Omeprazole Capsules – Complete Drug Monograph,
1. Active Ingredient / Formula
Generic Name: Omeprazole
Chemical Name: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
Molecular Formula: C₁₇H₁₉N₃O₃S
Molecular Weight: 345.42 g/mol
Common Capsule Strengths:
- Omeprazole 10 mg
- Omeprazole 20 mg
- Omeprazole 40 mg
Formulation Components (Excipients):
- Sugar spheres
- Hypromellose
- Glyceryl monostearate
- Titanium dioxide
- Methacrylic acid copolymer
- Sodium lauryl sulfate
- Talc
- Gelatin (capsule shell)
2. Indications (Uses)
Omeprazole is a proton pump inhibitor (PPI) used for:
- Gastroesophageal Reflux Disease (GERD)
- Erosive Esophagitis (healing and maintenance)
- Duodenal Ulcers
- Gastric Ulcers
- Zollinger-Ellison Syndrome
- Helicobacter pylori eradication (in combination with antibiotics)
- NSAID-associated ulcer prevention and treatment
- Hypersecretory conditions
3. Warnings and Precautions
Major Warnings:
- Long-term use (more than 1 year) may cause:
- Vitamin B12 deficiency
- Hypomagnesemia
- Bone fractures (hip, wrist, spine)
- Chronic kidney disease (CKD)
- Dementia risk (controversial, see research)
- Clostridium difficile-associated diarrhea (CDAD) risk increases due to altered gut flora.
- Lupus erythematosus (cutaneous or systemic) has been reported.
- Rebound acid hypersecretion after discontinuation.
Drug Interactions:
- Clopidogrel: Reduced antiplatelet effect due to CYP2C19 inhibition.
- Warfarin, diazepam, phenytoin: Increased blood levels.
- Methotrexate: Delayed clearance.
- HIV drugs (e.g., atazanavir): Reduced absorption.
Pediatric Use: Approved for children >1 year with GERD or erosive esophagitis.
Pregnancy Category: Category C (use if benefits outweigh risks).
Lactation: Caution advised; omeprazole is excreted in breast milk.
4. Benefits
- Highly effective acid suppression: Controls symptoms and promotes healing.
- Improved quality of life: Especially in GERD and ulcer patients.
- Used in H. pylori eradication regimens to prevent recurrence.
- Prevention of ulceration in high-risk NSAID users.
New Research & Updates (2024–2025)
A. Microbiome Impact Studies (2024)
- New meta-analysis links long-term PPI use with significant changes in gut microbiota, increasing susceptibility to enteric infections.
- Probiotics co-administration has been shown to reduce dysbiosis.
B. Cognitive Function and Dementia Risk
- A 2025 European cohort study found no strong evidence that PPIs, including omeprazole, increase dementia risk after adjusting for comorbidities. This contradicts earlier observational concerns.
C. Bone Health
- New clinical trials suggest calcium citrate supplementation may reduce fracture risk during long-term omeprazole use.
D. Pharmacogenomics
- CYP2C19 genotype testing is now increasingly recommended to tailor omeprazole dosing.
- Poor metabolizers: Higher drug exposure, risk of toxicity.
- Ultrarapid metabolizers: Reduced efficacy — may require higher doses or alternative PPIs.
E. Formulation Innovation
- In 2025, dual-release omeprazole capsules (combining immediate and delayed release granules) showed better acid suppression in night-time GERD compared to standard once-daily dosing.
Summary Table
| Aspect | Details |
|---|---|
| Active Ingredient | Omeprazole (C₁₇H₁₉N₃O₃S) |
| Main Use | Acid suppression in GERD, ulcers, and Zollinger-Ellison syndrome |
| Onset of Action | 1 hour; peak effect in 2–3 hours |
| Duration | 24 hours (once-daily dosing) |
| Safety Notes | Monitor B12, magnesium, renal function, and bone health in long-term use |
| New Research | Focus on microbiome, pharmacogenomics, dual-release formulations |
