MEDICYCLOMINE SYRUP
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
MEDICYCLOMINE SYRUP
COMPOSITION:
Each 5mL of flavoured syrup contains 10mg dicyclomine hydrochloride.
PRESERVATIVES:
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Methyl hydroxybenzoate |
0.1% m/v |
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Propyl hydroxybenzoate |
0.02% m/v |
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Contains 14.26% v/v alcohol |
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PHARMACOLOGICAL CLASSIFICATION:
A/11.2/Gastro-intestinal antispasmodics and choliolytics (anti-cholinergics)
PHARMACOLOGICAL ACTION:
Dicyclomine decreases spasm of the gastro-intestinal tract, bilary tract, ureter and uterus without producing characteristic atropine-like effects on the salivary, sweat and gastro-intestinal glands, the eye or the cardiovascular system when given in therapeutic doses. The major action is a non-specific relaxant action on smooth muscle of the gastro-intestinal tract.
INDICATIONS:
Medicyclomine is indicated in conditions associated with spasms of the gastro-intestinal and urinary tracts.
CONTRA-INDICATIONS:
Children less than 12 months of age.
Dicyclomine HC1 should not be given to patients with glaucoma or to patients with a narrow angle between the iris and cornea, since its use may increase the intra-ocular pressure. It is contra-indicated in patients suffering from paralytic ileus, pyloric stenosis, intestinal atony, ulcerative colitis, myathenia gravis or prostatic enlargement.
The established medical principle of exercising extreme caution when administering medicines to pregnant women should be kept in mind. Due to the risk of hyperpyrexia it should not be given to patients where the ambient temperature is high.
DOSAGE AND DIRECTIONS FOR USE:
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Adults: |
10mL three times a day or after meals. |
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Children: |
2 to 12 years 5mL to 10mL three times a day before or after meals.
1 to 2 years 5mL three times a day before or after meals. |
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Atropine-like side-effects may occur, as for instance:
Dryness of the mouth, drowsiness, thirst, dilatation of the pupils with loss of accomodation and photophobia, constipation, urinary urgency, occasional nausea, flushing of the skin and tachycardia. Care should be taken when medicines of this group are administered to patients with prostatic enlargement, coronary insufficiency or cardiac failure. The effects of dicyclomine may, be enhanced by the concomitant administration of other medicines with parasympatholytic properties such as antihistamines, phenothiaszines and tricyclic antidepressants.
Use in pregnancy and during lactation:
Safety in pregnancy has not been established and it is not known whether dicyclomine is excreted in human milk. Caution should be exercised when dicyclomine is administered to a nursing woman.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic; doses can cause bradycardia followed by tachycardia, rapid or loud breathing, hyperpyrexia, hypertension may occur, restlessness, confusion, excitement or hallucinations passing into delirium. A rash may appear on the face and upper trunk. In severe intoxication, depression of the central nervous system may occur with circulatory failure and respiratory depression.
Treatment is symptomatic and supportive.
IDENTIFICATION:
A red flavoured syrup.
PRESENTATION:
In bottles of a 100mL.
STORAGE INSTRUCTIONS:
Store below 25°C, out of direct sunlight. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
M/11.2/142
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
BRUNEL LABORATORIES (PTY) LTD
16 van Tonder Street
SUNDERLAND RIDGE
VERWOERDBURG
DATE OF PUBLICATION:
April 1988
Updated on this site: December 1999 |
