Schedule H

Oral, Subcutaneous (rarely used)

• Tablets: 10 mg, 25 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Non-obstructive Urinary Retention (Post-operative / Postpartum / Atonic Bladder)

Parameter Adult Dosing

Starting dose 10–25 mg orally TID

Titration Increase by 10–15 mg per dose every 3–5 days based on clinical response

Usual maintenance dose 10–50 mg orally TID–QID

Maximum dose 200 mg/day (in divided doses)

Clinical Notes:

• Bladder outflow obstruction must be excluded before initiation (ultrasound/post-void residual)

• Response expected within 30–90 minutes of oral dose

• Administer on empty stomach to reduce nausea and enhance absorption

1. Gastroesophageal Reflux with Hypomotility (Select Cases)

Parameter Adult Dosing

Starting dose 5–10 mg orally TID, 1 hour before meals

Titration May increase to 25 mg TID if tolerated

Usual maintenance dose 10–25 mg orally TID–QID

Maximum dose 100 mg/day

Clinical Notes:

• Limited efficacy; rarely used in current Indian practice

• Prokinetics (domperidone, metoclopramide) are preferred first-line agents

• Reserve for refractory cases under specialist guidance

1. Hypotonic Bowel / Paralytic Ileus (Adjunctive Use)

Parameter Adult Dosing

Starting dose 10 mg orally TID

Titration Not applicable

Usual maintenance dose 10–25 mg orally TID

Maximum dose 75 mg/day

Clinical Notes:

• Use only after mechanical obstruction is definitively excluded

• Best initiated under surgical or gastroenterology specialist supervision

• Short-term use preferred

Secondary Indications — Adults (Off-label)

Indication Dose Duration Evidence Basis Notes

Neurogenic bladder (atonic type) 10–50 mg PO TID–QID As per clinical response Limited case series; Indian specialist urology protocols OFF-LABEL; Specialist initiation mandatory; Ensure no obstruction

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Non-obstructive Urinary Retention (Post-operative)

Age Group Dosing Maximum

Children >1 year 0.6–1.2 mg/kg/day orally in 3–4 divided doses 25 mg per single dose

Clinical Notes:

• Monitor for cholinergic excess (excessive salivation, bronchospasm, diarrhoea)

• Mandatory specialist supervision

• Exclude obstruction prior to initiation

Secondary Indications — Paediatrics (Off-label)

Indication Dose Evidence Basis Notes

Hypotonic / Neurogenic bladder 0.2–0.5 mg/kg per dose orally QID Indian paediatric urology specialist practice OFF-LABEL; Obstruction must be excluded; Start with lowest dose; Monitor for bradycardia, hypotension, bronchial secretions, GI distress

Age Restriction:

• Not recommended in infants <1 year except under strict specialist supervision in tertiary care settings

Mild–Moderate impairment No specific dose adjustment required

Severe impairment Use with caution; monitor for cumulative cholinergic effects

Haemodialysis Data not available; use lowest effective dose with close monitoring

• Mechanical urinary tract obstruction

• Mechanical gastrointestinal obstruction

• Baseline bradycardia (HR <50 bpm)

• Significant hypotension

• Active peptic ulcer disease

• Bronchial asthma or COPD with bronchospasm

• Hyperthyroidism with cardiovascular instability

• Epilepsy (uncontrolled)

• Recent bladder or GI surgery (until obstruction excluded)

• Known hypersensitivity to bethanechol or excipients

• Coronary artery disease with unstable angina

• Peritonitis

• Stable cardiac disease (risk of bradycardia, hypotension)

• Parkinson's disease (may exacerbate sialorrhoea and rigidity)

• Elderly patients (heightened sensitivity to cholinergic effects)

• Controlled hyperthyroidism (atrial fibrillation risk)

• Autonomic neuropathy (exaggerated responses possible)

• Mild–moderate renal impairment

• Hiatal hernia or history of reflux oesophagitis

• Vagotonia

• Patients on beta-blockers or other negative chronotropic agents

Parameter Recommendation

Risk category Use only if clearly indicated; no adequate human data

Preferred alternatives Mechanical bladder emptying (catheterisation) preferred postpartum

When may be used Only after ruling out obstructive pathology; benefit must outweigh risk

Monitoring Monitor for uterine irritability if used postpartum; foetal monitoring if used antepartum

