ACILOC 40/MG CAP 14/CAP

Indications

Approved Uses

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

Off-Label Uses

["Stress ulcer prophylaxis in critically ill patients (often institutional protocol-driven; IV/enteral depending on setting)", "Laryngopharyngeal reflux (selected patients)", "Functional dyspepsia (selected patients)"]

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; 40 mg once daily may be used for severe disease or inadequate response.
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 for 10-14 days with appropriate antibiotics (per local regimen).
Zollinger-Ellison syndrome: Start 60 mg once daily; titrate to clinical response; doses >80 mg/day should be divided (up to ~120 mg/day or higher in selected cases).
NSAID-associated ulcer prophylaxis: 20 mg once daily while NSAID risk persists.

Initial Dose

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

Maintenance Dose

20mg once daily

Maximum Dose

For Zollinger-Ellison syndrome, doses may be titrated up to 360 mg/day in divided doses; for typical GERD/ulcer indications, usual maximum is 40 mg/day (occasionally 80 mg/day for specific regimens).

Children's Dosage

Children 1-16 years: 10-20mg once daily based on weight (10mg for 10-<20kg, 20mg for ≥20kg) for GERD/EE. Use and dose must be determined by doctor for other conditions. Not recommended under 1 year of age.

Dose Adjustment Notes

Renal impairment: no dose adjustment generally required. Hepatic impairment: consider dose reduction/maximum 20 mg daily in severe hepatic impairment (or use the lowest effective dose with monitoring).

How to Take

Take orally 30-60 minutes before a meal (preferably 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 food (e.g., applesauce/yogurt) or mixed with a slightly acidic liquid and swallowed immediately without chewing; do not store the mixture.

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, flatulence, constipation. Uncommon (0.1-1%): dizziness, insomnia, rash/pruritus/urticaria, elevated liver enzymes. Rare/very rare (<0.1%): acute interstitial nephritis, severe cutaneous adverse reactions (e.g., SJS/TEN), hypomagnesemia (typically with prolonged use), subacute cutaneous lupus erythematosus; fracture and vitamin B12 deficiency are recognized risks mainly with long-term therapy rather than typical short-course frequency reporting.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key precautions: evaluate alarm features/consider malignancy before treatment (PPIs may mask symptoms); risk of C. difficile diarrhea; long-term/high-dose use-fracture risk, hypomagnesemia (consider monitoring), and vitamin B12 deficiency; acute interstitial nephritis; cutaneous/systemic lupus; and potential false-negative chromogranin A testing (hold PPI before testing when feasible).

Age Restriction

Pediatric use is condition- and formulation-specific; omeprazole is used in infants and children (including <1 year) under specialist/prescriber direction, but this 40 mg gastro‑resistant capsule is generally intended for older children/adolescents/adults who can swallow capsules-no OTC age limit applies because this product is prescription-only.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: clopidogrel (reduced activation/antiplatelet effect), warfarin (↑INR/bleeding risk), phenytoin and diazepam (↑levels via CYP2C19 inhibition), high-dose methotrexate (↑levels/toxicity), digoxin (↑exposure), tacrolimus (↑levels), rilpivirine and nelfinavir (contraindicated), atazanavir (reduced levels/avoid), azole antifungals such as ketoconazole/itraconazole (reduced absorption), and strong CYP inducers such as rifampin and St. John’s wort (reduced omeprazole exposure).

Interaction Severity

"MAJOR/Contraindicated: ["Rilpivirine (contraindicated due to reduced absorption with increased gastric pH)
Nelfinavir (contraindicated due to reduced antiviral exposure)"], "MODERATE/Clinically significant (manage/monitor or consider alternatives): ["Clopidogrel (reduced activation via CYP2C19 inhibition; consider alternative PPI such as pantoprazole when clinically appropriate)
High-dose methotrexate (may increase methotrexate levels/toxicity; consider temporary PPI interruption and monitoring)
Warfarin (possible INR increase; monitor INR)
Tacrolimus (possible increased levels; monitor troughs)
Digoxin (possible increased exposure; monitor especially in elderly/renal impairment)
Azole antifungals requiring acidity e.g., ketoconazole/itraconazole (reduced absorption; avoid or manage)
Phenytoin (possible increased levels; monitor)"], "MINOR/Long-term considerations: ["Iron salts (reduced absorption in some patients)
Vitamin B12 (reduced absorption with prolonged therapy)"]

Food Interaction

Take on an empty stomach, ideally 30-60 minutes before a meal.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Children 1-16 years: 10-20mg once daily based on weight (10mg for 10-<20kg, 20mg for ≥20kg) for GERD/EE. Use and dose must be determined by doctor for other conditions. Not recommended under 1 year of age.

Elderly

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

Kidney Impairment

No adjustment needed.

Liver Impairment

Severe hepatic impairment: consider dose reduction; usual maximum recommended is 20 mg/day (10-20 mg/day often sufficient). Mild-moderate impairment: generally no adjustment.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not double the dose.

Stopping the Medicine

Short courses can be stopped when the course is complete/symptoms resolve; after prolonged or high-dose therapy, consider tapering (or step-down) to reduce rebound acid hypersecretion.

Overdose

Symptoms can include confusion, drowsiness, blurred vision, tachycardia, nausea/vomiting, flushing/diaphoresis, headache (± dry mouth); management is supportive/symptomatic and omeprazole is not meaningfully removed by dialysis-seek urgent medical care/poison center advice.

Patient Counseling

Take 30-60 minutes before a meal (usually breakfast). Swallow the capsule whole; do not crush/chew; if needed, open and swallow granules mixed with a small amount of soft food/liquid without chewing. Symptom relief may start the first day but full effect can take 1-4 days. Seek care for severe/persistent diarrhea, rash/joint pain, or signs of low magnesium (cramps, palpitations) with prolonged use; discuss long-term risks (B12 deficiency, fractures) and important interactions (especially clopidogrel and certain HIV medicines such as rilpivirine/nelfinavir).

Monitoring Requirements

Short-term: no routine labs typically required. Long-term or high-dose therapy: consider serum magnesium (especially if >3 months or with diuretics), vitamin B12 if prolonged use/risk factors, and assess fracture risk/bone health in at-risk patients; monitor renal function if symptoms suggest acute interstitial nephritis; monitor for C. difficile-associated diarrhea if severe/persistent diarrhea occurs.

Pharmacology

Mechanism of Action

Omeprazole irreversibly inhibits the gastric parietal cell H+/K+-ATPase (proton pump), blocking the final step of acid secretion.

Onset of Action

Acid suppression begins within ~1 hour of a dose; maximal effect is not immediate and typically requires 1-4 days of daily dosing to reach steady-state acid suppression.

Duration of Effect

Up to 72 hours.

Half-Life

Plasma half-life ~0.5-1 hour; duration of acid suppression is ~24 hours due to irreversible proton pump inhibition.

Bioavailability

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

Metabolism

Extensive hepatic metabolism via CYP2C19 (primary) and CYP3A4 (secondary), with metabolites excreted mainly in urine.

Excretion

Eliminated mainly as metabolites in urine (~70-80%) with the remainder in feces (~20-30%).

Protein Binding

Approximately 95%.

Product Information

Available Dosage Forms

For this SFDA-registered product: gastro‑resistant capsule, hard (oral).

Composition per Dose

Each gastro-resistant hard capsule: 40mg omeprazole

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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