GASEC 40/MG 14/CAP

Indications

Approved Uses

Treatment of duodenal ulcers, treatment of gastric ulcers, treatment of gastroesophageal reflux disease (GERD), treatment of erosive esophagitis, eradication of Helicobacter pylori in combination with antibiotics, treatment of Zollinger-Ellison syndrome, prevention of NSAID-associated gastric and duodenal ulcers in patients at risk.

Dosage & Administration

Dosing by Condition

GERD (symptomatic): 20 mg once daily for 2-4 weeks; may continue up to 4-8 weeks if needed.
Erosive esophagitis: 20 mg once daily for 4-8 weeks (some patients may require 40 mg once daily).
Duodenal ulcer: 20 mg once daily for 4 weeks (may extend to 8 weeks if not healed).
Gastric ulcer: 20-40 mg once daily for 4-8 weeks.
H. pylori eradication: 20 mg twice daily with appropriate antibiotics for 10-14 days (regimen-dependent).
NSAID-associated ulcer (treatment): 20 mg once daily for 4-8 weeks; (prevention in at-risk patients often 20 mg once daily).
Zollinger-Ellison syndrome: Initial 60 mg once daily; titrate to clinical response; may require up to 120 mg/day, and doses >80 mg/day should be given in divided doses.

Initial Dose

20mg once daily for GERD or duodenal ulcer; 40mg once daily for gastric ulcer.

Maintenance Dose

20mg once daily

Maximum Dose

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

Children's Dosage

Children 1-16 years: 10-20mg once daily based on weight (10 to <20kg: 10mg; ≥20kg: 20mg). Not recommended under 2 years for some indications per label; use and dose determined by doctor.

How to Take

Oral: take once daily on an empty stomach, ideally 30-60 minutes before a meal (often before breakfast). Swallow the gastro‑resistant capsule whole with water; do not crush or chew. If swallowing is difficult, the capsule may be opened and the enteric-coated granules sprinkled on a small amount of soft/acidic food (e.g., applesauce/yogurt) or mixed with slightly acidic liquid and swallowed immediately without chewing (follow local product leaflet if it restricts this).

Side Effects

Common Side Effects

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

Safety & Warnings

Age Restriction

Approved for children ≥1 month for certain indications (e.g., GERD); dose based on weight and determined by doctor; use in children requires physician determination.

Drug Interactions

Drug Interactions

Key interactions include: clopidogrel (reduced activation), warfarin (↑INR), phenytoin/diazepam (↑levels via CYP2C19), high-dose methotrexate (↑levels/toxicity), digoxin (↑exposure), tacrolimus (↑levels), pH-dependent drugs (e.g., ketoconazole/itraconazole/atazanavir-reduced absorption), and strong CYP inducers (rifampin, St. John’s wort-reduced omeprazole effect); nelfinavir/rilpivirine are contraindicated.

Food Interaction

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

Special Populations

Children

Children 1-16 years: 10-20mg once daily based on weight (10 to <20kg: 10mg; ≥20kg: 20mg). Not recommended under 2 years for some indications per label; use and dose determined by doctor.

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; commonly do not exceed 20 mg/day (or use 10-20 mg/day).

Storage & Patient Advice

Patient Counseling

Take on an empty stomach 30-60 minutes before a meal (usually breakfast). Swallow the capsule whole with water; do not crush/chew. If you cannot swallow it, you may open the capsule and swallow the granules mixed with a small amount of soft/acidic food or liquid without chewing (per leaflet). Relief may start the first day, but best effect can take 3-4 days. Seek care for severe/persistent diarrhea, rash/swelling or breathing difficulty, or symptoms of low magnesium (muscle cramps, palpitations, seizures). Tell your clinician about warfarin, clopidogrel, digoxin, phenytoin, tacrolimus, or HIV medicines (rilpivirine/nelfinavir).

Pharmacology

Half-Life

About 0.5-1 hour (plasma half-life), with a longer duration of acid suppression due to irreversible pump inhibition.

Bioavailability

Approximately 30-40% after a single dose, increasing to ~60% with repeated dosing.

Metabolism

Extensive hepatic metabolism primarily via CYP2C19 and CYP3A4.

Product Information

Available Dosage Forms

For this SFDA-registered product: gastro‑resistant capsule, hard (40 mg) for oral use. (Omeprazole in general is also available in some markets as gastro‑resistant tablets/capsules, oral suspension/granules, and IV formulations, but those are not this specific product.)

Composition per Dose

Each gastro-resistant hard capsule: 40mg omeprazole

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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