GASEC 40/MG 28/CAP

Indications

Approved Uses

GERD (including symptomatic GERD) and erosive esophagitis; gastric and duodenal ulcer; Helicobacter pylori eradication in combination with antibiotics; Zollinger-Ellison syndrome/other pathological hypersecretory conditions; treatment and prevention of NSAID-associated gastric/duodenal ulcers in at-risk patients.

Off-Label Uses

Common off-label uses include stress ulcer prophylaxis in critically ill patients (often via enteral route), laryngopharyngeal reflux, and eosinophilic esophagitis (as part of diagnostic/therapeutic trials).

Dosage & Administration

Dosing by Condition

Adults (typical): GERD/erosive esophagitis: 20-40 mg once daily for 4-8 weeks (maintenance often 20 mg daily). Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks. H. pylori eradication: 20 mg twice daily (or equivalent PPI dosing) for 10-14 days with appropriate antibiotics. NSAID-associated ulcer treatment: 20 mg once daily for ~4-8 weeks; prevention in high-risk patients: 20 mg once daily. Zollinger-Ellison: start 60 mg once daily, then titrate; doses >80 mg/day should be divided.

Initial Dose

20mg once daily for GERD or Duodenal Ulcer; 40mg once daily for Gastric Ulcer.

Maintenance Dose

20mg once daily

Maximum Dose

Doses up to 120mg daily have been used for Zollinger-Ellison syndrome; typically divided if over 80mg.

Children's Dosage

Children 2-16 years (≥10 kg): 10-20 mg once daily based on weight for GERD/EE. Not recommended under 2 years of age.

Dose Adjustment Notes

Renal impairment: no dose adjustment generally required. Hepatic impairment: consider dose reduction in severe hepatic impairment (often max 20 mg/day for usual indications); monitor clinical response. Hypersecretory states (e.g., Zollinger-Ellison): may require higher and/or divided doses per specialist titration.

How to Take

Oral: take once daily 30-60 minutes before a meal (preferably 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 sprinkled on a small amount of soft/acidic food (e.g., applesauce/yogurt) or mixed with slightly acidic liquid and swallowed immediately without chewing.

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, constipation, flatulence. Uncommon (0.1-1%): dizziness, insomnia, rash, pruritus, increased liver enzymes. Rare/very rare: severe cutaneous reactions (e.g., SJS/TEN), acute interstitial nephritis; hypomagnesemia is a rare/very rare long-term class effect.

Safety & Warnings

Contraindications

Hypersensitivity to omeprazole/other PPIs or excipients; concomitant use with nelfinavir is contraindicated; avoid/contraindicated with rilpivirine-containing products due to reduced absorption and virologic failure risk.

Warnings & Precautions

Precautions: evaluate for alarm features/possible gastric malignancy (symptom relief may mask cancer); long-term use may increase risk of fractures, hypomagnesemia, and vitamin B12 deficiency; risk of C. difficile diarrhea; acute interstitial nephritis; lupus (SCLE/SLE) reported; consider interaction risks (CYP2C19/pH effects) and monitor where appropriate.

Age Restriction

Pediatric use is condition- and formulation-dependent; omeprazole is used in infants ≥1 month for specific indications under specialist/physician direction, but this 40 mg gastro-resistant capsule is generally not appropriate for infants/young children due to dose/formulation (typically used in older children/adolescents/adults).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: clopidogrel (reduced activation via CYP2C19 inhibition-avoid/consider alternative PPI), warfarin (↑INR/bleeding-monitor), phenytoin/diazepam (↑levels-monitor), digoxin (↑levels esp. with hypomagnesemia-monitor), high-dose methotrexate (↑levels-consider temporary PPI hold), tacrolimus (↑levels-monitor), cilostazol (↑levels-consider dose adjustment), drugs needing acidic pH (e.g., ketoconazole/itraconazole-reduced absorption), antiretrovirals: nelfinavir (contraindicated), atazanavir (avoid/reduced exposure), rilpivirine (avoid/contraindicated), and enzyme inducers like rifampin/St. John’s wort (↓omeprazole exposure).

Food Interaction

Take on an empty stomach 30-60 minutes before a meal (preferably breakfast); food can delay absorption and reduce/slow onset of effect.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Category C

Breastfeeding

Safe

Children

Children 2-16 years (≥10 kg): 10-20 mg once daily based on weight for GERD/EE. Not recommended under 2 years of age.

Elderly

Standard adult dosing; no routine dose adjustment required, but monitor for hypomagnesemia and vitamin B12 deficiency with long-term use

Kidney Impairment

No adjustment needed

Liver Impairment

Severe hepatic impairment: consider dose reduction; 20 mg/day is often sufficient/maximum recommended in severe liver disease; mild-moderate impairment usually requires no adjustment.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not take two doses at the same time.

Stopping the Medicine

May be stopped when no longer indicated, but after prolonged/long-term use consider tapering or step-down/on-demand therapy to reduce rebound acid hypersecretion; consult prescriber if used long term.

Overdose

Symptoms can include nausea/vomiting, abdominal pain/diarrhea, headache, dizziness, flushing/diaphoresis, blurred vision, tachycardia, drowsiness/confusion; 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). Swallow capsule whole; do not crush/chew; if needed, open and swallow granules with a small amount of soft/acidic food without chewing. Use for the prescribed duration; report persistent/severe diarrhea, signs of low magnesium (cramps, palpitations, seizures), or rash. Tell your clinician about clopidogrel, warfarin, methotrexate, digoxin, phenytoin/diazepam, and any HIV medicines (rilpivirine/nelfinavir/atazanavir). Long-term use may be associated with low magnesium/B12 and increased fracture risk in susceptible patients.

Monitoring Requirements

Long-term therapy: consider monitoring magnesium (especially if >3 months or with diuretics), vitamin B12 with prolonged use/risk factors, and assess for C. difficile-associated diarrhea; consider bone fracture risk in high-risk patients. If co-administered with warfarin: monitor INR/prothrombin time after initiation/discontinuation or dose changes.

Pharmacology

Mechanism of Action

Proton pump inhibitor: irreversibly inhibits the gastric parietal cell H+/K+-ATPase, blocking the final step of acid secretion and reducing basal and stimulated gastric acid output.

Onset of Action

Onset: within ~1 hour; maximal acid suppression is achieved after several consecutive daily doses (typically 2-4 days).

Duration of Effect

Approximately 24 hours of acid suppression per dose (with greater effect after several days of daily dosing).

Half-Life

Approximately 0.5-1 hour (plasma elimination half-life).

Bioavailability

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

Metabolism

Extensively metabolized in the liver primarily by CYP2C19 and also by CYP3A4.

Product Information

Available Dosage Forms

For this SFDA-registered product: gastro-resistant capsule, hard (40 mg) for oral use (blister pack of 28).

Composition per Dose

Each gastro-resistant hard capsule: 40mg omeprazole

Generic Availability

Yes

OTC Alternatives

OTC options (country-dependent) include antacids (aluminum/magnesium hydroxide, calcium carbonate), H2-receptor antagonists (e.g., famotidine), and in some countries OTC omeprazole 20 mg for frequent heartburn.

Gi Condition

Acid Reflux/GERD, Ulcer

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