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

Logo MICRO HYOSCINE BUTYLBROMIDE INJECTION 20 mg/1 mL

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MICRO HYOSCINE BUTYLBROMIDE INJECTION 20 mg/1 mL

COMPOSITION:
Each 1 mL of injection contains 20 mg
Hyoscine butylbromide.

PHARMACOLOGICAL CLASSIFICATION:
A 11.2 (Gastro-intestinal antispasmodic).

PHARMACOLOGICAL ACTION:
Hyoscine Butylbromide is a quaternary ammonium antimuscarinic agent. Hyoscine butylbromide does not readily pass the blood-brain barrier. It’s a competitive antagonist of the actions of acetylcholine and other muscarinic agonists. The receptors affected are those of peripheral structures that are either stimulated or inhibited by muscarine, ie. exocrine glands, smooth and cardiac muscle.

INDICATIONS:
Hyoscine Butylbromide is used in the treatment of conditions associated with gastro-intestinal spasm.

CONTRA-INDICATIONS:
Hypersensitivity to hyoscine butylbromide. Porphyria. Myasthenia gravis.
Patients with prostatic enlargement, paralytic ileus or pyloric stenosis and fever. In those with ulcerative colitis its use may lead to ileus or megacolon, and its effects on the lower oesophageal sphincter may exacerbate reflux. Closed angle glaucoma, or narrow angle between the iris and cornea, as hyoscine increases intra-ocular pressure. It should not given to patients with myasthenia gravis, unless it is to reduce the adverse muscarinic effects of an anti-cholinesterase agents.
It should not be given to pregnant and lactating mothers as safety has not been established. It has been stated to cross the placenta.

WARNINGS:
Patients who experience drowsiness should not drive or operate machinery. Alcohol should be avoided.

DOSAGE AND DIRECTIONS FOR USE:
The usual dose for adults and children over 12 years of age is 20 mg intramuscular or intravenous, repeated after 30 minutes, if necessary.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Dryness of the mouth, with difficulty in swallowing, thirst, dilation of the pupils with loss of accommodation and photophobia, increased intra-ocular pressure, flushing and dryness of the skin, bradycardia followed by tachycardia, with palpitations and arrhythmias, urinary urgency with the inability to do so, as well as reduction in the tone and motility of the gastro-intestinal tract, leading to constipation. Occasionally vomiting, giddiness and staggering may occur. Restrosternal pain may occur due to increased gastric reflux.
It has been stated that in elderly patients and patients with impaired metabolic, liver or kidney function, adverse central nervous system effects such as disorientation, delirium, or somnolence have been likely to occur.
It should be used with caution in conditions characterised by tachycardia such thyrotoxicosis, cardiac insufficiency or failure, and in cardiac surgery, where it may further accelerate the heart-rate. Care is required in patients with acute myocardial infarcation as ischaemia and infarcation may be worsened. It should be given with care to patients with hypertension.
Hyoscine should be used with care in patients receiving other central depressants, as central nervous system depression may be enhanced.
The effects of antimuscarinic agents may be enhanced by medicines with antimuscarinic properties, such as amantadine, some antihistamines, butyrophenones and phenothiazines, and tricyclic antidepressants.
It should be given with caution to patients with diarrhoea.
It should be used with caution in children and in geriatric patients, who may be more susceptible to its adverse effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
Toxic doses cause tachycardia, rapid respiration, hyperpyrexia, restlessness, confusion, excitement, impotence and hallucinations passing into delirium. A rash may appear on face and upper trunk. In severe intoxication, depression of the central nervous system may occur with circulatory failure and respiratory failure. Quaternary ammonium anti-cholinergic agents usually have some ganglion blocking action, so that high doses may cause postural hypertension and impotence in toxic doses, nondepolarising neuromuscular block may be produced.
Supportive and symptomatic therapy should given as required.

IDENTIFICATION:
Clear, colourless solution in amber ampoules.

PRESENTATION:
Amber ampoules containing 20 mg/1 mL in containers of 10 or 100.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
32/11.2/0242

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MICRO HEALTHCARE (Pty) Ltd
10 Lindley Street
BETHLEHEM
9701
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1994

New addition to this site: September 2005
Source: Pharmaceutical Industry Website

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