HYOSCINE BUTYLBROMIDE INJECTION 10MG/1ML

Indicatios:

Hyoscine butylbromide is indicated in acute spasm, as in renal or biliary colic, in radiology for differential diagnosis of obstruction and to reduce spasm and pain in pyelography, and in other diagnostic procedures where spasm may be a problem (e.g. gastroduodenal endoscopy).

Dosage and administration：

Adults

20 mg intravenously or intramuscularly, repeated after half an hour if necessary. Intravenous injection should be performed 'slowly' (in rare cases a marked drop in blood pressure and even shock may be produced by hyoscine injection).

When used in endoscopy this dose may need to be repeated more frequently.

Maximum daily dose is 100 mg.

Special populations

Paediatric population

Not recommended.

Hyoscine butylbromide injection should not be used on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

Method of administration

For intravenous and intramuscular injection.

Hyoscine butylbromide solution for injection may be used diluted with glucose or with sodium chloride 0.9% solution for injection.

Contraindications:

Hyoscine butylbromide is contraindicated in patients with:

- hypersensitivity to the active substance or to any of the excipients

- narrow angle glaucoma

- prostate hypertrophy with urinary retention

- mechanical stenosis in the gastrointestinal tract

- paralytic or obstructive ileus

- megacolon

- tachycardia

- myasthenia gravis

Hyoscine butylbromide should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.

Precautions:

In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in stool, appropriate diagnostic measures are needed to investigate the aetiology of the symptoms.

Hyoscine butylbromide can cause tachycardia, hypotension and anaphylaxis, therefore use with caution in patients with cardiac conditions such as cardiac failure, coronary heart disease, cardiac arrhythmia or hypertension, and in cardiac surgery. Monitoring of these patients is advised. Emergency equipment and personnel trained in its use must be readily available.

Because of the possibility that anticholinergics may reduce sweating, hyoscine butylbromide should be administered with caution to patients with pyrexia.

Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as hyoscine butylbromide in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision after the injection of hyoscine butylbromide.

After parenteral administration of hyoscine butylbromide, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving hyoscine butylbromide should be kept under observation.

Drug interactions:

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics (e.g. phenothiazines,butyrophenones), quinidine, disopyramide, amantadine, and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by hyoscine butylbromide.

The tachycardic effects of beta-adrenergic agents may be enhanced by hyoscine butylbromide.

Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

Storage:

Store at or below 30°C protected from light. For single use only. Once opened, any unused portion should be discarded.