclopramide

Adult dose, §4.2 verbatim: 'The recommended single dose is 10 mg, repeated up to three times daily. The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight.' DURATION, §4.2: 'The maximum recommended treatment duration is 5 days.' Note an internal inconsistency in this SPC: §4.4 separately states 'Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed 3 months because of the risk of tardive dyskinesia.' Both are quoted as they appear; the §4.2 5-day limit is the shorter and operative one. ELDERLY, §4.2: 'In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.' PARENTERAL ADMINISTRATION — the SPC gives NO intravenous or intramuscular dose, only §4.4: 'Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia)', and warns of 'serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following administration of metoclopramide by injection, particularly via the intravenous route'. NEUROLOGICAL, §4.4: 'Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms' and 'Treatment must be discontinued if clinical signs of tardive dyskinesia appear.' CROSS-CHECK ONLY — the US label (metoclopramide oral solution, American Health Packaging) gives different, indication-specific oral figures that are NOT UK posology and are NOT published here: symptomatic gastro-oesophageal reflux '10 mg to 15 mg metoclopramide orally up to 4 times daily 30 minutes before each meal and at bedtime', 'single doses up to 20 mg prior to the provoking situation', '5 mg per dose' for patients more sensitive to the drug such as the elderly, and diabetic gastroparesis '10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks'; that label also caps therapy at 12 weeks rather than 5 days. Neither the UK §4.1 (therapeutic indications) nor an injection SPC was fetched in this bundle, so this draft does not assert which indications the SPC dose covers.

§4.2, verbatim: 'Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3). The recommended single dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily. The maximum dose in 24 hours is 0.5 mg/kg body weight.' The per-kilogram figure entered here is 0.1 — the LOWER bound of the SPC's 0.1 to 0.15 mg/kg PER-DOSE range; always check the calculated result against the SPC's own age/weight banded table, verbatim: 1-3 years, 10-14 kg, 1 mg; 3-5 years, 15-19 kg, 2 mg; 5-9 years, 20-29 kg, 2.5 mg; 9-18 years, 30-60 kg, 5 mg; 15-18 years, over 60 kg, 10 mg — all 'up to 3 times daily'. CONCENTRATION: 1 mg/mL is the strength of the product this SPC covers (Metoclopramide 5 mg/5 ml Oral Solution = 1 mg per mL). It does NOT apply to metoclopramide injection or to any other oral strength — check the label of the product in hand before calculating a volume. A minimum 6-hour interval between administrations must be respected even in case of vomiting or rejection of the dose, and the maximum recommended treatment duration is 5 days (§4.2). §4.4: 'Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions occur usually at the beginning of the treatment and can occur after a single administration. Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms.' The US label is NOT a paediatric source here — it states 'Safety and effectiveness in pediatric patients have not been established' and warns that 'Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric population than in adults.' Verify all paediatric dosing against a children's formulary.