schedule H

Oral, Intravenous

Form Available Strengths

Capsules (Enteric-coated) 10 mg, 20 mg, 40 mg

Tablets (Enteric-coated) 10 mg, 20 mg, 40 mg

Powder for Injection (IV) 40 mg vial

Oral Suspension (reconstituted) 2 mg/mL (prepared from sachets)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Gastroesophageal Reflux Disease (GERD)

Parameter Recommendation

Starting dose 20 mg orally once daily, 30–60 minutes before breakfast

Titration Increase to 40 mg/day if inadequate response after 4 weeks

Usual maintenance dose 10–20 mg once daily

Maximum dose 40 mg/day

Duration 4–8 weeks for healing; reassess need beyond 8 weeks

1. Peptic Ulcer Disease — Duodenal Ulcer

Parameter Recommendation

Starting dose 20 mg orally once daily

Titration Increase to 40 mg/day in refractory cases

Usual maintenance dose 20 mg once daily

Maximum dose 40 mg/day

Duration 4 weeks (extend to 8 weeks if not healed)

1. Peptic Ulcer Disease — Gastric Ulcer

Parameter Recommendation

Starting dose 20 mg orally once daily

Titration Increase to 40 mg/day in refractory cases

Usual maintenance dose 20–40 mg once daily

Maximum dose 40 mg/day

Duration 8 weeks

Clinical Note: Rule out gastric malignancy before initiating therapy in patients with alarm features.

1. Helicobacter pylori Eradication (Triple Therapy)

Component Dose Frequency Duration

Omeprazole 20 mg Twice daily 14 days

Clarithromycin 500 mg Twice daily 14 days

Amoxicillin 1000 mg Twice daily 14 days

Alternative (Penicillin allergy):

Component Dose Frequency Duration

Omeprazole 20 mg Twice daily 14 days

Clarithromycin 500 mg Twice daily 14 days

Metronidazole 400 mg Twice daily 14 days

Parameter Recommendation

Starting dose 20 mg twice daily

Titration Not applicable

Usual maintenance dose Not applicable (fixed regimen)

Maximum dose 20 mg twice daily

1. Zollinger-Ellison Syndrome

Parameter Recommendation

Starting dose 60 mg orally once daily

Titration Adjust based on gastric acid output; increase by 20 mg increments

Usual maintenance dose 60–120 mg/day (divide BID if >80 mg/day)

Maximum dose 180 mg/day in divided doses

Note Specialist supervision mandatory; lifelong therapy often required

1. NSAID-induced Ulcer Prophylaxis

Parameter Recommendation

Starting dose 20 mg orally once daily

Titration Not applicable

Usual maintenance dose 20 mg once daily

Maximum dose 20 mg/day

Duration Continue as long as NSAID therapy in at-risk patients

At-risk patients: Age >65 years, prior GI bleed, concurrent corticosteroid/anticoagulant use, high-dose NSAIDs.

1. Stress Ulcer Prophylaxis (ICU/Hospitalised Patients)

Parameter Recommendation

Starting dose (IV) 40 mg IV once daily

Titration Not applicable

Usual maintenance dose 40 mg IV once daily

Maximum dose 40 mg/day IV

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. GERD and Erosive Oesophagitis

Weight/Age Dose Frequency Duration

10–20 kg (≥1 year) 10 mg orally Once daily 4–8 weeks

20 kg (≥1 year) 20 mg orally Once daily 4–8 weeks

Adolescents (≥12 years) 20 mg orally Once daily 4–8 weeks

Parameter Recommendation

Starting dose Weight-based as above

Titration May increase to 20 mg (10–20 kg) or 40 mg (>20 kg) if inadequate response

Maximum dose 40 mg/day (short-term)

1. Peptic Ulcer Disease (Paediatric)

Parameter Recommendation

Dose 0.7–3.3 mg/kg/day orally in single or divided doses

Maximum dose 40 mg/day

Duration 4–8 weeks

Note Specialist/paediatric gastroenterologist supervision

Secondary Indications — Paediatrics (Off-label)

Indication Age Dose Duration Notes

H. pylori eradication ≥5 years 1 mg/kg twice daily (max 20 mg BID) with antibiotics 14 days OFF-LABEL; IAP-recognised practice; paediatric GI specialist

Paediatric Safety Notes

Parameter Recommendation

Minimum age ≥1 year for standard indications

Infants <1 year NOT RECOMMENDED except under paediatric gastroenterologist supervision

Safety concerns in infants Risk of enteric infections, altered gut microbiome, possible increased respiratory infections

Monitoring Clinical response; discontinue if no clear benefit after 4 weeks

Long-term use Avoid unless essential; reassess periodically

Renal Function Dose Modification

Note: Omeprazole is extensively hepatically metabolised; accumulation may occur in severe liver disease.

