EPIRAZOL 20MG CAP

Indications

Approved Uses

Acid-related disorders treated with omeprazole include GERD (including erosive esophagitis), duodenal ulcer, gastric ulcer, and Zollinger-Ellison syndrome; Helicobacter pylori eradication is an approved use when given as part of combination therapy with antibiotics.

Off-Label Uses

Common off-label uses include stress-ulcer prophylaxis in critically ill patients (often via enteral route), laryngopharyngeal reflux, and functional (non-ulcer) dyspepsia; NSAID-ulcer prophylaxis is generally an on-label/standard indication depending on jurisdiction and product labeling.

Dosage & Administration

Dosing by Condition

GERD (symptomatic): 20 mg once daily for 4 weeks; may extend to 8 weeks if needed. Erosive esophagitis: 20 mg once daily for 4-8 weeks. Duodenal ulcer: 20 mg once daily for 4 weeks. Gastric ulcer: 20 mg once daily for 4-8 weeks. H. pylori eradication: 20 mg twice daily for 10-14 days with appropriate antibiotics (per local regimen). Zollinger-Ellison syndrome: start 60 mg once daily and titrate; if total daily dose >80 mg, divide (up to 120 mg/day or higher under specialist care). NSAID-associated ulcer prevention (high-risk): 20 mg once daily while NSAID continues.

Initial Dose

20mg once daily.

Maintenance Dose

20mg once daily

Maximum Dose

120mg daily for Zollinger-Ellison syndrome; doses over 80mg are given in divided doses.

Children's Dosage

Children 1 month to <1 year (5-10kg): 5mg once daily; Children 1 month to <1 year (≥10kg): 10mg once daily; Children 1-16 years (10-20kg): 10mg once daily; Children 1-16 years (>20kg): 20mg once daily; for GERD and maintenance of healing of erosive esophagitis

Dose Adjustment Notes

Renal impairment: no dose adjustment required. Hepatic impairment: consider dose reduction in severe hepatic impairment; for typical indications do not exceed 20 mg/day in severe hepatic dysfunction unless specialist-directed. High-dose therapy (e.g., Zollinger-Ellison): doses >80 mg/day should be given in divided doses.

How to Take

Take orally once daily on an empty stomach, ideally 30-60 minutes before a meal (preferably breakfast). Swallow the capsule whole with water; do not crush or chew. If unable to swallow, the capsule may be opened and the enteric-coated pellets/granules sprinkled on a small amount of soft acidic food (e.g., applesauce) and swallowed immediately without chewing; do not mix with hot food and do not store the mixture.

Side Effects

Common Side Effects

Headache, nausea, diarrhea, abdominal pain, flatulence, constipation, vomiting, dizziness

Side Effect Frequency

Common (1-10%): headache, abdominal pain, diarrhea, nausea/vomiting, flatulence, constipation; Uncommon (0.1-1%): dizziness, insomnia, rash/urticaria, pruritus, peripheral edema, increased liver enzymes

Safety & Warnings

Contraindications

Hypersensitivity to omeprazole/substituted benzimidazoles or excipients; concomitant use with rilpivirine-containing products; concomitant use with nelfinavir.

Warnings & Precautions

Key precautions: evaluate for alarm features/malignancy if indicated (symptom masking); long-term use risks include hypomagnesemia, vitamin B12 deficiency, and osteoporosis-related fractures; increased risk of C. difficile-associated diarrhea; potential for acute interstitial nephritis; possible lupus (SCLE/SLE); interference with chromogranin A testing; and reduced absorption of drugs dependent on gastric acidity.

Age Restriction

Prescription-only; safety and efficacy not established in pediatric patients under 1 month of age; approved for GERD and erosive esophagitis in patients 1 month of age and older.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: clopidogrel (reduced activation), warfarin (↑INR/bleeding risk), high-dose methotrexate (↑levels/toxicity), phenytoin and diazepam (↑levels via CYP2C19 inhibition), digoxin (↑exposure), tacrolimus (↑levels), atazanavir and nelfinavir (reduced antiviral exposure; nelfinavir contraindicated), rilpivirine (contraindicated), and strong CYP inducers such as rifampin and St. John’s wort (↓omeprazole exposure).

