Amdipharm Limited

Maxolon 5 mg/ml Solution for Injection

Each 2ml ampoule contains metoclopramide hydrochloride equivalent to 10mg of the anhydrous substance.

For excipients, see section 6.1.

Solution for Injection.

Clear colourless solution.

Adults 20 years and over:

1) Disorders of the gastrointestinal tract associated with delayed gastric emptying e.g. reflux oesophagitis, hiatus hernia, post-vagotomy syndrome.

2) Nausea and vomiting associated with administration of some cytotoxic drugs and radiotherapy.

3) Diagnostic procedures e.g. barium studies and duodenal intubations.

4) To counteract gastric stasis associated with attacks of migraine and assist absorption of orally administered analgesics for that condition.

Young adults and Children:

The use of Maxolon in patients under 20 years should be restricted to the following: vomiting associated with radiotherapy and intolerance to cytotoxic drugs, as an aid to gastro-intestinal intubation.

Route of administration:

IM or IV: Maxolon may be administered at the dosages stated below, either intramuscularly or by slow intravenous injection (1-2 minutes).

Dosage and Administration:

The dosage recommendations given below should be strictly adhered to if side-effects of the dystonic type are to be avoided. It should be noted that total daily dosage of Maxolon, especially for children and young adults, should not normally exceed 0.5mg/kg body weight.

In patients with clinically significant degrees of renal or hepatic impairment, therapy should be at reduced dosage.

Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.

Medical indications:

Adults 20 years and over: 10mg three times daily. For patients of less than 60kg see below.

Elderly patients: As for adults. To avoid adverse reactions adhere strictly to dosage recommendations and where prolonged therapy is considered necessary, patients should be regularly reviewed.

Young adults and children: Maxolon should only be used after careful examination to avoid masking an underlying disorder, e.g. cerebral irritation. In the treatment of this group attention should be given primarily to body weight and treatment should commence at the lower dosage where stated.

Young adults:

Children:

Diagnostic indications: A single dose of Maxolon may be given 5-10 minutes before the examination. Subject to body weight consideration, (see above), the following dosages are recommended.

Use in patients with phaeochromocytoma, as an acute hypertensive response may be induced.

Use in patients suffering from epilepsy, since the frequency and severity of seizures may be increased.

Use in presence of gastrointestinal haemorrhage, mechanical obstruction or perforation.

Use in patients with a previously history of hypersensitivity to metoclopramide or excipients.

If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder e.g. cerebral irritation.

Care should be exercised in patients being treated with other centrally acting drugs.

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).

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 effect healing.

The neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section adverse reactions).

Maxolon should be used with care in combination with other serotonergic drugs including SSRIs.

Various extrapyramidal reactions to metoclopramide, usually of the dystonic type, can occur. The incidence of these reactions in children and young adults may increase if a daily dosage higher than 0.5 mg/kg is administered.

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 Maxolon in patients with a history of atopy (including asthma) or porphyria.

Concomitant use of anticholinergic drugs may inhibit the favourable effects on gastrointestinal motility.

Since metoclopramide influences gastrointestinal motility and absorption, the dosage of other drugs used concomitantly may possibly need adjustment.

This product may potentiate the effects of alcohol.

Since extrapyramidal reactions may occur with metoclopramide and phenothiazines, care should be exercised when both are used concurrently.

The effects of certain other drugs with potential central stimulant effects, e.g. monoamine oxidase inhibitors and sympathomimetics, may be modified when prescribed with metoclopramide and their dosage may need to be adjusted accordingly.

The use of Maxolon with serotonergic drugs may increase the risk of serotonin syndrome.

This product should not be used in pregnancy and lactation unless considered absolutely essential by the physician.

Metoclopramide is excreted in breast milk and should not be given to nursing mothers.

.

None, but see 4.8.

Use of this drug may increase extrapyramidal side effects, including facial spasm, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of extra ocular muscles including oculogyric crises, unnatural positioning of head and shoulders.

Very rarely hypersensitivity, including anaphylaxis, has been reported.

Rarely diarrhoea, drowsiness, restlessness, confusion and anxiety have been reported in patients receiving metoclopramide therapy. Depression has been reported extremely rarely. Very rare occurrences of the neuroleptic malignant syndrome have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of Creatine Phosphokinase (CPK) and must be treated urgently (recognised treatments include dantrolene and bromocriptine). Metoclopramide should be stopped immediately if this syndrome occurs.

Tardive dyskinesia, which may be persistent, has been reported as a side effect in elderly patients undergoing long-term therapy with metoclopramide. Prolonged therapy in such patients should be carefully reviewed. The likelihood of the occurrence of this serious effect is increased when neuroleptic agents are used concurrently.

Extremely rarely cases of red cell disorders such as methaemoglobinaemia and sulphaemoglobinaemia have been reported, particularly at high doses of metoclopramide. If this occurs the drug should be withdrawn. Methaemoglobinaemia may be treated using methylene blue.

There have been very rare reports of abnormalities of cardiac conduction (e.g. bradycardia and heart block) in association with I.V metoclopramide.

Anaphylactic reactions, angioedema, urticaria and rash have been reported very rarely.

Acute hypertension may occur in patients with phaeochromocytoma (see section 4.3 Contraindications).

Overdosage, should be treated by appropriate supportive measures. Should treatment of a dystonic reaction be required, an anticholinergic anti-parkinsonian drug, or a benzodiazepine may be used.

Metoclopramide is a benzamide derivative which acts peripherally to enhance cholinergic action at muscarinic synapses and in the central nervous system to antagonise dopamine.

Absorption from the gut is rapid and the drug undergoes significant first-pass hepatic metabolism. It is excreted in the urine as unchanged drug and metabolites in both free and conjugated form. The drug is also excreted in breast milk.

No additional data available.

Sodium chloride

Sodium metabisulphite (E223)

Water for injection

Maxolon Ampoules should not be mixed with any other drugs in the same injection solution or in the same syringe.

The shelf life expiry date for this product shall not exceed 5 years from the date of its manufacture, when stored protected from light.

Do not store above 25°C. Keep the ampoules in the outer carton.

Packs of 12 clear glass 2ml ampoules.

Discard discoloured solutions.

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

PA

1 April 1994 / 1 April 2004