• Known hypersensitivity to omeprazole, other substituted benzimidazoles (esomeprazole, pantoprazole, etc.), or any formulation excipient

• Concurrent use with rilpivirine (pH-dependent absorption reduced → virological failure)

• Concurrent use with nelfinavir (significantly reduced nelfinavir exposure)

• Prolonged therapy (>8–12 weeks): Risk of vitamin B12 deficiency, hypomagnesaemia, enteric infections

• History of osteoporosis or fragility fractures: Use lowest effective dose; monitor bone health

• Patients with alarm symptoms (dysphagia, weight loss, GI bleeding, anaemia): Rule out malignancy before starting

• Concurrent clopidogrel therapy: Possible reduced antiplatelet efficacy (CYP2C19 interaction)

• Elderly patients: Increased risk of Clostridioides difficile infection, fractures, hyponatraemia

• Patients on high-dose or multiple daily dosing: Monitor magnesium levels

• SLE patients: Reports of subacute cutaneous lupus erythematosus exacerbation

Parameter Recommendation

Overall safety Generally considered compatible; most data support safety in 2nd and 3rd trimesters

First trimester Limited data; no definitive evidence of teratogenicity; use if clearly indicated

Preferred alternatives Pantoprazole (slightly more familiarity in Indian obstetric practice); antacids for mild symptoms

When to use Severe GERD, peptic ulcer disease unresponsive to lifestyle measures/antacids

Monitoring Standard antenatal care; symptom control assessment

Parameter Recommendation

Compatibility Compatible with breastfeeding at standard doses

Drug levels in milk Low (milk:plasma ratio approximately 0.05–0.3)

Preferred alternatives Pantoprazole (also acceptable); famotidine for short-term use

Infant monitoring Weight gain, GI symptoms (diarrhoea, colic) if prolonged maternal use

Parameter Recommendation

Starting dose 10 mg once daily for mild symptoms; 20 mg once daily for moderate-severe

Titration Slow; increase only if inadequate response after 4 weeks

Maximum dose 40 mg/day (same as adults)

Extra risks Hyponatraemia, vitamin B12 deficiency, hypomagnesaemia, hip/vertebral fractures, C. difficile infection

Duration Limit to shortest effective duration; reassess need every 3–6 months

Interacting Drug Effect Recommendation

Clopidogrel Reduced antiplatelet effect (CYP2C19 inhibition reduces active metabolite formation) Avoid combination; use pantoprazole or rabeprazole as alternative PPI

Rilpivirine Reduced rilpivirine absorption (pH-dependent) → HIV treatment failure Contraindicated

Atazanavir Reduced atazanavir absorption → treatment failure Avoid combination; if essential, use boosted atazanavir with adjusted dosing

Nelfinavir Significantly reduced nelfinavir exposure Contraindicated

High-dose Methotrexate Reduced renal clearance of methotrexate → toxicity Avoid if possible; if unavoidable, monitor methotrexate levels closely; consider temporary PPI discontinuation

Citalopram/Escitalopram Additive QT prolongation risk Monitor ECG if combination unavoidable

Mechanism: Omeprazole is a CYP2C19 inhibitor (strong) and CYP3A4 inhibitor (weak).

