GASEC 20/MG CAP 14/CAP

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

GERD (symptomatic): 20 mg once daily for 2-4 weeks; may extend to 4-8 weeks if needed. Erosive esophagitis: 20 mg once daily for 4-8 weeks (some patients may require 40 mg daily depending on severity). Duodenal ulcer: 20 mg once daily for 4 weeks. Gastric ulcer: 20 mg once daily for 4-8 weeks (40 mg daily may be used in some regimens/severe disease). H. pylori eradication: 20 mg twice daily as part of combination therapy (commonly 10-14 days depending on regimen). NSAID-associated ulcer treatment: 20 mg once daily for 4-8 weeks; prevention: 20 mg once daily. Zollinger-Ellison syndrome: initial 60 mg once daily, titrate; doses >80 mg/day in divided doses (up to ~120 mg/day or higher per specialist).

Initial Dose

20mg once daily

Maintenance Dose

10-40mg once daily, depending on the condition.

Maximum Dose

Doses up to 120mg three times daily have been administered for pathological hypersecretory conditions.

Children's Dosage

Children 1 year of age and older-Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 20 mg once a day before a meal.

How to Take

Take orally 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 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) or mixed with a slightly acidic liquid, swallowed immediately without chewing, and followed with water.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key warnings/precautions: symptomatic response may mask gastric malignancy (evaluate alarm features); long‑term use associated with hypomagnesemia, B12 deficiency, fractures and fundic gland polyps; risk of C. difficile diarrhea; acute interstitial nephritis; lupus erythematosus (incl. SCLE); consider interaction risks (e.g., clopidogrel/warfarin/antiretrovirals) and use lowest effective dose for the shortest duration.

Age Restriction

Not routinely recommended in infants <1 year for this 20 mg gastro‑resistant capsule; pediatric use requires age/weight‑appropriate formulations and specialist direction.

Drug Interactions

Drug Interactions

Key interactions include: clopidogrel (reduced activation/antiplatelet effect), warfarin (↑INR/bleeding risk), phenytoin and diazepam (↑levels via CYP2C19 inhibition), tacrolimus (↑levels), high‑dose methotrexate (↑levels/toxicity), nelfinavir and rilpivirine (contraindicated), atazanavir (reduced absorption/exposure), rifampin and St. John’s wort (reduced omeprazole exposure), and drugs needing acidic pH for absorption such as ketoconazole/itraconazole (reduced absorption).

Interaction Severity

MAJOR/CONTRAINDICATED: nelfinavir (avoid with omeprazole); rilpivirine-containing products (avoid with PPIs); atazanavir (avoid or only with specialist-directed adjustments-generally not recommended with PPIs). MAJOR/CLINICALLY SIGNIFICANT: clopidogrel (avoid omeprazole/esomeprazole when possible; consider alternative PPI such as pantoprazole if PPI needed). MODERATE: warfarin (monitor INR), high-dose methotrexate (consider temporary PPI interruption/monitor toxicity), tacrolimus (monitor levels), digoxin (monitor especially with hypomagnesemia risk), azole antifungals requiring acidity (reduced absorption).

Food Interaction

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

Special Populations

Pregnancy

Category C

Children

Children 1 year of age and older-Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 20 mg once a day before a meal.

Kidney Impairment

No adjustment needed.

Liver Impairment

Severe hepatic impairment: consider dose reduction; maximum 20 mg once daily is commonly recommended. Mild-moderate impairment: usually no adjustment.

Storage & Patient Advice

Stopping the Medicine

Do not stop long‑term therapy abruptly without a plan; rebound acid hypersecretion can occur-taper or step‑down is reasonable for prolonged use.

Patient Counseling

Take 30-60 minutes before a meal (often breakfast) and 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/liquid without chewing. Full benefit may take 3-4 days. Seek care for severe/persistent diarrhea, signs of allergy/serious rash, or symptoms of low magnesium (muscle cramps, palpitations, seizures) with long-term use; tell your clinician about clopidogrel, warfarin, antiretrovirals (e.g., rilpivirine/atazanavir/nelfinavir), or high-dose methotrexate.

Monitoring Requirements

Long-term therapy: consider serum magnesium (especially if >3 months and/or with diuretics or digoxin), and consider vitamin B12 with prolonged use (e.g., >1 year) or risk factors; monitor for C. difficile-associated diarrhea if persistent diarrhea occurs; monitor renal function if signs of acute interstitial nephritis; if on warfarin, monitor INR when starting/stopping or changing dose.

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

Acid suppression begins within about 1 hour after a dose, but maximal effect typically requires ~3-4 days of once-daily dosing.

Duration of Effect

Up to 24 hours

Half-Life

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

Bioavailability

Approximately 35-40% after a single dose, increasing to about 60% with repeated dosing.

Metabolism

Extensive hepatic metabolism primarily via CYP2C19 and CYP3A4

Protein Binding

Approximately 95% (high protein binding, ~95%)

Product Information

Available Dosage Forms

For this PRODUCT (GASEC 20MG): gastro-resistant capsule, hard (oral). In general for omeprazole: delayed-release/gastro-resistant capsules or tablets, 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

OTC alternatives for mild/intermittent symptoms include antacids (e.g., aluminum/magnesium hydroxide, calcium carbonate) and H2-receptor antagonists (e.g., famotidine). Note: this specific product is prescription-only per verified API data.

Gi Condition

Acid Reflux/GERD, Ulcer

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