METOCLOPRAMIDE

Posology: 10mg/2ml and 100mg/20ml Injection All indications (adult patients) For prevention of PONV a single dose of 10mg is recommended. For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10mg, repeated up to three times daily.

5mg/kg body weight. The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible. 15mg/kg body weight, repeated up to three times daily by intravenous route.

5mg/kg body weight. 5 mg Up to 3 times daily 9 – 18 years 30 – 60 kg 5 mg Up to 3 times daily 15 – 18 years Over 60 kg 10 mg Up to 3 times daily The maximum treatment duration is 48 hours for treatment of established post operative nausea and vomiting (PONV).

The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV). 100mg/20ml INJECTION Metoclopramide Injection 100mg/20ml may be given in doses of up to 2mg/kg body weight by IV infusion, suitably diluted.

The initial dose should be given prior to commencement of cytotoxic chemotherapy. Dosage may be repeated 2 hourly up to a maximum of 10mg/kg body weight in any 24 hour period. It is recommended that each dose be added to at least 50ml of an appropriate diluent (see below) and infused over at least 15 minutes.

The cytotoxic agent should be administered as a separate infusion. Note: the high dose ampoule presentation is not suitable for multidose use.

Stability in intravenous fluids:

Intravenous solutions should be prepared as near as possible to the time of infusion. However Metoclopramide Injection has been shown to be stable in the solutions listed below for at least 24 hours at room temperature. 9%w/v). 3%). Special population Elderly In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment:

In patients with end stage renal disease (Creatinine clearance ≤ 15ml/min), the daily dose should be reduced by 75%. 2). 2). 3).

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

4) Psychiatric disorders Common Depression Uncommon Hallucination Rare Confusional state Vascular disorder Common Hypotension, particularly with intravenous formulation Not known Shock, syncope after injectable use. 3), transient increase in blood pressure *Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).

4). - Drowsiness, decreased level of consciousness, confusion, hallucination. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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g. cerebral irritation. Neurological Disorders 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. These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults).

2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose. Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly.

8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear. 8). Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

3). Symptoms of Parkinson's disease may also be exacerbated by metoclopramide. Methaemoglobinaemia Methaemoglobinaemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).

8). Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

g. hypotension, akathisia). 2). Metoclopramide may cause elevation of serum prolactin levels. Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria. Metoclopramide should not be used in the immediate post-operative period (up to 3-4 days) following pyloroplasty or gut anastomosis, as vigorous gastrointestinal contractions may adversely affect healing.

1. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk. Confirmed or suspected phaeochromocytoma, due to the risk of severe hypertensive episodes.

History of neuroleptic or metoclopramide-induced tardive dyskinesia. Epilepsy (increased crises frequency and intensity). Parkinson’s disease. 5). Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.

4). Metoclopramide should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing. 6).