EMANERA 40/MG HARD CAP 28/CAP

Indications

Approved Uses

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

Dosage & Administration

Children's Dosage

Children 1-11 years (body weight <20kg): 10mg once daily; (body weight ≥20kg): 10-20mg once daily. Adolescents 12-17 years: 20-40mg once daily. Not approved for children under 1 year

Safety & Warnings

Age Restriction

Not approved for routine use in infants <1 year for this 40 mg gastro‑resistant capsule; pediatric use is generally for ≥1 year (younger infants require age/weight-appropriate formulations and specific indications).

Drug Interactions

Drug Interactions

Clinically important interactions include: clopidogrel (reduced activation/antiplatelet effect), warfarin (INR changes-monitor), high-dose methotrexate (delayed clearance-consider holding PPI), digoxin (↑ exposure esp. with hypomagnesemia), tacrolimus (↑ levels), cilostazol (↑ exposure), diazepam (↓ clearance via CYP2C19), citalopram/escitalopram (↑ levels/QT risk-monitor), ketoconazole/itraconazole/iron salts (reduced absorption due to higher gastric pH), and antiretrovirals where acid suppression reduces exposure (atazanavir, nelfinavir, rilpivirine-avoid/contraindicated depending on product).

Food Interaction

Food can reduce/delay absorption; administer on an empty stomach, ideally 30-60 minutes before a meal (commonly before breakfast).

Special Populations

Children

Children 1-11 years (body weight <20kg): 10mg once daily; (body weight ≥20kg): 10-20mg once daily. Adolescents 12-17 years: 20-40mg once daily. Not approved for children under 1 year

Elderly

Standard adult dosing; no routine dose adjustment required

Kidney Impairment

No adjustment needed

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A/B): no adjustment; severe (Child-Pugh C): do not exceed 20 mg/day.

Pharmacology

Half-Life

1-1.5 hours.

Bioavailability

Oral bioavailability is ~50-64% after a single dose and increases to ~80-90% with repeated once-daily dosing.

Metabolism

Extensively hepatic metabolism via CYP2C19 (major) and CYP3A4 (minor) to inactive metabolites.

Product Information

Available Dosage Forms

For this SFDA-registered product: gastro‑resistant (delayed‑release) capsule for oral use. (Esomeprazole also exists in other markets as gastro‑resistant tablets, granules/powder for oral suspension, and IV injection/infusion, but those are separate products/registrations.)

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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