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Authoritative Clinical Reference
Schedule H
Oral, Intravenous, Intramuscular
⚠️ IMPORTANT REGULATORY NOTICE: Following detection of N-Nitrosodimethylamine (NDMA) impurity, CDSCO issued safety alerts in 2020 resulting in suspension/recall of multiple ranitidine products in India. Availability is significantly restricted. Famotidine is now the preferred H2-receptor antagonist in most Indian hospitals. Only use ranitidine formulations from verified, CDSCO-approved batches that have passed nitrosamine testing.
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India):
Acute Healing:
Parameter Dose Clinical Notes
Starting dose 150 mg orally twice daily OR 300 mg at bedtime Take with or without food
Titration Not applicable Fixed dosing
Usual maintenance dose 150 mg at bedtime (after healing) For ulcer recurrence prevention
Maximum dose 300 mg/day (maintenance); 300 mg twice daily (acute)
Duration Duodenal ulcer: 4 weeks; Gastric ulcer: 6–8 weeks Endoscopy to confirm healing in high-risk patients
Parameter Dose Clinical Notes
Starting dose 150 mg orally twice daily For mild-moderate GERD
Titration May increase to 300 mg twice daily if inadequate response After 2–4 weeks trial
Usual maintenance dose 150 mg twice daily
Maximum dose 600 mg/day in divided doses
Duration 6–12 weeks PPIs preferred for erosive oesophagitis; H2RAs for mild GERD or PPI intolerance
Parameter Dose Clinical Notes
Starting dose 150 mg orally three times daily Higher doses often required
Titration Increase based on gastric acid output and symptom control Titrate in 150 mg increments
Usual maintenance dose 150 mg three to four times daily Individualised dosing
Maximum dose Up to 6 g/day in divided doses Specialist supervision mandatory; PPIs now preferred
Duration Long-term; reassess periodically
Parameter Dose Clinical Notes
Starting dose 150 mg orally twice daily OR 300 mg at bedtime
Titration Not applicable
Usual maintenance dose 150 mg twice daily
Maximum dose 300 mg twice daily
Duration 8–12 weeks Confirm healing endoscopically in high-risk patients; consider PPI for prophylaxis
Intravenous/Intramuscular:
Parameter Dose Clinical Notes
Starting dose 50 mg IV/IM every 6–8 hours Dilute IV dose; infuse over ≥5 minutes
Titration Not applicable
Usual maintenance dose 50 mg every 6–8 hours
Maximum dose 200 mg/day (50 mg every 6 hours)
Alternative Continuous IV infusion: 6.25 mg/hour (150 mg/24 hours) after 50 mg loading dose
Duration Until oral intake resumed or risk resolved; typically 48–72 hours Reassess daily; discontinue when no longer indicated
Note: Enteral nutrition and early oral feeding are preferred over pharmacological prophylaxis where feasible.
