SW Metoclopramide Special Precautions

Neurological disorders: Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions generally occur at the beginning of treatment, and can occur after single dose. If extrapyramidal symptoms occur, metoclopramide should be discontinued immediately. These effects are generally completely reversible after treatment discontinuation; however, symptomatic treatment may be required (benzodiazepines in children, and/or anticholinergic antiparkinsonian medicinal products in adults).
An interval of at least six hours should be respected between each dose, even if vomiting or rejection of the dose occurs, in order to avoid overdose. Long-term treatment with metoclopramide may cause potentially irreversible tardive dyskinesia, particularly in elderly subjects. Treatment should not exceed 3 months because of the risk of tardive dyskinesia. Treatment must be discontinued if clinical signs of tardive dyskinesia occur.
Neuroleptic malignant syndrome has been described with metoclopramide in combination with neuroleptics and with metoclopramide monotherapy. Metoclopramide must be immediately discontinued if symptoms of neuroleptic malignant syndrome develop, and appropriate treatment should be initiated.
Particular caution should be exercised in patients with underlying neurological disorders, and in patients receiving other centrally-acting drugs. Symptoms of Parkinson's disease may also be exacerbated by metoclopramide.
Methemoglobinemia: Methemoglobinemia, which could be related to NADH-cytochrome-b5 reductase deficiency, has been reported. If this occurs, treatment must be immediately and permanently discontinued, and appropriate measures initiated (such as treatment with methylene blue).
Cardiac disorders: Serious cardiovascular undesirable effects, including cases of severe bradycardia, circulatory collapse, cardiac arrest, and QT prolongation, have been reported during administration of metoclopramide by injection, particularly via the intravenous route.
Particular caution should be exercised when administering metoclopramide, particularly via the intravenous route, in elderly subjects, patients with cardiac conduction disorders (including QT prolongation), patients with electrolyte imbalance, bradycardia, and patients taking other drugs known to prolong QT interval. The intravenous injection must be given as slow bolus (of at least 3 minutes duration) in order to reduce the risk of undesirable effects (e.g. hypotension, akathisia).
Kidney or liver failure: In patients with kidney failure or severe liver failure, a dose reduction is recommended.
Avoid doses exceeding 0.5 mg/kg/day.
Extrapyramidal effects, especially dystonic reaction of metoclopramide, are more likely to occur in children shortly after initiation of therapy, and usually with doses higher than 0.5 mg per kg of body weight per day.
Effects on ability to drive and use machines: Not known.