PARAMAX

paracetamol/metoclopramide hydrochloride

Presentation

Round, biconvex, white tablets, 12.5mm in diameter with "PARAMAX" debossed on one side and breakbar on the other. Each tablet contains 500mg Paracetamol B.P. with Metoclopramide Hydrochloride B.P. equivalent to 5mg metoclopramide.

Clinical Particulars

Therapeutic indications

PARAMAX is indicated for the symptomatic treatment of migraine.

It is also indicated for the treatment of pain accompanied by gastric stasis or nausea and vomiting.

Posology and method of administration

For oral administration only.

PARAMAX should be taken at the first warning of an attack. If symptoms persist, further doses may be taken at 4 hourly intervals. Total dosage in any 24 hour period should not exceed the quantity stated.

Usual recommended dosage

Children

A presentation of PARAMAX suitable for the treatment of children under 12 years of age is not available.

Note: Total daily dosage of metoclopramide should not exceed 0.5mg/kg bodyweight.

Contraindications

There are no absolute contraindications.

Following operations such as pyloroplasty or gut anastomosis therapy should be withheld for three or four days as vigorous muscular contractions may not help healing.

Special warnings and special precautions for use

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 active medicines e.g. in epilepsy. Since extrapyramidal symptoms may occur with both PARAMAX and phenothiazines, care should be exercised in the event of both medicines being prescribed concurrently.

Metoclopramide may induce an acute hypersensitive response in patients with phaeochromocytoma.

Interaction with other medicaments and other forms of interaction

The action of metoclopramide on the gastrointestinal tract is antagonized by anticholinergics.

The absorption of any concurrently administered oral medication may be modified by the effect of PARAMAX on gastric motility.

Pregnancy and lactation

Pregnancy

Adequate human data on use during pregnancy are not available. However, animal studies have not identified any risk to pregnancy or embryo-foetal development.

Lactation

Adequate human data on use during lactation and adequate animal reproduction studies are not available.

Effects on ability to drive and use machines

None known.

Undesirable effects

Various extrapyramidal reactions to metoclopramide, usually of the dystonic type, have been reported. The incidence of these reactions may be increased if the metoclopramide dosage exceeds 0.5 mg/kg body weight per day. Reactions include:

• spasm of the facial muscles
• trismus
• rhythmic protrusion of the tongue
• a bulbar type of speech spasm of extraocular muscles
• including oculogyric crises
• unnatural positioning of the head and shoulders
• opisthotonos

There may be a generalized 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 medicine. Should treatment of a reaction be required, a benzodiazepine, and anticholinergic or and antiparkinson agent may be used.

Rarely, drowsiness, restlessness, acute depression and diarrhea have been reported in patients receiving metoclopramide therapy. Anxiety or agitation may occur, especially after rapid injection.

Elevated serum prolactin levels and galactorrhoea may occur during metoclopramide therapy.

Overdose

See Undesirable effects for treatment of extrapyramidal reactions.

As with other paracetamol-containing products, an overdose of can be toxic to the liver. Overdosage should be treated by gastric lavage with appropriate supportive measures. Intravenous N-acetylcysteine or oral methionine if administered within 10 hours of paracetamol overdosage appears to exert a protective effect on the liver.

Pharmacological Properties

Paracetamol relieves pain. More rapid absorption is promoted by the action of metoclopramide which also relieves gastric stasis and overcomes nausea and vomiting.

An acute attack of migraine is frequently characterised by impaired absorption of analgesics even when abdominal symptoms are absent. The beneficial effect of delayed gastric emptying, nausea and vomiting contrasts with the gastric stasis which may occur following administration of phenothiazine or antihistamine antiemetics.

Pharmaceutical Particulars

Special precautions for storage

Protect tablets from light.

Shelf life

36 months when stored below 25°C (77°F).

   Inhouse Pharmacy Europe