ACILOC 20MG 14CAP

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

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 (some patients may require 40 mg once daily per severity/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 guideline regimen).
Zollinger-Ellison/hypersecretory states: Start 60 mg once daily; titrate to control; divide doses if >80 mg/day.
NSAID-associated ulcer prevention (high-risk): 20 mg once daily while NSAID continues (duration per risk/clinical plan).

Initial Dose

20mg once daily.

Maintenance Dose

10-20mg once daily

Maximum Dose

Doses up to 120mg three times daily have been used for pathological hypersecretory conditions like Zollinger-Ellison syndrome.

Children's Dosage

Children 1 month to <1 year: Dose based on body weight, usually 2.5-10 mg once daily; Children 1-16 years: 5-20 mg once daily based on weight (10-<20 kg: 10 mg; ≥20 kg: 20 mg); Not recommended under 1 month.

How to Take

Take orally on an empty stomach 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 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

Safety & Warnings

Age Restriction

Not recommended under 1 year of age

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: clopidogrel (reduced activation via CYP2C19 inhibition), high-dose methotrexate (delayed clearance/toxicity risk), warfarin (INR may increase-monitor), phenytoin and diazepam (levels may increase via CYP2C19 inhibition), digoxin (increased absorption), atazanavir/nelfinavir and rilpivirine (reduced antiviral exposure-avoid/contraindicated), tacrolimus (levels may increase-monitor), drugs needing acidic pH such as ketoconazole/itraconazole (reduced absorption), and CYP inducers like rifampin or St. John’s wort (reduced omeprazole exposure)

Food Interaction

Food can reduce/delay absorption; take on an empty stomach 30-60 minutes before a meal (preferably breakfast).

Special Populations

Children

Children 1 month to <1 year: Dose based on body weight, usually 2.5-10 mg once daily; Children 1-16 years: 5-20 mg once daily based on weight (10-<20 kg: 10 mg; ≥20 kg: 20 mg); Not recommended under 1 month.

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: do not exceed 20 mg/day; mild-moderate impairment: no routine adjustment

Storage & Patient Advice

Patient Counseling

Take on an empty stomach 30-60 minutes before breakfast; swallow the capsule whole (do not crush/chew; granules must not be chewed if capsule is opened). It may take several days (up to ~3-4 days) for full benefit. Seek medical advice for persistent/severe diarrhea, black stools/vomiting blood, or alarm symptoms (weight loss, dysphagia). With long-term use, discuss risks such as low magnesium/vitamin B12 and fracture risk; tell your clinician about interacting drugs (especially clopidogrel, warfarin, tacrolimus, certain antivirals).

Pharmacology

Onset of Action

Onset begins within ~1 hour after the first dose, but maximal acid suppression typically requires 3-4 days of continuous daily dosing.

Half-Life

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

Bioavailability

Approximately 30-40% after a single oral dose; increases to about 60-65% with repeated once-daily dosing

Metabolism

Hepatic via CYP2C19 (primary) and CYP3A4

Product Information

Available Dosage Forms

For this SFDA-registered product: gastro-resistant capsule, hard (oral), 20 mg (blister pack of 14).

Composition per Dose

Each gastro-resistant hard capsule: 20mg omeprazole

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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