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Authoritative Clinical Reference
Schedule H
Oral, Intravenous (IV)
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Parameter Dose
Starting dose 40 mg orally once daily (30–60 minutes before breakfast)
Titration Not typically required; if inadequate response after 4 weeks, evaluate for complications or alternative diagnosis
Usual maintenance dose 20–40 mg once daily
Maximum dose 40 mg twice daily (specialist discretion for refractory cases)
Duration:
Clinical Notes:
Duodenal Ulcer:
Parameter Dose
Starting dose 40 mg orally once daily
Titration Not applicable
Usual maintenance dose 40 mg once daily
Maximum dose 40 mg once daily
Duration: 4 weeks (may extend to 8 weeks if not healed)
Gastric Ulcer:
Parameter Dose
Starting dose 40 mg orally once daily
Titration Not applicable
Usual maintenance dose 40 mg once daily
Maximum dose 40 mg once daily
Duration: 4–8 weeks
Clinical Notes:
Parameter Dose
Starting dose 40 mg orally twice daily
Titration Not applicable
Usual maintenance dose 40 mg twice daily
Maximum dose 40 mg twice daily
Standard Triple Therapy Regimen (14 days):
Alternative (Bismuth Quadruple Therapy — 14 days):
Clinical Notes:
Parameter Dose
Starting dose 40 mg orally once daily
Titration Not applicable
Usual maintenance dose 40 mg once daily (healing); 20–40 mg once daily (maintenance)
Maximum dose 40 mg twice daily (severe cases)
Duration:
PAEDIATRIC DOSING (Specialist Only)
⚠️ Not recommended in children below 5 years of age except under specialist supervision. Limited paediatric data available.
Primary Indications: GERD, Erosive Esophagitis
Oral Dosing (Children ≥5 years):
Weight Dose Frequency Duration
15–40 kg 20 mg once daily Once daily (before breakfast) 8 weeks
40 kg 40 mg once daily Once daily (before breakfast) 8 weeks
Parameter Dose
Starting dose Weight-based as above
Titration Not typically required
Usual maintenance dose 20–40 mg once daily based on weight
Maximum dose 40 mg once daily
Intravenous Dosing (Hospital Setting — Limited Data):
Safety Monitoring:
Clinical Notes:
Secondary Indications – Paediatrics (Off-label)
Indication Age Dose Duration Supervision Evidence Basis
Stress Ulcer Prophylaxis in PICU (OFF-LABEL) ≥1 year 0.5–1 mg/kg IV once daily (maximum 40 mg) Duration of ICU risk factors Specialist only (PICU) Extrapolated from adult data; IAP protocols
Zollinger-Ellison Syndrome (OFF-LABEL) ≥5 years Individualised dosing based on acid output; starting 0.5–1 mg/kg twice daily Long-term Specialist only (Paediatric GI) Case reports; extrapolated from adult data
Age Restrictions:
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| eGFR (ml/min/1.73m²) | Recommendation |
Mild to Severe Impairment No dose adjustment required
Haemodialysis No supplemental dose required; not significantly dialysed
Peritoneal Dialysis No dose adjustment required
Note: Pantoprazole is primarily hepatically metabolised; renal excretion of unchanged drug is minimal.
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | Use lowest effective dose; maximum 40 mg/day; monitor for adverse effects |
| Severe impairment (Child-Pugh C) | Maximum 20 mg once daily or 40 mg every other day; hepatology input advised; avoid prolonged or high-dose therapy |
Note: Pantoprazole half-life is prolonged in hepatic impairment; accumulation possible with repeated dosing.
Parameter Information
Overall Safety Limited human data; animal studies show no teratogenicity; generally considered acceptable when indicated
Risk No confirmed teratogenic risk in humans; considered safer than untreated severe GERD
Preferred Alternatives Omeprazole (most human pregnancy data available among PPIs); antacids or H2 blockers for mild symptoms
When Use May Be Justified Moderate to severe GERD unresponsive to lifestyle modifications and antacids; erosive esophagitis; use at lowest effective dose for shortest duration
Monitoring Maternal symptom control; no specific fetal monitoring required
Parameter Information
Compatibility Likely compatible; very low levels expected in breast milk based on pharmacokinetic properties
Expected Drug Level in Milk Very low (pantoprazole is highly protein-bound and acid-labile)
Preferred Alternatives Omeprazole (more breastfeeding data available); famotidine (H2 blocker)
Infant Monitoring Monitor for GI disturbances (diarrhoea, constipation), feeding difficulties, weight gain (rare concerns)
Recommendation Generally acceptable for short-term use during breastfeeding
Parameter Recommendation
Starting dose 20–40 mg once daily (same as adults; consider starting at 20 mg)
Titration Not typically required; use lowest effective dose
Maximum recommended 40 mg once daily for most indications; avoid high doses unless clearly indicated
Increased Risks Increased fracture risk (hip, spine, wrist); hypomagnesaemia (especially with concurrent diuretics); vitamin B12 deficiency with long-term use; Clostridioides difficile infection; pneumonia (community-acquired)
Additional Precautions Review indication periodically; de-escalate or discontinue when possible; ensure adequate calcium, vitamin D, and B12 intake; monitor magnesium levels if on long-term therapy or diuretics
Interacting Drug Mechanism Effect Management
