OMIZ 20/MG CAP 14/CAP

Indications

Approved Uses

Acid-related disorders including GERD (with/without erosive esophagitis), peptic ulcer disease (duodenal and gastric ulcers), Helicobacter pylori eradication as part of combination therapy, and pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome); also used for NSAID-associated ulcer treatment/prevention depending on local labeling.

Dosage & Administration

Dosing by Condition

Typical adult dosing: 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 (some patients may require 40 mg daily per severity/label). Duodenal ulcer: 20 mg once daily for 4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks. H. pylori eradication: 20 mg twice daily for 10-14 days with appropriate antibiotics (regimen-dependent). Zollinger-Ellison: start ~60 mg once daily and titrate; doses >80 mg/day should be divided.

Initial Dose

20mg once daily.

Maintenance Dose

20mg once daily

Maximum Dose

120mg per day (Zollinger-Ellison syndrome); 40mg per day for standard indications

Children's Dosage

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

How to Take

Take orally on an empty stomach, ideally 30-60 minutes before a meal (often 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/acidic food (e.g., applesauce) and swallowed immediately without chewing; do not store the mixture.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles, or any excipient; concomitant use with rilpivirine-containing products; concomitant use with nelfinavir

Warnings & Precautions

May mask gastric malignancy-evaluate alarm features; long-term use associated with hypomagnesemia, fractures, and vitamin B12 deficiency; risk of C. difficile diarrhea; acute interstitial nephritis; possible drug-induced lupus; consider interaction risk (e.g., clopidogrel/warfarin/phenytoin) and reassess ongoing need for chronic therapy.

Age Restriction

Pediatric use is condition- and formulation-specific; generally approved/used in children ≥1 year for GERD/erosive esophagitis, and in infants (≥1 month) only for limited indications under specialist direction-this 20 mg capsule is typically not suitable for infants.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: clopidogrel (reduced activation via CYP2C19 inhibition-avoid/consider alternative PPI), high-dose methotrexate (delayed clearance-consider holding PPI), warfarin (↑INR/bleeding-monitor), phenytoin/diazepam/cilostazol (↑levels via CYP2C19-monitor), digoxin (↑absorption-monitor), drugs needing acidic pH (e.g., ketoconazole/itraconazole/posaconazole, iron salts-reduced absorption), antiretrovirals with pH dependence/contraindications (rilpivirine contraindicated; atazanavir/nelfinavir reduced exposure), tacrolimus (↑levels-monitor), and strong CYP inducers (rifampin, St. John’s wort) may reduce omeprazole effect.

Interaction Severity

MAJOR/Contraindicated: rilpivirine; nelfinavir (and generally avoid with atazanavir due to reduced absorption/exposure). IMPORTANT/Clinically significant: clopidogrel (reduced activation via CYP2C19-avoid or consider alternative PPI if needed). MODERATE: warfarin (monitor INR), high-dose methotrexate (consider temporary PPI hold), tacrolimus (monitor levels), phenytoin (monitor levels), digoxin (monitor in high-risk), azole antifungals requiring acidity (reduced absorption).

Food Interaction

Take on an empty stomach, 30-60 minutes before a meal for best effect.

Special Populations

Pregnancy

Category C

Children

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

Elderly

Standard adult dosing; no routine dose adjustment required, but monitor for hypomagnesemia and bone fracture risk with long-term use

Kidney Impairment

No adjustment needed.

Liver Impairment

Mild-moderate hepatic impairment: usually no adjustment; severe hepatic impairment: use the lowest effective dose and generally do not exceed 20 mg/day.

Storage & Patient Advice

Stopping the Medicine

Safe to stop after short-term courses; after prolonged use, rebound acid hypersecretion can occur-consider step-down/taper and reassess indication with a clinician.

Patient Counseling

Take on an empty stomach 30-60 minutes before a meal; swallow capsule whole (or sprinkle granules on a small amount of soft food and swallow without chewing if needed). Seek care for persistent/severe diarrhea, rash, or signs of low magnesium; discuss long-term risks (fracture risk, B12 deficiency) if prolonged therapy. Tell your clinician about all medicines, especially clopidogrel, warfarin, tacrolimus, phenytoin, and certain HIV medicines (rilpivirine/nelfinavir/atazanavir).

Monitoring Requirements

Short-term: usually no routine labs. Long-term/prolonged therapy: consider magnesium (especially if >3 months or with diuretics), assess for vitamin B12 deficiency with prolonged use, consider bone/fracture risk in high-risk patients, and monitor INR if on warfarin; monitor for renal adverse effects (e.g., AIN) if symptomatic.

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 hour; maximal acid suppression after a single dose occurs within a few hours, but full therapeutic effect typically requires 1-4 days of daily dosing.

Duration of Effect

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

Half-Life

0.5-1.2 hours.

Bioavailability

Oral bioavailability is ~30-40% after a single dose and increases to ~60% with repeated dosing (range varies by individual and formulation).

Metabolism

Extensive hepatic metabolism primarily via CYP2C19, with contribution from CYP3A4.

Excretion

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

Protein Binding

Approximately 95%.

Product Information

Available Dosage Forms

For this product: oral capsule 20 mg (SFDA-verified). Omeprazole as an active ingredient is also available in other markets/forms (e.g., delayed-release tablets/capsules, powder for oral suspension, and IV injection), but those are not the dosage form of OMIZ 20MG CAP.

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

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

Gi Condition

Acid Reflux/GERD, Ulcer

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