Parameter Dose Clinical Notes
Starting dose 150 mg orally night before surgery + 150 mg 2 hours before induction
Alternative (emergency) 50 mg IV slowly Given 45–60 minutes pre-induction
Titration Not applicable Single/double dose regimen
Usual maintenance dose Not applicable
Maximum dose 150 mg × 2 (oral); 50 mg (IV)
Secondary Indications — Adults (Off-label, if any)
Parameter Details
Indication Reduction of gastric acid secretion during acute pancreatitis
Dose 150 mg orally twice daily OR 50 mg IV every 8 hours
Duration 3–7 days; until oral intake tolerated
Specialist only Yes — Gastroenterology/Critical Care
Evidence basis Indian ICU protocols; supportive care measure; limited RCT evidence for outcome benefit
Parameter Details
PAEDIATRIC DOSING (Specialist Only)
Primary Indications:
Age/Weight Dose Frequency Maximum Daily Dose
Neonates (0–28 days) 1.5–2 mg/kg IV Every 8–12 hours 6 mg/kg/day
Infants (1–12 months) 2 mg/kg/dose orally Every 8–12 hours 6 mg/kg/day
Children (1–16 years, <40 kg) 2–4 mg/kg/day orally divided Every 12 hours 150 mg twice daily (300 mg/day)
Adolescents (≥40 kg) 150 mg orally Twice daily 300 mg/day
Dosing Summary:
Age/Weight Dose Frequency Maximum Daily Dose Duration
Children (1–16 years, <40 kg) 2–4 mg/kg/day orally Divided every 12 hours 300 mg/day 4–8 weeks
Adolescents (≥40 kg) 150 mg Twice daily OR 300 mg at bedtime 300 mg/day 4–8 weeks
Age IV Dose Frequency Maximum
Neonates 1.5–2 mg/kg Every 8–12 hours 6 mg/kg/day
Infants and Children 1–2 mg/kg/dose Every 6–8 hours 200 mg/day
Monitoring: Heart rate (especially with IV use in neonates — bradycardia reported); hepatic function with prolonged use.
Secondary Indications — Paediatrics (Off-label, if any)
Anaphylaxis (Adjunctive H2 blockade) — OFF-LABEL
Parameter Details
Indication Adjunct to adrenaline and H1 antihistamines in anaphylaxis
Dose 1 mg/kg IV (max 50 mg) over 5 minutes
Duration Single dose
Specialist only Yes — Emergency/Paediatric critical care
Evidence basis IAP emergency protocols; supportive international guidelines
Not recommended below 1 month of age except under specialist neonatology supervision. Famotidine is increasingly preferred in paediatric practice due to ranitidine availability concerns.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| ≥50 | No adjustment No adjustment |
| 25–50 | 150 mg once daily 50 mg every 12–18 hours |
| 10–25 | 150 mg once daily or every other day 50 mg every 18–24 hours |
| <10 | 150 mg every other day 50 mg every 24 hours |
| Haemodialysis | Administer after dialysis session Ranitidine is partially dialyzable; supplement 50 mg post-HD |
CAPD 150 mg once daily 50 mg every 24 hours
Key Point: Accumulation occurs in renal impairment; increased risk of CNS adverse effects. Monitor for confusion.
| Severity | Recommendation |
|---|---|
| Mild impairment | No dose adjustment required; monitor LFTs |
| Moderate impairment | Use with caution; consider lower end of dose range |
| Severe impairment | Reduce dose; avoid if possible; use under specialist supervision |
Ranitidine is partially hepatically metabolised; accumulation possible in severe hepatic dysfunction.
Aspect Recommendation
Risk category Generally considered safe; extensive human use data
Use in pregnancy May be used when antacids or lifestyle modifications inadequate
Preferred alternatives Famotidine (now preferred due to availability); PPIs (omeprazole, pantoprazole) for severe GERD
When to use Mild-moderate GERD, peptic ulcer; when PPI contraindicated or unavailable
Monitoring Maternal symptom relief; no specific fetal monitoring required
Aspect Recommendation
Compatibility Compatible with breastfeeding
Drug levels in milk Low to moderate (milk:plasma ratio ~1.9–6.7; but absolute amount low)
Preferred alternatives Famotidine (lower milk:plasma ratio ~0.4–1.5)
Recommendations May use during lactation if clinically indicated
Infant monitoring Observe for drowsiness, feeding pattern changes, irritability (rare)
Aspect Recommendation
Starting dose 150 mg once daily (oral) initially
Titration Increase cautiously based on response and tolerance
Special considerations Calculate creatinine clearance; elderly often have occult renal impairment
