GASEC 20/MG CAP 28/CAP

Indications

Approved Uses

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

Off-Label Uses

Common off-label uses include stress ulcer prophylaxis in critically ill patients (often institution/protocol-driven), laryngopharyngeal reflux, and functional dyspepsia; eosinophilic esophagitis is also used (PPI-responsive EoE) as part of management depending on guideline framework.

Dosage & Administration

Dosing by Condition

Adults (typical guideline/label-based regimens): 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 2-4 weeks (commonly 4 weeks). Gastric ulcer: 20 mg once daily for 4-8 weeks (often 8 weeks). H. pylori eradication: 20 mg twice daily as part of combination therapy for 10-14 days (regimen-dependent). NSAID-associated ulcer treatment: 20 mg once daily for 4-8 weeks; prevention in at-risk patients: 20 mg once daily. Zollinger-Ellison syndrome: start 60 mg once daily and titrate; divide doses when high (e.g., >80 mg/day).

Initial Dose

20mg once daily.

Maintenance Dose

10-20mg once daily.

Maximum Dose

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

Children's Dosage

Children 1-2 years (body weight ≥10kg): 10mg once daily; Children 2-16 years (body weight 10-20kg): 10mg once daily; Children 2-16 years (body weight >20kg): 20mg once daily; Adolescents ≥16 years: adult dosing

Dose Adjustment Notes

Renal impairment: no dose adjustment. Hepatic impairment: consider dose reduction; in severe hepatic impairment, a maximum of 20 mg/day is commonly recommended. For Zollinger-Ellison syndrome, high total daily doses (e.g., >80 mg/day) should be divided.

How to Take

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

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key warnings/precautions: may mask gastric malignancy-evaluate alarm symptoms and consider malignancy before/if symptoms persist; increased risk of C. difficile and other enteric infections; hypomagnesemia with prolonged use (monitor in long-term therapy and with digoxin/diuretics); fracture risk with long-term/high-dose therapy; possible vitamin B12 deficiency with long-term use; consider acute interstitial nephritis if renal symptoms; lupus erythematosus (SCLE/SLE)-discontinue if suspected; consider CYP2C19 poor metabolizers may have higher exposure.

Age Restriction

Not recommended for routine use in infants <1 year unless prescribed by a specialist/physician for a clear indication (off-label in many settings).

Drug Interactions

Drug Interactions

Clinically important interactions include: clopidogrel (reduced activation/antiplatelet effect via CYP2C19 inhibition), high-dose methotrexate (delayed clearance/increased toxicity risk), warfarin (↑INR/bleeding risk-monitor), phenytoin and diazepam (↑levels via CYP2C19 inhibition-monitor), digoxin (↑absorption; risk higher with hypomagnesemia), tacrolimus (↑levels-monitor), atazanavir/nelfinavir and rilpivirine (reduced antiviral exposure/contraindicated or avoid), azole antifungals such as ketoconazole/itraconazole (reduced absorption), and St. John’s wort (↓omeprazole exposure).

Interaction Severity

CONTRAINDICATED/AVOID: nelfinavir; rilpivirine (clinically significant reduction in antiretroviral exposure with acid suppression). AVOID/NOT RECOMMENDED: atazanavir (reduced absorption/exposure). MAJOR/CLINICALLY SIGNIFICANT: clopidogrel (reduced activation via CYP2C19-avoid or use alternative PPI when possible); high-dose methotrexate (may increase levels/toxicity-consider temporary PPI interruption/monitor). MODERATE (monitor/adjust): warfarin (INR), phenytoin and diazepam (CYP2C19 inhibition may increase levels), tacrolimus (levels), digoxin (increased absorption esp. with hypomagnesemia), azole antifungals such as ketoconazole/itraconazole (reduced absorption).

Food Interaction

Food can reduce/delay absorption; take on an empty stomach 30-60 minutes before a meal for optimal effect.

Special Populations

Pregnancy

Consult Doctor

Children

Children 1-2 years (body weight ≥10kg): 10mg once daily; Children 2-16 years (body weight 10-20kg): 10mg once daily; Children 2-16 years (body weight >20kg): 20mg once daily; Adolescents ≥16 years: adult dosing

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 a maximum of 20 mg/day; mild-moderate impairment: usually no adjustment needed.

Storage & Patient Advice

Stopping the Medicine

If used long-term, do not stop abruptly without a plan; consider tapering/step-down to reduce rebound acid hypersecretion, and consult the prescriber if symptoms recur.

Patient Counseling

Take 30-60 minutes before a meal (preferably breakfast) and swallow the capsule whole (do not crush/chew). It may take 2-4 days for full benefit. Use for the prescribed duration only; tell your clinician about all medicines (notably clopidogrel, warfarin, tacrolimus, digoxin, antiretrovirals). Seek care for severe/persistent diarrhea, signs of low magnesium (muscle cramps/spasms, palpitations), or allergic rash; long-term use may be associated with low magnesium/B12 and increased fracture risk in susceptible patients.

Monitoring Requirements

Short-term: no routine labs. Long-term or high-risk: monitor serum magnesium (especially if also on diuretics or digoxin), consider vitamin B12 with prolonged therapy, and monitor INR if co-administered with warfarin; assess for fracture risk and C. difficile-associated diarrhea if clinically indicated.

Pharmacology

Mechanism of Action

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

Onset of Action

Initial acid suppression begins within ~1 hour of a dose, but maximal effect typically requires 2-4 days of once-daily dosing.

Duration of Effect

Acid suppression lasts about 24 hours per dose; antisecretory effect may persist for ~2-3 days after stopping due to irreversible proton pump inhibition and time needed for new pump synthesis.

Half-Life

Approximately 0.5-1 hour (about 1 hour) for plasma elimination half-life

Bioavailability

Oral bioavailability is ~30-40% after a single dose and increases to ~60% with repeated dosing.

Metabolism

Hepatic metabolism mainly via CYP2C19 and CYP3A4 to inactive metabolites (e.g., hydroxy-omeprazole and omeprazole sulfone)

Protein Binding

Approximately 95% (often reported as ~95% or 95-97%)

Product Information

Available Dosage Forms

For this PRODUCT per verified API data: gastro-resistant capsule, hard (oral). (Omeprazole in general is also available in gastro-resistant tablets and powder/granules for oral suspension; IV omeprazole exists in some markets but is not a dosage form of this specific registered product.)

Composition per Dose

Each gastro-resistant capsule: 20mg omeprazole

Generic Availability

Yes

OTC Alternatives

Given this product is SFDA prescription-only, OTC alternatives for mild symptoms include antacids (e.g., aluminum/magnesium hydroxide, calcium carbonate) and H2-receptor antagonists (e.g., famotidine). (OTC omeprazole availability is jurisdiction-specific and should not be assumed.)

Gi Condition

Acid Reflux/GERD, Ulcer

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.