Finished product reference

Hyoscine-n-butyl Bromide

Suppository · Rectal · 10 mg

List code
653
Pharmacologic class
Antimuscarinic antispasmodic (quaternary ammonium)

What it is and how it works

Hyoscine butylbromide is a quaternary antimuscarinic that blocks muscarinic receptors in smooth muscle of the gastrointestinal, biliary and genitourinary tracts, relieving spasm. As a quaternary compound it is poorly absorbed orally and does not readily cross the blood–brain barrier.

Indications

Gastrointestinal and genitourinary smooth muscle spasm, including abdominal colic, biliary and renal colic and irritable bowel syndrome; as an aid in diagnostic radiology and endoscopy to reduce spasm.

Dosage and administration (summary)

Oral: 10–20 mg up to 4 times daily. Rectal: 10 mg up to 3–4 times daily. Injection: 20 mg by slow intravenous or intramuscular injection, repeated after 30 minutes if needed (maximum 100 mg daily).

Contraindications

Myasthenia gravis, megacolon, mechanical gastrointestinal obstruction or paralytic ileus, untreated angle-closure glaucoma, tachyarrhythmia and urinary retention due to prostatic enlargement.

Warnings and precautions

Injection can cause serious adverse effects, including tachycardia, hypotension and anaphylaxis, and fatal outcomes have occurred in patients with underlying cardiac disease; use with caution and monitor such patients. Antimuscarinic effects (dry mouth, blurred vision, urinary retention) may occur. Unexplained persistent abdominal pain should be investigated.

Pregnancy

Avoid in pregnancy unless clearly necessary.

Storage and supply

Store below 25–30 °C, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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