ESOPOLE 20/MG CAP 28/CAP

Indications

Approved Uses

GERD (symptomatic reflux) and erosive esophagitis (healing and maintenance of healed erosive esophagitis); pathological hypersecretory conditions including Zollinger-Ellison syndrome; H. pylori eradication as part of combination therapy to reduce duodenal ulcer recurrence; risk reduction/prevention of NSAID‑associated gastric ulcer in at‑risk patients.

Off-Label Uses

Common off-label uses include laryngopharyngeal reflux (LPR), stress ulcer prophylaxis in critically ill patients (institution/protocol dependent), and as part of therapy for eosinophilic esophagitis (PPI-responsive EoE).

Side Effects

Common Side Effects

Headache, nausea, diarrhea, abdominal pain, flatulence, constipation, dry mouth, dizziness

Side Effect Frequency

Common (1-10%): headache, abdominal pain, diarrhea, nausea/vomiting, flatulence, constipation. Uncommon (0.1-1%): dizziness, dry mouth, dermatitis, pruritus, urticaria. Rare/very rare (<0.1%): hypersensitivity reactions, interstitial nephritis, severe cutaneous adverse reactions (e.g., SJS/TEN), hepatitis/liver enzyme elevations; hypomagnesemia is typically reported as rare and usually with long-term use.

Safety & Warnings

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions include: clopidogrel (reduced activation/antiplatelet effect), warfarin (↑INR/bleeding risk), high-dose methotrexate (↑levels/toxicity), digoxin (↑absorption), drugs needing acidic pH (e.g., ketoconazole/itraconazole, iron salts) (↓absorption), antiretrovirals (contraindicated with nelfinavir and rilpivirine; avoid/monitor with atazanavir), tacrolimus (↑levels), CYP inducers (rifampin, St. John’s wort) (↓esomeprazole exposure), and CYP2C19 substrates such as diazepam/citalopram (↑exposure in some patients).

Alcohol Interaction

Safe

Special Populations

Breastfeeding

Caution

Elderly

Standard adult dosing; no routine dose adjustment required

Kidney Impairment

No adjustment needed.

Liver Impairment

Mild-to-moderate impairment: no adjustment needed. Severe impairment (Child-Pugh Class C): do not exceed 20 mg/day.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule. Do not double doses.

Overdose

Symptoms are usually non-specific (e.g., confusion, drowsiness, blurred vision, tachycardia, nausea/vomiting, headache); management is supportive/symptomatic, and hemodialysis is unlikely to be useful.

Pharmacology

Half-Life

Approximately 1-1.5 hours (plasma elimination half-life) after oral dosing

Bioavailability

Systemic exposure comparable to enteric-coated formulation; bioavailability data not specified for 20 mg modified-release

Metabolism

Hepatic metabolism primarily via CYP2C19 and secondarily via CYP3A4

Product Information

Available Dosage Forms

Modified-release capsule, delayed-release tablet, powder for oral suspension, intravenous injection

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD

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