Schedule H

Oral, Intravenous

• Tablets: 75 mg, 150 mg

• Injection: 75 mg/2 mL ampoule (IV use only)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

◾ 1. Peptic Ulcer Disease (Gastric and Duodenal Ulcers)

Oral Administration:

Parameter Recommendation

Starting dose 150 mg once daily at bedtime OR 75 mg twice daily

Titration Not applicable

Usual maintenance dose 75 mg once daily at bedtime (for ulcer recurrence prevention)

Maximum dose 300 mg/day

Clinical Notes:

• Treatment duration: 4–8 weeks depending on ulcer type and healing

• Once-daily bedtime dosing preferred for improved compliance

• Confirm H. pylori status and eradicate if positive

Parenteral Administration (Acute Inpatient Setting):

Parameter Recommendation

Starting dose 75 mg IV every 12 hours

Titration Not applicable

Usual maintenance dose 75 mg IV every 12 hours

Maximum dose 150 mg/day IV

Clinical Notes:

• Reserved for patients unable to take oral medications (e.g., bleeding ulcer, post-surgery)

• Switch to oral therapy as soon as clinically feasible

◾ 2. Gastroesophageal Reflux Disease (GERD)

Parameter Recommendation

Starting dose 75 mg twice daily

Titration May increase to 150 mg twice daily for inadequate symptom control

Usual maintenance dose 75 mg once daily at bedtime

Maximum dose 300 mg/day

Clinical Notes:

• Treatment duration: 4–8 weeks for symptom control

• Less effective than PPIs for erosive esophagitis; reserve for mild GERD or PPI-intolerant patients

• Consider step-up to PPI if inadequate response after 4 weeks

◾ 3. Stress Ulcer Prophylaxis (Hospitalised/ICU Patients)

IV route only — Specialist/Critical care use

Parameter Recommendation

Starting dose 75 mg IV every 12 hours

Titration Adjust based on clinical risk and institutional protocol

Usual maintenance dose 75 mg IV every 12 hours

Maximum dose 150 mg/day IV

Clinical Notes:

• Short-term use during critical care admission

• Transition to oral therapy or discontinue when risk factors resolved

• PPIs generally preferred where available

Secondary Indications – Adults (Off-label, if any)

Indication Dose Duration Notes

NSAID-induced dyspepsia/ulcer prophylaxis 75 mg twice daily orally As long as NSAID therapy continues OFF-LABEL — Used in high-risk patients without access to PPI; extrapolated from H2RA class evidence and Indian clinical practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications – Paediatric

◾ Peptic Ulcer Disease (Gastric/Duodenal Ulcer)

Specialist use only — Limited Indian data

≥12 years Adult dosing applies — 300 mg/day

6–12 years 2–4 mg/kg/day Divided into 1–2 doses 150 mg/day

Parameter Recommendation

Starting dose 2 mg/kg/day in 1–2 divided doses

Titration May increase to 4 mg/kg/day based on response

Usual maintenance dose 2–3 mg/kg/day

Maximum dose 150 mg/day

Clinical Notes:

• Treatment duration: 4–8 weeks

• Use under paediatric gastroenterologist supervision

• Confirm ulcer etiology before initiating therapy

Secondary Indications – Paediatric (Off-label, if any)

Indication Dose Duration Notes

GERD 2–3 mg/kg/day in divided doses 4–6 weeks OFF-LABEL — Paediatric gastroenterologist supervision required; PPIs preferred as first-line

Minimum Age Recommendation:

• Not recommended below 6 years except under paediatric gastroenterologist supervision

• Limited paediatric safety and efficacy data in Indian population

Safety Monitoring:

• Monitor for sedation and CNS effects

• Assess GI symptom response

• Periodic renal function in prolonged use

50 mL/min No adjustment required

30–50 mL/min 75 mg once daily

10–30 mL/min 75 mg every 36–48 hours

<10 mL/min Avoid or use 75 mg every 48 hours with close monitoring

Haemodialysis Consider post-dialysis dosing; limited data available

Peritoneal dialysis Limited data; specialist input advised

Note: Monitor for CNS adverse effects (confusion) in renally impaired patients

• Known hypersensitivity to roxatidine or any formulation component

• Acute porphyria

• Known hypersensitivity to other H2-receptor antagonists (cross-reactivity possible)

• Chronic kidney disease — dose adjustment required to prevent accumulation

• Elderly patients — increased susceptibility to CNS effects (confusion, agitation)

• Prolonged therapy without endoscopic evaluation — may mask symptoms of gastric malignancy