Rilpivirine Reduced gastric acidity decreases rilpivirine absorption Significant reduction in rilpivirine levels; risk of HIV treatment failure and resistance Contraindicated — avoid combination
Atazanavir Reduced gastric acidity decreases atazanavir absorption Significantly reduced atazanavir levels; risk of HIV treatment failure Contraindicated — avoid combination; if unavoidable, use atazanavir/ritonavir 400/100 mg with food, PPI ≤20 mg, and administer simultaneously
Methotrexate (high-dose) Possible inhibition of renal tubular secretion of methotrexate Increased methotrexate levels and toxicity risk Consider temporary PPI discontinuation during high-dose methotrexate therapy; monitor methotrexate levels
Clopidogrel CYP2C19 inhibition (minimal with pantoprazole) Potential reduction in active clopidogrel metabolite (less significant than with omeprazole/esomeprazole) Pantoprazole preferred PPI if PPI required with clopidogrel; cardiology input if recent ACS/PCI
Interacting Drug Effect Management
Warfarin Variable reports of increased INR Monitor INR when initiating or discontinuing pantoprazole; adjust warfarin dose as needed
Digoxin Increased digoxin absorption due to elevated gastric pH Monitor digoxin levels, especially in elderly or those with renal impairment; risk higher if hypomagnesaemia present
Iron supplements (ferrous salts) Reduced iron absorption due to elevated gastric pH Take iron supplement with food or vitamin C; consider parenteral iron if deficiency persists
Ketoconazole, Itraconazole, Posaconazole Reduced antifungal absorption (requires acidic environment) Separate dosing; use antifungals that do not require acidic pH (fluconazole, voriconazole); or administer with acidic beverage
Vitamin B12 Reduced absorption with long-term PPI use Monitor B12 levels annually in long-term users; supplement if deficient
Mycophenolate mofetil Reduced absorption of mycophenolic acid (enteric-coated formulation) Monitor mycophenolate levels and clinical efficacy; consider mycophenolate sodium if clinically appropriate
Bisphosphonates (oral) No direct interaction but additive bone risk Ensure adequate calcium and vitamin D; monitor bone health in long-term concurrent use
Tacrolimus Possible increased tacrolimus levels Monitor tacrolimus trough levels when initiating or discontinuing PPI
Adverse Effect Clinical Action
Clostridioides difficile-associated diarrhoea (CDAD) Discontinue PPI; test for C. difficile toxin; treat as per guidelines; consider alternative acid suppression if essential
Hypomagnesaemia (may cause tetany, arrhythmias, seizures) Check magnesium levels; discontinue PPI; supplement magnesium; may recur on rechallenge
Acute Interstitial Nephritis Discontinue immediately; nephrology referral; usually reversible but may progress to chronic kidney disease
Vitamin B12 Deficiency (with long-term use) Monitor annually in long-term users; supplement if deficient
Bone Fractures (hip, spine, wrist — with long-term high-dose use) Use lowest effective dose; ensure calcium and vitamin D adequacy; bone density monitoring in high-risk patients
Subacute Cutaneous Lupus Erythematosus (SCLE) (rare) Discontinue PPI; dermatology referral; rash usually resolves after discontinuation
Fundic Gland Polyps (benign; with long-term use) Usually benign; endoscopic surveillance as per GI practice; often regress after PPI discontinuation
Anaphylaxis / Angioedema (rare) Discontinue permanently; emergency management
Severe Skin Reactions (SJS/TEN) (very rare) Discontinue immediately; hospitalisation; dermatology consultation
| Timing | Parameters |
|---|---|
| Baseline | Evaluate for alarm symptoms (dysphagia, weight loss, GI bleeding, persistent vomiting) — endoscopy if indicated; serum magnesium if on diuretics or long-term PPI therapy |
Short-term use (<8 weeks) No routine monitoring required
Long-term use (>8–12 weeks) Serum magnesium (especially if on diuretics, digoxin); vitamin B12 annually; reassess indication for continued PPI use
If on warfarin INR monitoring when initiating or stopping PPI
If on digoxin Digoxin levels, especially if hypomagnesaemia suspected
Zollinger-Ellison Syndrome Gastric acid output measurements; serum gastrin levels periodically
Tablets (20 mg, 40 mg):
Injection (40 mg):
Fixed-Dose Combinations (Examples):
| Brand Name | Composition | Manufacturer |
|---|---|---|
| * | Pantoprazole + Domperidone (e.g., Pantocid-D, Pan-D) — commonly used but monitor for QT prolongation with | domperidone |
| * | Pantoprazole + Itopride (e.g., | Pantocar-IT) |
⚠️ Note on Domperidone FDCs: Monitor for QT prolongation risk, especially in elderly, cardiac patients, or those on other QT-prolonging drugs. Domperidone dose should not exceed 30 mg/day.
| Formulation | Approximate Price (per tablet) |
|---|---|
| 20 mg tablet ₹1.50–₹5.00 per tablet NLEM listed | |
| 40 mg tablet ₹2.50–₹10.00 per tablet NLEM listed | |
| 40 mg injection ₹35–₹100 per vial — | |
| FDCs (Pantoprazole + Domperidone) ₹4–₹12 per tablet — |
Regulatory: Listed under NLEM 2022 (40 mg tablet); NPPA price controlled for scheduled strengths
PPI; acid-peptic-disease; GERD; peptic-ulcer; H-pylori; NLEM-India; CYP2C19-minimal; renal-safe; pregnancy-acceptable; clopidogrel-compatible; stress-ulcer-prophylaxis; Schedule-H
RxIndia v1.0 — 28 Apr 2025
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