OMEPREX 20/MG 14/CAP

Indications

Approved Uses

Gastroesophageal reflux disease (GERD), duodenal ulcer, gastric ulcer, Helicobacter pylori eradication (in combination therapy), Zollinger-Ellison syndrome, erosive esophagitis, NSAID-associated gastric ulcer treatment and prevention

Off-Label Uses

Stress ulcer prophylaxis in critically ill patients (off-label in some settings depending on local protocols); other commonly used off-label indications include laryngopharyngeal reflux and functional dyspepsia.

Dosage & Administration

Dosing by Condition

Typical adult dosing (individualize per diagnosis/severity): GERD (symptomatic): 20 mg once daily for 4-8 weeks. Erosive esophagitis: 20 mg once daily (may use 40 mg once daily in more severe disease) for 4-8 weeks. Duodenal ulcer: 20 mg once daily for 4 weeks. Gastric ulcer: 40 mg once daily for 4-8 weeks (some patients may use 20 mg daily depending on regimen/response). H. pylori eradication: 20 mg twice daily with appropriate antibiotics for 10-14 days. Zollinger-Ellison syndrome: start 60 mg once daily and titrate; doses >80 mg/day should be divided.

Initial Dose

20mg once daily for GERD or duodenal ulcer.

Maintenance Dose

10-20mg once daily for maintenance of healed erosive esophagitis.

Maximum Dose

Doses up to 120mg daily have been used for hypersecretory conditions; doses above 80mg are typically divided.

Children's Dosage

Children 1-11 years (body weight 10-19 kg): 10 mg once daily; body weight ≥20 kg: 20 mg once daily. Children 12-17 years: 20-40 mg once daily. Not recommended under 1 year of age

Dose Adjustment Notes

Renal impairment: no dose adjustment required. Hepatic impairment: consider dose reduction/maximum 20 mg/day in severe hepatic impairment; use the lowest effective dose.

How to Take

Take orally 30-60 minutes before a meal (preferably before 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 granules sprinkled on a small amount of soft food (e.g., applesauce) and swallowed immediately without chewing; follow with water.

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/pruritus, elevated liver enzymes, peripheral edema; Rare/very rare: hypomagnesemia (typically with prolonged use), acute interstitial nephritis, severe cutaneous adverse reactions (e.g., SJS/TEN), subacute cutaneous lupus erythematosus

Safety & Warnings

Contraindications

Hypersensitivity to omeprazole/other PPIs (substituted benzimidazoles) or excipients; concomitant use with rilpivirine-containing products (contraindicated); concomitant use with nelfinavir (contraindicated).

Warnings & Precautions

Evaluate for alarm features/possible gastric malignancy if symptoms persist (PPIs can mask cancer); long-term use: consider risks of hypomagnesemia (monitor if prolonged use or with diuretics/digoxin), C. difficile diarrhea, fractures/osteoporosis, and vitamin B12 deficiency; be alert for acute interstitial nephritis; stop before chromogranin A testing to avoid false elevation; consider rare subacute cutaneous lupus.

Age Restriction

Prescription use: can be used in children ≥1 year for approved pediatric indications/weight-based dosing; not recommended in infants <1 year unless specialist-directed. OTC self-treatment (where applicable) is generally for adults (often ≥18 years) and is not applicable to this SFDA prescription product.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: clopidogrel (reduced activation via CYP2C19-avoid/consider alternative PPI), warfarin (↑INR-monitor), phenytoin/diazepam/citalopram (↑levels via CYP2C19-monitor), high-dose methotrexate (↑toxicity-consider holding PPI), digoxin (↑levels), tacrolimus (↑levels), atazanavir/nelfinavir/rilpivirine (reduced ARV exposure-nelfinavir & rilpivirine contraindicated; avoid atazanavir), azole antifungals/iron salts (reduced absorption), mycophenolate mofetil (possible reduced exposure), St. John’s Wort (may reduce PPI exposure via enzyme induction).

