Antidopaminergics.

Metoclopramide - gastrointestinal disorders

Maxolon® Tablets 10mg. Each tablet contains Metoclopramide Hydrochloride BP equivalent to 10mg of the anhydrous substance.

White uncoated tablets scored and engraved 'Maxolon'.

Nausea and vomiting: 'Maxolon' is indicated for the treatment of the nausea and vomiting associated with: Gastro-intestinal disorders, Cyclical vomiting, Intolerance to cytotoxic drugs, Congestive heart failure, Deep x-ray or cobalt therapy, Post-anaesthetic vomiting

Migraine: 'Maxolon' relieves symptoms of nausea and vomiting, and overcomes gastric stasis associated with attacks of migraine. This improvement in gastric emptying assists the absorption of concurrently administered oral anti-migraine therapy (e.g. paracetamol) which may otherwise be impaired in such patients. Post-operative conditions: Post-operative gastric hypotonia Post-vagotomy syndrome 'Maxolon' promotes normal gastric emptying and restores motility in vagotomised patients, and where post-operative symptoms suggest gastro-duodenal dysfunction.

Diagnostic procedures: Radiology, Duodenal intubation 'Maxolon' speeds up the passage of a barium meal by decreasing gastric emptying time, co-ordinating peristalsis and dilating the duodenal bulb. 'Maxolon' also facilitates duodenal intubation procedures. Young adults and children The use of 'Maxolon' in patients under 20 years should be restricted to the following: Severe intractable vomiting of known cause, vomiting associated with radiotherapy and intolerance to cytotoxic drugs, as an aid to gastro-intestinal intubation, and as part of the premedication before surgical procedures

Route of administration:

Oral

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.

Tablets should not be used in children under the age of 15. A liquid presentation should be used in the younger age groups; more accurate dosage is facilitated by the use of the Paediatric Liquid.

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.

A liquid presentation should be used in the younger age groups; more accurate dosage is facilitated by the use of the Paediatric liquid.

Children and Young Adults : Not applicable.

'Maxolon' should not be used in patients with phaeochromocytoma as it may induce an acute hypertensive response.

'Maxolon' 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.

'Maxolon' should not be administered to patients with gastrointestinal obstruction, perforation or haemorrhage.

'Maxolon' is contra-indicated in patients who have previously shown hypersensitivity to metoclopramide or any of its components.

Precautions:

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 epileptic patients and patients being treated with other centrally acting drugs.

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.

The neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy.

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

Special care should be taken in cases of severe renal and hepatic insufficiency.

Care should be exercised when using Maxolon in patients with a history of atopy (including asthma) or porphyria.

The action of 'Maxolon' on the gastro-intestinal tract is antagonised by anticholinergics and opioid analgesics. The absorption of any concurrently administered oral medication may be modified by the effect of 'Maxolon' on gastric motility. Drugs known to be affected in this way include aspirin and paracetamol.

Since extrapyramidal reactions may occur with 'Maxolon', Phenothiazines and Tetrabenazine, care should be exercised in the event of co-administration of these drugs.

'Maxolon' should be used with care in association with other drugs acting at central dopamine receptors, such as levodopa, bromocriptine and pergolide.

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

'Maxolon' may reduce plasma concentrations of atovaquone

Various extrapyramidal reactions to 'Maxolon', usually of the dystonic type, have been reported. The incidence of dystonic reactions, particularly in children and young adults, is increased if daily dosages higher than 0.5mg per kg body weight are administered. Dystonic reactions include: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of extra-ocular muscles including oculogyric crises, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of the drug. Should treatment of a dystonic reaction be required an anticholinergic anti-Parkinsonian drug, or a benzodiazepine may be used.

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 has been reported during prolonged treatment in a small number of mainly elderly patients. Patients on prolonged treatment should be regularly reviewed.

Very rarely hypersensitivity, including anaphylaxis, has been reported.

Rarely, drowsiness, restlessness, confusion, anxiety and diarrhoea have been reported in patients receiving metoclopramide therapy. Depression has been reported extremely rarely.

Raised serum prolactin levels have been observed during metoclopramide therapy: this may result in galactorrhoea, irregular periods and gynaecomastia.

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.

A small number of skin reactions such as rashes, urticaria, pruritus and oedema have also been reported.

Amdipharm

(POM)

24 June 2009