NOSPASM 10/MG TAB 30/TAB

Indications

Approved Uses

Symptomatic relief of smooth‑muscle spasm of the gastrointestinal tract (including IBS-related cramping), biliary tract (biliary colic), and genitourinary tract (including renal colic).

Off-Label Uses

Management of excessive secretions in palliative/end-of-life care (e.g., “death rattle”); sometimes used as an antispasmodic adjunct in bowel/endoscopic procedures depending on local practice.

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years: 10 mg orally 3-5 times daily as needed; may increase per response up to 20 mg per dose (max 80 mg/day). Children 6-11 years: 10 mg orally up to 3 times daily (where labeling allows).

Initial Dose

10mg three times daily for Irritable Bowel Syndrome.

Maintenance Dose

10mg three times daily to 20mg four times daily, as needed.

Maximum Dose

100mg per day (for injectable forms); 80mg per day for oral use (20mg 4 times daily).

Children's Dosage

Children 6-12 years: 10mg three times daily for abdominal cramps. Not recommended for children under 6 years.

Dose Adjustment Notes

No routine dose adjustment is established for renal or hepatic impairment; use caution in severe impairment and monitor for anticholinergic adverse effects.

How to Take

Swallow the tablet whole with water; may be taken with or without food. Do not chew or crush.

Side Effects

Common Side Effects

Dry mouth, blurred vision, tachycardia/palpitations, constipation, urinary retention, skin reactions (e.g., rash/urticaria/pruritus), decreased sweating.

Safety & Warnings

Contraindications

Myasthenia gravis; narrow/closed-angle glaucoma; mechanical stenosis/obstruction of the GI tract (including paralytic ileus); megacolon; prostatic hypertrophy with urinary retention; tachyarrhythmia/tachycardia

Warnings & Precautions

Use caution in patients with narrow/closed-angle glaucoma risk, prostatic hypertrophy/urinary retention, GI obstruction/ileus/megacolon, and tachyarrhythmias; advise urgent evaluation for persistent/worsening abdominal pain or red painful eye/visual symptoms; may cause blurred vision affecting driving/operating machinery

Age Restriction

Not recommended for children under 6 years.

Driving Warning

Generally does not cause drowsiness; if you feel dizzy or have blurred vision, avoid driving or operating machinery.

Drug Interactions

Drug Interactions

Additive anticholinergic effects with other anticholinergics (e.g., TCAs/tetracyclics, antihistamines, antipsychotics, amantadine, quinidine, disopyramide); reduced GI prokinetic effect with dopamine antagonists such as metoclopramide; enhanced tachycardia with beta-adrenergic agents

Interaction Severity

Additive anticholinergic effects with other anticholinergics (e.g., TCAs, first-generation antihistamines, antipsychotics) - typically moderate/clinically significant; antagonizes prokinetics such as metoclopramide (reduced GI motility effect) - moderate; may increase tachycardia with beta-agonists - moderate.

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Children

Children 6-12 years: 10mg three times daily for abdominal cramps. Not recommended for children under 6 years.

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime. However, it should not be taken for long periods without investigating the cause of abdominal pain.

Overdose

Symptoms: anticholinergic toxicity (dry mouth, blurred vision/mydriasis, flushing, tachycardia, urinary retention, decreased bowel motility/ileus, agitation/confusion). Management: supportive care, consider activated charcoal if early, treat severe anticholinergic delirium with physostigmine only in selected cases under expert supervision; urgent medical evaluation required

Patient Counseling

Swallow with water (with/without food); use for short-term cramp relief. Possible dry mouth, constipation, blurred vision, dizziness, palpitations-avoid driving if vision is affected. Do not exceed recommended dose; seek medical advice if symptoms persist/worsen, or if severe abdominal pain is accompanied by fever, vomiting, fainting, blood in stool, or urinary retention; consult before use if glaucoma, prostate enlargement/urinary obstruction, or significant heart disease.

Monitoring Requirements

No routine monitoring required for oral use. For parenteral administration, monitor blood pressure and heart rate.

Pharmacology

Mechanism of Action

Peripheral competitive antagonism at muscarinic acetylcholine receptors on smooth muscle, reducing GI/biliary/GU spasm and related pain.

Onset of Action

Oral onset typically within 30-60 minutes (may vary; peak effect can be later).

Duration of Effect

Approximately 3-6 hours.

Bioavailability

Very low oral bioavailability (commonly cited as ~1% due to poor absorption/first-pass), with predominantly local/peripheral action.

Metabolism

Primarily metabolized by hydrolytic cleavage (ester hydrolysis) to inactive metabolites (largely hepatic/enzymatic hydrolysis).

Excretion

Predominantly fecal/biliary excretion; urinary excretion is minimal after oral dosing (only trace amounts of unchanged drug in urine).

Protein Binding

Approximately 4-5% (about 4.4%), mainly to albumin.

Product Information

Available Dosage Forms

Tablet, solution for injection, suppository

Composition per Dose

Each tablet: 10 mg hyoscine butylbromide

Generic Availability

Yes

OTC Alternatives

Peppermint oil (enteric-coated) for IBS-related cramping; mebeverine where available OTC locally; simethicone if bloating/gas predominates.

Gi Condition

IBS

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