Interaction Severity

MAJOR/Contraindicated or avoid: rilpivirine (contraindicated with PPIs), nelfinavir (avoid/contraindicated), atazanavir (avoid or requires specialist management due to reduced exposure). MODERATE/Clinically significant: clopidogrel (reduced activation via CYP2C19 inhibition-avoid combination when possible or consider alternative PPI), warfarin (INR changes-monitor), high-dose methotrexate (may increase levels-consider temporary PPI hold), tacrolimus (may increase levels-monitor), digoxin (may increase exposure-monitor in high-risk), azole antifungals requiring acidity (e.g., ketoconazole/itraconazole-reduced absorption).

Food Interaction

Take on an empty stomach 30-60 minutes before a meal (preferably before breakfast).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Not assigned a pregnancy category. Use during pregnancy only if potential benefit justifies potential risk.

Breastfeeding

Caution

Children

Children 1-11 years (body weight 10-19 kg): 10 mg once daily; body weight ≥20 kg: 20 mg once daily. Children 12-17 years: 20-40 mg once daily. Not recommended under 1 year of age

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/day (often 10-20 mg/day). Mild-moderate impairment: usually no adjustment.

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

May stop without taper after short courses; for prolonged/chronic therapy, consider tapering or step-down (e.g., reduce dose/frequency or switch to H2RA/antacids) to minimize rebound acid hypersecretion and symptom recurrence, ideally with clinician guidance.

Overdose

Symptoms may include confusion, drowsiness, blurred vision, tachycardia, nausea/vomiting, flushing/diaphoresis, and headache; management is supportive/symptomatic, and hemodialysis is not expected to be useful-seek urgent medical care/poison center advice.

Patient Counseling

Take 30-60 minutes before a meal (preferably breakfast) and swallow the capsule whole (do not crush/chew). Full symptom control may take 1-4 days. Tell your prescriber about interacting drugs (especially clopidogrel, warfarin, tacrolimus, certain HIV meds such as rilpivirine/atazanavir/nelfinavir). Seek care for severe/persistent diarrhea, signs of low magnesium (cramps, palpitations, seizures), or allergic/renal symptoms; long-term use may be associated with low magnesium/B12 and increased fracture risk-use the lowest effective dose for the shortest duration prescribed.

Monitoring Requirements

Long-term therapy: consider monitoring magnesium (especially if also on diuretics/digoxin or if symptomatic) and assess for vitamin B12 deficiency with prolonged use; monitor INR if on warfarin; monitor tacrolimus levels if co-administered; monitor for C. difficile-associated diarrhea if significant diarrhea occurs.

Pharmacology

Mechanism of Action

Irreversibly inhibits the gastric parietal cell H+/K+-ATPase (proton pump), blocking the final step of gastric acid secretion.

Onset of Action

Onset within ~1-2 hours; maximal effect typically after 3-4 days of once-daily dosing.

Duration of Effect

Approximately 24 hours per dose (acid suppression persists beyond plasma half-life).

Half-Life

0.5-1 hour (plasma); antisecretory effect lasts ~24 hours due to irreversible proton pump inhibition

Bioavailability

Approximately 35-40% after single dose; increases to approximately 60% with repeated dosing

Metabolism

Extensive hepatic metabolism primarily via CYP2C19 and CYP3A4

Excretion

Primarily renal excretion of metabolites (~80% in urine) with the remainder in feces (~20%).

Protein Binding

Approximately 95%.

Product Information

Available Dosage Forms

For this SFDA-registered product (OMEPREX 20 mg): oral capsule only (blister pack of 14).

Composition per Dose

Each capsule: 20 mg omeprazole (as enteric-coated granules)

Generic Availability

Yes

OTC Alternatives

OTC alternatives for mild/intermittent symptoms include antacids (e.g., aluminum/magnesium hydroxide, calcium carbonate) and H2-receptor antagonists (e.g., famotidine).

Gi Condition

Acid Reflux/GERD, Ulcer

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