CLOPAMON INJECTION 10 mg/2 mL

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

CLOPAMON INJECTION 10 mg/2 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CLOPAMON INJECTION 10 mg/2 mL

COMPOSITION:
Injection - Containing Metoclopramide (base) 10 mg/2 mL

PHARMACOLOGICAL CLASSIFICATION:
A5.7.2 (Anti-emetics and antivertigo preparations)

PHARMACOLOGICAL ACTION:
Gastro-intestinal action: Clopamon increases the number, mean strength and total activity of gastric antral contractions and also produces a significant increase in the strength of duodenal contractions. These changes would all tend to increase the speed of gastric emptying, which has been observed radiologically and by other methods. Clopamon has no effect on gastric secretion or on the cardiovascular system.
Clopamon has an effect on the gastro-oesophageal junction of the stomach, producing an increase in cardiac sphincter pressure. The increase in pressure seen after Clopamon administration is directly proportional to the initial resting pressure and minimal or absent in those with very low resting pressures.
The action of Clopamon on the gastro-intestinal tract is antagonised by atropine and other anticholinergic drugs if they are administered in the previous 3 hours.
Anti-emetic action: Clopamon acts on the chemo-emetic trigger zone to produce a central anti-emetic effect. The anti-emetic action of Clopamon is not affected by atropine and other anticholinergic drugs.
Other action: Clopamon stimulates prolactin secretion.

INDICATIONS:
Digestive Disorders: Clopamon is of value in any condition associated with gastric status or hypomotility. It is, therefore, useful in the management of post-vagotomy syndrome.
Nausea and Vomiting: Clopamon is an effective anti-emetic agent in the control of nausea and vomiting associated with the following conditions : drug-induced nausea and vomiting, uraemic conditions, malignant disease, gastro-intestinal disorders and postanaesthetic vomiting.
Diagnostic Radiology: Clopamon speeds gastric emptying and dilates the duodenal bulb. It is, therefore particularly useful in the following situations:

(a)	where barium meal studies are delayed by spasm of the duodenal cap making examination for the presence of an ulcer difficult.
(b)	to facilitate examination of the hypotonic stomach with delayed emptying (gastric stasis and pyloric canal syndrome).
(c)	to control or prevent nausea and vomiting of barium which occurs in a small minority of patients undergoing barium meal examination.

Duodenal Intubation: The action of Clopamon in promoting stomach emptying, combined with its anti-emetic effect, has proved a very useful aid to gastro-intestinal intubation procedures.

CONTRA-INDICATIONS:
Clopamon should not be given to patients being treated with phenothiazines. Two cases of hypertensive crisis have reportedly been associated with metoclopramide after administration to patients with phaeochromocytoma. Until further evaluation, Clopamon should not be given to patients with suspected or confirmed phaeochromocytoma.

WARNINGS:
The use of Clopamon during pregnancy is not advised.

DOSAGE AND DIRECTIONS FOR USE:

Parenteral:	Adults and children over 14 years: 10 mg (1 ampoule) 1 to 3 times daily, I.V. or I.M. depending on the severity of the condition.
	Children 5 - 14 years: 2,5 mg (0,5 mL of 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.
	Children 3 - 5 years: 1 mg (0,2 mL of 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.
	Children 1 - 3 years: 0,5 mg (0,1 mL of 10 mg/2 mL ampoule) I.V. or I.M. in a tuberculin syringe twice daily.

Dosage for Diagnostic Radiology:

Intravenous:	10 to 20 mg (1 - 2 ampoules) 5 - 15 minutes before the barium meal
Intramuscular:	10 to 20 mg (1 - 2 ampoules) 10 - 15 minutes before the barium meal.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Subjective feelings of restlessness have been reported. These may be associated with overdosage. Extra-pyramidal dystonic-like reactions may occur; the findings include spasm of facial and/or extraocular muscles, trismus, a bulbar type of speech and unnatural positioning of the head and shoulders. There may be a general increase in muscle tone.
The majority of these reactions occur within 36 hours of starting treatment and disappear within 24 hours of withdrawal of the drug.
Should active therapy be required, an antimuscarinic anti-Parkinson drug may be used. The hyperprolactinaemia which Clopamon produces may result in breast engorgement and lactorrhoea. The condition returns to normal after withdrawal of the drug.
As both Clopamon and the phenothiazines may cause transient dystonia, care should be exercised in the event of both drugs being prescribed concurrently.
On no account should Clopamon ampoules be diluted for injection since this will upset the isotonicity and stability of the drug.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of Clopamon could give rise to dyskinetic reactions manifested as motor restlessness, agitation, irritability, spasm of facial and neck muscles and the muscles of the tongue. In severe cases opisthotonus can result. Anti-Parkinson medications, e.g. procyclidine, will usually control these reactions.

IDENTIFICATION:
Injection: Clear, colourless liquid in ampoules.

PRESENTATION:
Injectable: packs of 10 glass ampoules each containing 10 mg/2 mL

STORAGE INSTRUCTIONS:
Ampoules: store below 25°C; protect from light. Should inadvertent exposure occur, reject ampoules showing a yellow discolouration.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
P/5.7.2/53

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (Pty) Ltd
6 Gibaud Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1981

12-095/3-93