METOCLOPRAMIDE

The solution can be administered intravenously or intramuscularly. Intravenous doses should be administered as a slow bolus (at least over 3 minutes). 15 mg/kg body weight, repeated up to three times daily by intravenous route. 5 mg/kg body weight.

4). 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). All indications (adult patients) For prevention of PONV a single dose of 10mg is recommended. 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.

The maximum recommended treatment duration is 5 days. 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 ≤ 15 ml/min), the daily dose should be reduced by 75%.

2). 3)

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), 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 Skin disorder Not known Skin reactions such as rash, pruritus, angioedema and urticaria *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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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). Metoclopramide should be used with caution in patients with hypertension, since there is limited evidence that the drug may increase circulating catecholamines in such patients. Because metoclopramide can stimulate gastro-intestinal mobility, the drug theoretically could produce increased pressure on the suture lines following gastro- intestinal anastomosis or closure.

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). 8)). g. hypotension, akathisia). 2). Metoclopramide may cause elevation of serum prolactin levels. Care should be exercised when using Metoclopramide 5 mg/ml Injection in patients with a history of atopy (including asthma) or porphyria.

5) • Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency. 4) • Metoclopramide 5 mg/ml Injection 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).