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

Logo Q-MED HYOSCINE 20 mg/mL Injection

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

Q-MED HYOSCINE 20 mg/mL Injection

COMPOSITION:
Each 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 gastrointestinal spasm.

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

DOSAGE AND DIRECTIONS FOR USE:
The usual dose is 20 mg intramuscular or intravenous, repeated after 30 minutes, if necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
It should be used with caution in children and in geriatric patients, who may be more susceptible to its adverse effects.
Dryness of the mouth, with difficulty in swallowing, thirst, dilatation 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. Retrosternal pain may occur due to increased gastric reflux.
Patients who experience drowsiness should not drive or operate machinery. Alcohol should be avoided. It has been stated that in elderly patients and in patients with impaired metabolic, liver or kidney function, adverse central nervous system effects such as disorientation, delirium or somnolence have been more likely to occur. It should be used with caution in conditions characterised by tachycardia such as 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 infarction as ischaemia and infarction 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 concomitantly, as central nervous system depression may be enhanced.
The effects of antimuscarinic agents may be enhanced by drugs with antimuscarinic properties, such as amantadine, some antihistamines, butyrophenones and phenothiazines, and tricyclic antidepressants.

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 anticholinergic 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 be given as required.

IDENTIFICATION:
Clear, colourless solution in amber ampoules.

PRESENTATION:
Amber ampoules containing 20 mg/1 mL.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
29/11.2/0560

NAME AND BUSINESS ADDRESS OF APPLICANT:
Quatromed Limited
10 Lindley Street
BETHLEHEM
9700

DATE OF PUBLICATION:
August 1994                PHY0101/12-96

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