Extra risks CNS effects (confusion, hallucinations, agitation) — especially with IV use and renal impairment; bradycardia with IV administration
Monitoring Mental status; renal function; cardiac rhythm with IV use
Drug Interaction Management
Atazanavir Ranitidine increases gastric pH → markedly reduced atazanavir absorption → treatment failure Avoid combination; if unavoidable, give atazanavir with ritonavir and ranitidine separated by 12 hours
Delavirdine Reduced delavirdine absorption due to increased gastric pH Avoid combination
Ketoconazole / Itraconazole Reduced azole absorption (pH-dependent) Avoid H2RAs with azoles; if essential, give azole with acidic beverage (cola) and separate dosing by 2 hours
Procainamide Ranitidine inhibits renal tubular secretion → increased procainamide levels → toxicity (arrhythmias) Avoid or reduce procainamide dose; monitor ECG and procainamide levels
Gefitinib / Erlotinib Reduced absorption of TKIs due to increased gastric pH Avoid concurrent use; if essential, separate by several hours
Drug Interaction Management
Warfarin Minor CYP450 interaction; possible increased/decreased INR Monitor INR when starting or stopping ranitidine
Theophylline Possible increased theophylline levels (CYP inhibition) Monitor theophylline levels; reduce dose if toxicity
Metformin Possible increased metformin levels (competition for renal tubular secretion) Monitor for metformin adverse effects; generally not clinically significant
Midazolam Possible increased midazolam levels Monitor for excess sedation
Glipizide Possible increased hypoglycaemic effect Monitor blood glucose
Iron supplements Reduced iron absorption (increased gastric pH) Separate administration by 2 hours
Cyanocobalamin (Vitamin B12) Reduced B12 absorption with prolonged use Monitor B12 levels in long-term therapy
Adverse Effect Clinical Notes
Cardiac arrhythmias / Bradycardia Primarily with rapid IV administration; give IV over ≥5 minutes; monitor ECG in high-risk patients
Hepatotoxicity Cholestatic or hepatocellular; discontinue if jaundice or significant transaminase elevation
Blood dyscrasias Agranulocytosis, thrombocytopenia, pancytopenia — rare; discontinue and investigate if unexplained fever, sore throat, bruising
CNS effects in elderly Confusion, hallucinations, agitation, delirium — particularly with IV use or renal impairment; reversible on discontinuation
Anaphylaxis Rare; discontinue immediately
Interstitial nephritis Rare; presents as fever, rash, eosinophilia, rising creatinine
Gynecomastia With prolonged high-dose therapy; reversible on discontinuation
| Timing | Parameters |
|---|---|
| Baseline | Serum creatinine/eGFR; LFTs if prolonged therapy anticipated; assess for alarm symptoms requiring investigation |
During IV therapy Heart rate and rhythm (especially elderly); infusion site; mental status
Short-term oral therapy (<8 weeks) Clinical response; symptom resolution
Long-term therapy (>8 weeks) LFTs every 6 months; serum B12 and magnesium annually; CBC if symptoms suggestive of dyscrasia; reassess continued need
Note: Many ranitidine brands were recalled or withdrawn following CDSCO safety alerts (2020). Availability is significantly restricted. Verify batch approval status before use.
Historically available brands (check current availability):
| Brand Name | Composition | Manufacturer |
|---|---|---|
| FDC | Note: Previous FDCs with domperidone (e.g., Ranitidine + Domperidone) are largely | withdrawn. |
Preferred Alternative: Famotidine (Famocid, Topcid, Famonext) is now the H2RA of choice in most Indian hospitals due to no nitrosamine concerns.
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablet 150 mg | ₹1–3 per tablet Where available |
| Tablet 300 mg | ₹2–5 per tablet |
| Syrup 75 mg/5 mL (100 mL) | ₹20–50 per bottle Limited availability |
| Injection 50 mg/2 mL | ₹5–20 per ampoule |
ranitidine; H2-receptor antagonist; H2 blocker; peptic ulcer; GERD; stress ulcer prophylaxis; acid suppression; NDMA recall; famotidine alternative; renal-adjust; Schedule H
RxIndia v1.0 — 04 May 2025
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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