ESOPOLE 40/MG CAP 28/CAP

Dosage & Administration

Dosing by Condition

GERD (symptomatic): 20 mg once daily for 4 weeks (may extend to 8 weeks if needed).
Erosive esophagitis (healing): 20-40 mg once daily for 4-8 weeks.
Erosive esophagitis (maintenance of healed): 20 mg once daily.
H. pylori eradication (triple therapy): Esomeprazole 20 mg twice daily with amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily for 10-14 days (per local resistance/guidelines).
NSAID-associated gastric ulcer risk reduction: 20-40 mg once daily for the duration of NSAID therapy (commonly up to 6 months in trials).
Zollinger-Ellison syndrome/pathological hypersecretion: 40 mg twice daily initially; titrate to clinical response (doses up to 240 mg/day have been used).

Initial Dose

40mg once daily for healing of erosive esophagitis.

Maintenance Dose

20mg once daily for maintenance of healed erosive esophagitis.

Maximum Dose

Standard indications: 40 mg once daily (depending on indication); Zollinger-Ellison syndrome: doses up to 240 mg/day have been used (individualized, often divided).

Dose Adjustment Notes

Severe hepatic impairment (Child‑Pugh C): do not exceed 20 mg/day. Mild-moderate hepatic impairment: no adjustment. Renal impairment: no dose adjustment.

How to Take

Take orally on an empty stomach, ideally 30-60 minutes before a meal (commonly before breakfast). Swallow the modified‑release 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 food (e.g., applesauce) or mixed with water and swallowed immediately without chewing; do not store the mixture.

Safety & Warnings

Contraindications

Hypersensitivity to esomeprazole/other substituted benzimidazoles (PPIs) or any excipients; concomitant use with rilpivirine-containing products is contraindicated; avoid/contraindicated with nelfinavir (and generally not recommended with atazanavir).

Warnings & Precautions

Key warnings/precautions: may mask gastric malignancy (evaluate alarm symptoms); risk of C. difficile diarrhea; hypomagnesemia with prolonged use (consider monitoring, especially with diuretics/digoxin); fracture risk with long-term/high-dose use; possible vitamin B12 deficiency with long-term use; acute interstitial nephritis; and interference with chromogranin A testing (stop ~14 days before testing when feasible).

Drug Interactions

Interaction Severity

"Contraindicated/Avoid: ["Rilpivirine-containing products (marked reduction in absorption with acid suppression)
Nelfinavir (reduced antiviral exposure)"], "Major/Clinically significant (avoid or manage closely): ["Clopidogrel (reduced activation via CYP2C19 inhibition; consider alternative PPI or antiplatelet strategy)
Atazanavir (and other pH-dependent antiretrovirals; reduced absorption-generally avoid)"], "Moderate (monitor/adjust as needed): ["Warfarin (monitor INR)
High-dose methotrexate (consider temporary PPI interruption; monitor toxicity)
Tacrolimus (monitor levels)
Digoxin (monitor levels, especially with hypomagnesemia risk)
Ketoconazole/itraconazole/posaconazole suspension (reduced absorption due to higher gastric pH)"], "Minor: ["St. John’s wort/rifampin (may reduce PPI exposure via enzyme induction)"]

Special Populations

Pregnancy

Category C

Storage & Patient Advice

Stopping the Medicine

For long-term therapy, consider tapering or step-down rather than abrupt cessation to reduce rebound acid symptoms; consult prescriber if symptoms recur.

Patient Counseling

Take on an empty stomach 30-60 minutes before a meal; swallow the capsule whole (do not crush/chew). If you cannot swallow it, you may open the capsule and swallow the granules mixed with a small amount of applesauce or water immediately without chewing. Tell your clinician if you develop severe/persistent diarrhea, signs of low magnesium (cramps, palpitations, seizures), or kidney issues (reduced urination, swelling). With long-term use, discuss risks such as low magnesium, vitamin B12 deficiency, and fractures; review all medicines for interactions (notably clopidogrel and certain HIV medicines).

Monitoring Requirements

Long-term therapy: consider magnesium (especially if >3 months or with diuretics/digoxin), vitamin B12 with prolonged use, and assess for fracture risk in high-risk patients; monitor INR if on warfarin; evaluate renal function if symptoms suggest acute interstitial nephritis; monitor for persistent diarrhea/C. difficile risk when clinically indicated.

Pharmacology

Mechanism of Action

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

Onset of Action

Within 1 hour for acid suppression; symptom relief may begin within hours. Maximal effect after 3-4 days of once-daily dosing.

Duration of Effect

Approximately 24 hours per dose (once-daily acid suppression).

Half-Life

1-1.5 hours.

Metabolism

Hepatic metabolism mainly via CYP2C19 and to a lesser extent via CYP3A4 to inactive metabolites

Excretion

Primarily renal excretion of metabolites (~80%) and fecal excretion (~20%); negligible unchanged drug in urine

Protein Binding

Approximately 97% plasma protein binding

Product Information

Composition per Dose

Each modified-release capsule: 40mg esomeprazole (as esomeprazole magnesium trihydrate)

OTC Alternatives

OTC options (country-dependent) include antacids (e.g., calcium carbonate), H2-receptor antagonists (e.g., famotidine), and OTC PPIs such as omeprazole 20 mg or esomeprazole 20 mg where available; note ESOPOLE 40 mg is SFDA prescription-only.

Gi Condition

Acid Reflux/GERD

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