Schedule H

Oral

• Tablets: 6 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65 Years

Parameter Recommendation

Starting dose 6 mg orally twice daily, taken before meals

Titration Not applicable — fixed dose regimen; do not escalate due to cardiovascular risk

Usual maintenance dose 6 mg twice daily for 4–6 weeks

Maximum dose 6 mg twice daily (12 mg/day)

Clinical notes:

• Approved exclusively for female patients <65 years with IBS-C

• Assess clinical response at 4–6 weeks; may extend for additional 4–6 weeks if significant improvement observed

• Discontinue if no meaningful symptomatic improvement within first 4–6 weeks

• Do not use in men or patients ≥65 years — risk-benefit profile unfavourable

• Must exclude underlying cardiovascular disease before initiation

Secondary Indications — Adults (Off-label)

Not applicable.

No off-label indications are supported by evidence or used in standard Indian clinical practice.

PAEDIATRIC DOSING (Specialist Only)

Not recommended in children and adolescents (<18 years).

Parameter Recommendation

Safety and efficacy Not established

Use Contraindicated due to lack of paediatric data and potential cardiovascular risk

Secondary Indications — Paediatrics (Off-label)

Not applicable.

• Known hypersensitivity to tegaserod or any excipient

• History of ischaemic cardiovascular disease (myocardial infarction, unstable angina, stroke, transient ischaemic attack)

• History of peripheral vascular disease

• Confirmed or suspected gastrointestinal obstruction, stricture, or ileus

• Symptomatic gallbladder disease or history of cholecystectomy for biliary complications

• History of sphincter of Oddi dysfunction

• History of bowel obstruction or abdominal adhesions causing obstruction

• Moderate to severe hepatic impairment (Child-Pugh B or C)

• Severe renal impairment (eGFR <30 mL/min)

• Male patients (not approved)

• Patients ≥65 years of age

• Cardiovascular risk factors (hypertension, diabetes, hyperlipidaemia, smoking, obesity) — thorough cardiovascular screening mandatory before initiation

• Patients with family history of premature cardiovascular disease

• Pre-existing diarrhoea or history of severe diarrhoea — may worsen

• Elderly patients approaching 65 years — benefits rarely outweigh risks

• Concurrent use of drugs affecting GI motility

• Dehydration risk — monitor if diarrhoea develops

• Not to be used during diarrhoea-predominant phases of IBS

Parameter Details

Overall safety Limited human data; animal studies did not show teratogenicity at therapeutic doses

Risk category Not formally classified; avoid unless absolutely necessary

Preferred alternatives Bulk-forming agents (ispaghula husk), lactulose, polyethylene glycol

When may be used Only if benefit clearly outweighs potential risk and alternatives have failed; specialist input recommended

Monitoring Fetal growth surveillance if used in later pregnancy

Parameter Details

Compatibility Unknown — limited data on excretion in human breast milk

Drug levels in milk Expected to be low based on physicochemical properties

Preferred alternatives Lactulose, polyethylene glycol, ispaghula husk

Infant monitoring Observe for diarrhoea, feeding intolerance, changes in stool pattern

Parameter Recommendation

Recommendation Avoid use in patients ≥65 years

Rationale Increased cardiovascular risk (myocardial infarction, stroke, unstable angina) documented in clinical trials

If absolutely necessary Not recommended even with lower doses; cardiovascular risk does not diminish with dose reduction

Alternative agents Polyethylene glycol, lactulose, lubiprostone (if available), linaclotide

Interacting Drug Effect & Mechanism Management

QT-prolonging drugs (e.g., amiodarone, sotalol, certain antipsychotics, fluoroquinolones) Potential additive risk of cardiac arrhythmias — mechanism unclear but caution advised Avoid combination; if unavoidable, obtain baseline ECG and monitor

Strong CYP450 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital) May reduce tegaserod plasma concentrations and efficacy Avoid combination; consider alternative prokinetics if inducer therapy essential

Laxatives / stimulant cathartics Additive diarrhoeal effect; risk of dehydration and electrolyte disturbances Avoid concurrent use

Interacting Drug Effect Management

SSRIs / SNRIs (e.g., fluoxetine, sertraline, venlafaxine) Overlapping serotonergic activity; potential for increased GI motility and mild serotonergic effects Monitor for excessive diarrhoea and GI discomfort; usually can be used together with monitoring

Anticholinergic drugs (e.g., dicyclomine, oxybutynin, tricyclic antidepressants) Pharmacological antagonism — may reduce prokinetic efficacy of tegaserod Monitor clinical response; may need to avoid combination

Magnesium-containing antacids Additive diarrhoeal risk Use with caution; monitor stool frequency

Proton pump inhibitors No significant pharmacokinetic interaction; overlapping GI side effects possible Safe to co-administer; monitor for diarrhoea

Digoxin Increased GI motility may reduce digoxin absorption Monitor digoxin levels if clinically indicated

• Diarrhoea (most frequent — up to 12%)

• Abdominal pain or cramping

• Flatulence

• Nausea

• Headache

• Dizziness

• Back pain

Adverse Effect Notes

Ischaemic cardiovascular events Myocardial infarction, unstable angina, stroke, transient ischaemic attack — discontinue immediately and refer urgently

Severe diarrhoea May lead to hypovolaemia, electrolyte imbalance, syncope; may require hospitalisation

Gallbladder complications Cholelithiasis, cholecystitis, biliary colic — discontinue and evaluate

Ischaemic colitis Rare; presents with bloody diarrhoea, abdominal pain — discontinue immediately

Suicidal ideation / Depression Rare post-marketing reports; monitor mood changes

After initiation (Week 1–2) Monitor for diarrhoea severity, abdominal pain, signs of dehydration

Ongoing (every 4–6 weeks) Clinical response assessment; blood pressure monitoring; symptom review; review need for continuation; discontinue if no improvement by 4–6 weeks

Long-term Periodic cardiovascular risk re-assessment; avoid prolonged use beyond 12 weeks unless clear sustained benefit

• Tegibs (Sun Pharma)

• Tegod (Dr. Reddy's)

• Tegsar (Intas)

Note: Market availability may vary; verify with current pharmacy/distributor listings

• NLEM status: Not listed under NLEM 2022

• Government supply: Not routinely stocked; limited to specialist prescriptions

1. Restricted population: Use only in women <65 years with confirmed IBS-C who have failed first-line agents (dietary fibre, osmotic laxatives) — not a first-line therapy

1. Cardiovascular screening is mandatory: Thoroughly exclude any history or current evidence of ischaemic heart disease, cerebrovascular disease, or peripheral vascular disease before prescribing

1. Limited duration of therapy: Do not continue beyond 4–6 weeks if no clinical response; avoid prolonged therapy due to cumulative cardiovascular risk

1. Diarrhoea management: Warn patients about sudden-onset diarrhoea; advise adequate hydration and to report severe or bloody diarrhoea immediately

1. Not for IBS-D or mixed IBS: Contraindicated in diarrhoea-predominant IBS; worsens symptoms

1. Alternative prokinetics: Consider prucalopride as a potentially safer alternative 5-HT4 agonist where available

tegaserod; IBS-C; irritable bowel syndrome; prokinetic; 5-HT4 agonist; serotonergic; women-only; cardiac-risk; restricted-use; constipation

RxIndia v1.0 — 10 Apr 2025

• CDSCO product information

• Indian Pharmacopoeia / National Formulary of India

• Goodman & Gilman's Pharmacological Basis of Therapeutics (13th edition)

• API Textbook of Medicine — Functional Gastrointestinal Disorders

• AIIMS Drug Formulary

• Indian clinical protocols on IBS management