• Concurrent CNS depressants in elderly — enhanced sedation risk

• History of cardiac arrhythmias — caution with IV administration

• Risk of rebound acid hypersecretion on abrupt discontinuation after prolonged use

Parameter Details

Risk category Limited human data; animal studies show no teratogenicity

Preferred alternatives Famotidine (more safety data); PPIs (omeprazole, pantoprazole) if acid suppression essential

When may be used Only when clearly indicated and benefit outweighs potential risk

Monitoring Maternal symptom resolution; routine fetal growth monitoring if prolonged use

Parameter Details

Breastfeeding compatibility Generally compatible; excreted in breast milk in low quantities

Expected drug levels in milk Low

Preferred alternatives Famotidine if concern about infant exposure

Infant monitoring Feeding pattern, irritability, GI symptoms with prolonged maternal use

Parameter Recommendation

Starting dose 75 mg once daily

Titration Slower titration; assess renal function before any dose increase

Special risks Increased CNS sensitivity (confusion, agitation, hallucinations); reduced renal reserve; falls risk with high doses

Additional considerations Baseline renal function assessment mandatory; prefer lower effective dose

Interacting Drug Effect Management

Atazanavir Significantly reduced atazanavir absorption (pH-dependent) Avoid co-administration

Itraconazole (capsules) Reduced antifungal absorption due to elevated gastric pH Avoid combination; if essential, use itraconazole solution

Rilpivirine Reduced antiretroviral bioavailability Avoid combination

Interacting Drug Effect Management

Ketoconazole Reduced absorption due to increased gastric pH Space doses by at least 2 hours; administer ketoconazole with acidic beverage

Iron salts Reduced iron absorption Stagger administration by 2 hours

Sucralfate May reduce roxatidine absorption Administer roxatidine at least 2 hours before sucralfate

Warfarin Possible minor INR fluctuations Monitor INR during initiation

QT-prolonging agents (erythromycin, fluoroquinolones) Potential additive effect on cardiac conduction ECG monitoring in high-risk patients (elderly, ICU setting)

• Headache

• Dizziness

• Constipation or diarrhoea

• Fatigue and somnolence

• Dry mouth

• Nausea

• Abdominal discomfort

Adverse Effect Clinical Action

Confusional states/Hallucinations (especially elderly or renal impairment) Reduce dose or discontinue; usually reversible

Hepatic enzyme elevation/Hepatitis (rare) Discontinue; monitor LFTs

Hypersensitivity reactions (rash, urticaria, anaphylaxis — rare) Discontinue immediately

Thrombocytopenia (rare) Discontinue; haematology review

Haemolytic anaemia (rare) Discontinue; supportive care

Cardiac arrhythmias (with rapid IV infusion) Use slow IV infusion; ECG monitoring

Phase Parameters

Baseline Renal function (serum creatinine, eGFR); LFTs if prolonged use anticipated; symptom assessment

After initiation Symptom response at 2–4 weeks; mental status in elderly; signs of GI bleeding

Long-term (>4 weeks) CBC periodically; renal function in elderly/CKD; reassess need for continued therapy

• Roxil® (Zuventus)

• Roxigut® (Lupin)

• Roxane® (Micro Labs)

• Rotec® (Alkem)

• Generic formulations from various manufacturers

Note: No commonly used FDCs with roxatidine

Note: Not listed under NLEM; not under NPPA price control; private pricing varies

1. Alternative to PPIs — Useful option in patients with PPI intolerance, PPI-associated adverse effects, or concerns about long-term PPI use

1. Minimal CYP450 interactions — Advantage over cimetidine in polypharmacy settings; fewer drug-drug interactions

1. CNS effects in vulnerable populations — Start with lower doses in elderly and renally impaired patients; confusion is dose-related and reversible

1. Less effective for erosive disease — Reserve for mild GERD or ulcer prophylaxis; PPIs preferred for erosive esophagitis and severe GERD

1. Short-term stress ulcer prophylaxis — Reasonable option in ICU when IV PPI not available; transition to oral therapy early

1. Rule out malignancy — Symptomatic improvement may mask underlying gastric carcinoma; endoscopic evaluation indicated for persistent or alarming symptoms

Roxatidine; H2 blocker; H2 receptor antagonist; acid suppression; peptic ulcer disease; GERD; stress ulcer prophylaxis; renal-adjustment; elderly-caution; pregnancy-compatible; PPI-alternative

RxIndia v1.0 — 03 May 2025

• CDSCO approved prescribing information

• IP/NFI (Indian Pharmacopoeia / National Formulary of India)

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• AIIMS Drug Formulary

• Standard Indian clinical practice — Internal Medicine and Gastroenterology