Parameter Recommendation

Compatibility Probably compatible (minimal systemic absorption)

Drug levels in milk Low (limited data)

Preferred alternatives Mechanical bladder emptying usually preferred postpartum

Infant monitoring Observe for loose stools, excessive salivation, feeding difficulties

Parameter Recommendation

Starting dose 10 mg once or twice daily

Titration Increase slowly (every 5–7 days); monitor BP and HR at each step

Special risks Increased sensitivity to hypotension, bradycardia, dizziness, falls, confusion, GI upset

Monitoring Close clinical observation at every dose change; BP/HR monitoring essential

Interacting Drug Effect Recommendation

Beta-blockers (propranolol, atenolol) Additive bradycardia and hypotension Avoid combination; if essential, close cardiac monitoring

Anticholinergics (atropine, hyoscine, oxybutynin) Pharmacological antagonism Avoid concurrent use; negates therapeutic effect

Ganglionic blockers Severe additive hypotension Avoid combination

Quinidine Antagonises bethanechol effect Reduced efficacy; avoid if possible

Interacting Drug Effect Recommendation

Cholinesterase inhibitors (neostigmine, pyridostigmine) Additive cholinergic effects Use with caution; monitor for cholinergic excess

Tricyclic antidepressants (amitriptyline) May reduce bethanechol efficacy Monitor response; may need dose adjustment

Disopyramide Anticholinergic effects may oppose bethanechol Monitor therapeutic response

Antihypertensives Additive hypotensive effect Monitor BP; adjust doses if needed

• Abdominal cramps

• Nausea

• Diarrhoea

• Increased salivation

• Flushing

• Sweating

• Dizziness

• Urinary urgency

• Headache

• Lacrimation

Adverse Effect Action Required

Bronchospasm Discontinue immediately; administer bronchodilator; may require atropine

Severe bradycardia / Hypotension Discontinue; supportive care; atropine 0.6–1.2 mg IV as antidote

Syncope Discontinue; evaluate cardiac status

Seizures (rare, overdose) Discontinue; supportive management

Cholinergic crisis Life-threatening; immediate cessation; IV atropine; ICU care

GI bleeding / Perforation (peptic ulcer exacerbation) Discontinue; urgent surgical/gastroenterology consultation

Phase Parameters

Baseline Exclude mechanical obstruction (bladder scan/imaging); assess respiratory status; baseline BP, HR; document peptic ulcer history

After initiation (Days 1–7) BP and HR monitoring; assess voiding pattern; symptom response expected within 1 week

Long-term Monitor for GI intolerance, bronchospasm, hypotension; periodic renal function if prolonged use; document efficacy regularly in neurogenic bladder

Brand Name Manufacturer Formulation

Urotone — Tablets 10 mg, 25 mg

Urotonin — Tablets 25 mg

Myocholine — Tablets 10 mg, 25 mg

No fixed-dose combinations available

• Not under NPPA price control

• Prices vary by brand and region

1. Obstruction exclusion is mandatory — Never prescribe without confirming absence of urinary or GI obstruction; can cause perforation or retention worsening.

1. Respiratory assessment essential — Contraindicated in bronchospastic conditions; always assess asthma/COPD status before initiating.

1. Limited role in GERD — Prokinetics (domperidone, metoclopramide) are preferred in India; reserve bethanechol for specialist-selected refractory cases only.

1. Muscarinic-only activity — Unlike other cholinergics, bethanechol lacks nicotinic receptor activity; fewer CNS and ganglionic side effects.

1. Atropine is the antidote — For severe cholinergic toxicity, IV atropine (0.6–1.2 mg, repeated as needed) is life-saving.

1. Empty stomach administration — Give 1 hour before or 2 hours after meals to optimise absorption and reduce nausea.

bethanechol; muscarinic agonist; urinary retention; neurogenic bladder; parasympathomimetic; postpartum retention; post-operative retention; cholinergic; urology; geriatric caution; India-approved

RxIndia v1.0 — 01 Feb 2026

• CDSCO product inserts

• Indian Pharmacopoeia

• API Textbook of Medicine — Neurogenic bladder management

• AIIMS Prescribing Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian Urology Association practice protocols

• Paediatric neurology and urology specialist protocols (Indian institutions)