Interacting Drug Effect Recommendation

Warfarin May increase INR (reduced warfarin metabolism) Monitor INR closely, especially on initiation/discontinuation

Phenytoin Increased phenytoin levels (CYP2C19 inhibition) Monitor phenytoin levels; adjust dose if needed

Digoxin Increased digoxin absorption (reduced gastric acidity) Monitor for digoxin toxicity, especially in elderly

Diazepam Prolonged diazepam effect (reduced metabolism) Monitor for excessive sedation

Oral iron supplements Reduced iron absorption (increased gastric pH) Separate administration by 2–3 hours; consider IV iron if refractory anaemia

Vitamin B12 (oral) Reduced absorption with prolonged PPI use Monitor B12 levels in long-term users; supplement if deficient

Calcium carbonate Reduced calcium absorption Consider calcium citrate instead for osteoporosis patients

Ketoconazole/Itraconazole Reduced azole absorption (pH-dependent) Avoid combination; use fluconazole if antifungal needed

Mycophenolate mofetil Reduced mycophenolic acid exposure Monitor immunosuppression efficacy

Tacrolimus Possibly increased tacrolimus levels Monitor tacrolimus levels

• Headache (most common)

• Nausea

• Diarrhoea

• Constipation

• Abdominal pain/bloating

• Flatulence

• Dizziness

• Skin rash (non-serious)

• Dry mouth

• Taste disturbance

Adverse Effect Clinical Notes

Clostridioides difficile–associated diarrhoea Discontinue PPI; test for toxin; treat infection

Severe hypomagnesaemia Usually with prolonged use (>3 months); may cause tetany, seizures, arrhythmias; check levels periodically

Vitamin B12 deficiency Risk increases with duration >2–3 years; monitor and supplement

Acute interstitial nephritis Rare; presents with AKI, eosinophilia; requires immediate discontinuation

Osteoporotic fractures Hip, wrist, vertebral; risk with long-term high-dose use; use lowest effective dose

Stevens-Johnson syndrome/TEN Very rare; discontinue immediately; hospitalisation required

Subacute cutaneous lupus erythematosus Discontinue; rash may persist weeks after stopping

Fundic gland polyps Benign; with long-term use; usually regress after stopping

At initiation Serum electrolytes (especially if on diuretics); renal function

Short-term (4–8 weeks) Symptom resolution; reassess indication

Long-term (>3 months) Serum magnesium every 6 months

Long-term (>12 months) Vitamin B12 levels annually; bone mineral density in high-risk patients

If on anticoagulants INR monitoring on initiation and dose changes

Brand Name Manufacturer Notes

Omez Dr. Reddy's Most widely used

Ocid Zydus Cadila

Omesec Cipla

Nilsec Mankind

Romesec Ranbaxy/Sun

Omizac Abbott

Omez-D Dr. Reddy's FDC with Domperidone

Omez-DSR Dr. Reddy's FDC with Domperidone SR

FDC combinations available: Omeprazole + Domperidone (common); Triple therapy kits (Omeprazole + Clarithromycin + Amoxicillin/Tinidazole)

NLEM 2022 Status: Included — NPPA price ceiling applicable for scheduled formulations

Jan Aushadhi Availability: Yes — available at subsidised rates through government outlets

1. Timing is critical: Administer 30–60 minutes before the first meal of the day for optimal acid suppression; taking with or after meals significantly reduces efficacy.

1. Step-down approach: After 4–8 weeks of healing, attempt dose reduction or switch to H2 receptor antagonist/antacids; avoid indefinite PPI use without documented indication.

1. Clopidogrel interaction: When dual antiplatelet therapy with PPI is needed, prefer pantoprazole or rabeprazole over omeprazole; the clinical significance remains debated but the interaction is well-documented.

1. Rebound hypersecretion: Abrupt discontinuation after prolonged use (>8 weeks) may cause rebound acid hypersecretion; consider tapering by halving dose for 2–4 weeks before stopping.

1. H. pylori testing: Always test before treating; 14-day triple therapy is now preferred over 7-day regimens in India due to increasing clarithromycin resistance.

1. Not a substitute for lifestyle: Ensure patients understand that weight loss, dietary modification, and avoiding late meals are essential adjuncts, especially for GERD.

proton-pump-inhibitor; PPI; GERD; peptic-ulcer; H-pylori; acid-suppression; stress-ulcer-prophylaxis; renal-safe; clopidogrel-interaction; NLEM-India

RxIndia v1.1 — 30 May 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia (IP)

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine

• ICMR H. pylori Management Guidelines

• AIIMS Drug Formulary

• IAP Paediatric Drug Formulary (paediatric dosing)

• WHO Model Formulary (supportive paediatric data)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics