MAXOLON HIGH DOSE, METOCLOPRAMIDE

Posology All indications (adult population) 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 10 mg, repeated up to three times daily.

5mg/kg body weight. The injectable treatment duration should be as short as possible and transfer to oral treatment should be made as soon as possible. 0μg/ml. The loading dose should be given before starting cytotoxic chemotherapy. Maxolon 'High Dose' (Metoclopramide Infusion) Volume Of Diluent IV Infusion Time Loading dose 2-4 mg/kg body weight 50-100 ml 15-20 minutes Maintenance dose 3-5 mg/kg body weight 500 ml 8-12 hours Total dosage in any 24 hour period should not normally exceed 10 mg/kg body weight.

Where cisplatin is to be used the loading dose of this medicine should be at least 3 mg/kg body weight and the maintenance dose at least 4 mg/kg body weight. Intermittent Infusion (alternative regimen) This medicine can be given by intermittent IV infusion suitably diluted.

The initial dose should be given before starting cytotoxic chemotherapy. Maxolon 'High Dose' (Metoclopramide Infusion) Volume Of Diluent IV Infusion Time Initial dose Up to 2 mg/kg body weight at least 50 ml at least 15 minutes Repeat doses at 2 hourly intervals Up to 2 mg/kg body weight at least 50 ml at least 15 minutes Total dosage in any 24 hour period should not normally exceed 10 mg/kg body weight.

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). 2).

Compatibility with cytotoxic agents:

This medicine is compatible with a number of cytotoxic drugs; however it should not be mixed in solution with therapeutic agents other than those stated. This medicine is compatible with cisplatin, cyclophosphamide and doxorubicin hydrochloride and is stable over the concentration ranges listed below for 24 hours at room temperature when protected from light.

9%. Up to 40 mg doxorubicin hydrochloride (powder) per 100 mg/20 ml of this medicine. Up to 4 g cyclophosphamide (1 g/50 ml) per 100 mg/20 ml of this medicine.

Compatibility with morphine/diamorphine:

This medicine is compatible with morphine hydrochloride and diamorphine hydrochloride and is stable over the concentration ranges listed below for 48 hours at room temperature under normal fluorescent lighting. Up to 100 mg of morphine hydrochloride per 100 mg/20 ml of this medicine.

Up to 50 mg of diamorphine hydrochloride per 100 mg/20 ml of this medicine. 9%.

Stability in intravenous fluids:

Ideally intravenous solutions should be prepared at the time of infusion. g. ViaflexR Travenol). P. P. P. P. (Ringer-lactate solution; Hartmann’s solution) Note: preparation must be under appropriate aseptic conditions if the above extended storage periods are required.

The high dose ampoule presentation is not suitable for multidose use. 15 mg/kg body weight, repeated up to three times daily by intravenous route. 5 mg/kg body weight. 5 mg Up to 3 times daily 9-15 years 30-60 kg 5 mg Up to 3 times daily 15-18 years Over 60kg 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). For the treatment of postoperative nausea and vomiting, metoclopramide should be administered after the termination of the surgical procedure.

15 mg/kg body weight given as a slow injection (at least 3 minutes). 4). Metoclopramide should not be used in children younger than 1 year as there are insufficient data regarding efficacy and safety of the product in this patient population see section

Adverse reactions listed by System Organ Class.

Frequencies are defined using the following convention:

Very common (≥1/10), Common (≥1/100to <1/10), Uncommon (≥1/1,000to <1/100), Rare (≥1/10,000to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data). 4). 3), Transient increase in blood pressure Gastrointestinal disorders Common Diarrhoea General disorders and administration site conditions Common Asthenia * 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).

Since extrapyramidal symptoms may occur with both metoclopramide and neuroleptics such as the phenothiazines, particular care should be exercised in the event of these drugs being prescribed concurrently. 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. Methaemoglobinemia Methemoglobinemia 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). Risk-benefit should be carefully considered in patients with significant hepatic or renal impairment (loss of conjugation and increased risk of extrapyramidal effects) or with Parkinson’s disease (symptoms may be exacerbated).

g. cerebral irritation. Care should be exercised in patients being treated with other centrally acting drugs. This medicine should be used with care in combination with other serotonergic drugs including SSRIs. Patients receiving this drug for the disorders associated with delayed gastric emptying should be reviewed at an early stage for response to treatment.

Metoclopramide may cause elevation of serum prolactin levels. Care should be exercised when using this medicine in patients with a history of atopy (including asthma) or porphyria. e. essentially ‘sodium- free’.

3. Method of administration This medicine is administered by IV infusion, suitably diluted. The recommended method of administration is by continuous infusion which allows steady serum levels of metoclopramide to be maintained. 1. 5)  Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.

4)