Interaction Severity

MAJOR/CONTRAINDICATED: rilpivirine-containing products; nelfinavir (avoid due to reduced antiviral exposure). SIGNIFICANT (avoid or use alternative PPI): clopidogrel (reduced activation via CYP2C19; prefer pantoprazole if PPI needed). MODERATE: warfarin (INR increase-monitor), high-dose methotrexate (possible increased levels-consider holding PPI), atazanavir (reduced absorption-avoid/monitor), tacrolimus (increased exposure-monitor levels), azole antifungals such as ketoconazole/itraconazole (reduced absorption). MINOR: digoxin (possible increased levels, especially with hypomagnesemia), phenytoin (possible increased levels-monitor if used).

Food Interaction

Food can reduce/delay absorption and reduce antisecretory effect; take on an empty stomach 30-60 minutes before a meal (preferably breakfast).

Special Populations

Pregnancy

Not assigned (FDA)

Breastfeeding

Caution

Children

Children 1 month to <1 year (5-10kg): 5mg once daily; Children 1 month to <1 year (≥10kg): 10mg once daily; Children 1-16 years (10-20kg): 10mg once daily; Children 1-16 years (>20kg): 20mg once daily; for GERD and maintenance of healing of erosive esophagitis

Elderly

Standard adult dosing; no routine dose adjustment required, but use the lowest effective dose for the shortest duration necessary

Kidney Impairment

No adjustment needed

Liver Impairment

Severe hepatic impairment: consider dose reduction; do not exceed 20 mg once daily.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Can be stopped when no longer indicated; after prolonged/high-dose therapy, consider step-down or taper to reduce rebound acid hypersecretion.

Overdose

Overdose usually causes non-specific symptoms (e.g., nausea/vomiting, abdominal pain, dizziness, drowsiness, headache, tachycardia/confusion); management is supportive/symptomatic, and hemodialysis is not expected to be effective.

Patient Counseling

Take EPIRAZOLE (omeprazole) 20 mg on an empty stomach 30-60 minutes before a meal (preferably breakfast). Swallow the capsule whole; do not crush/chew. If you cannot swallow it, you may open the capsule and swallow the pellets with a small amount of soft acidic food (e.g., applesauce) without chewing. Use for the prescribed duration; tell your clinician if you develop persistent diarrhea, rash, or symptoms of low magnesium (cramps, palpitations). Inform your clinician/pharmacist about all medicines-especially clopidogrel, warfarin, methotrexate, tacrolimus, and HIV medicines (rilpivirine/nelfinavir should not be used with omeprazole).

Monitoring Requirements

With prolonged therapy: consider monitoring magnesium (especially if on diuretics/digoxin) and assess for vitamin B12 deficiency risk; monitor INR more closely if co-administered with warfarin; consider bone health/fracture risk in long-term/high-dose use.

Pharmacology

Mechanism of Action

Proton pump inhibitor that irreversibly inhibits the gastric parietal cell H+/K+-ATPase, blocking the final step of gastric acid secretion.

Onset of Action

Symptom/acid reduction begins within about 1 hour of a dose, but maximal acid suppression typically requires 3-4 days of daily dosing.

Duration of Effect

Approximately 24 hours of acid suppression per dose, with maximal effect reached after ~3-4 days of daily dosing.

Half-Life

Approximately 0.5-1 hour (about 1 hour)

Bioavailability

Approximately 30-40% after a single oral dose; increases to about 60-65% with repeated once-daily dosing

Metabolism

Extensive hepatic metabolism mainly via CYP2C19 and CYP3A4

Excretion

Approximately 77% renal excretion (as metabolites), 20% fecal

Protein Binding

Approximately 95% protein bound

Product Information

Available Dosage Forms

For this product specifically: oral enteric-coated (delayed-release) capsule containing enteric-coated pellets, 20 mg (blister pack).

Composition per Dose

Each enteric-coated pellet capsule: 20mg omeprazole

Generic Availability

Yes

OTC Alternatives

OTC alternatives (where locally available) include antacids (e.g., aluminum/magnesium hydroxide, calcium carbonate), H2-receptor antagonists (e.g., famotidine), and OTC PPIs (e.g., omeprazole 20 mg, esomeprazole 20 mg, lansoprazole 15 mg, pantoprazole 20 mg).

Gi Condition

Acid Reflux/GERD, Ulcer

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