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Brand : EMANERA

EMANERA 40/MG HARD CAP 28/CAP

61.7

Sku : I-031154
Key features
EMANERA 40mg Gastro-Resistant Capsule 28 Cap (brand EMANERA) is a prescription gastro-resistant capsule containing esomeprazole 40 mg. It suppresses gastric acid secretion by inhibiting the proton pump (H+/K+‑ATPase) in gastric parietal cells. It is indicated for healing and maintenance of GERD and erosive reflux esophagitis, as part of combination therapy for H. pylori eradication to reduce duodenal ulcer recurrence, prevention and treatment of NSAID‑associated gastric ulcers in at‑risk patients, and management of pathological hypersecretory conditions including Zollinger-Ellison syndrome. Supplied as gastro-resistant capsules in a pack of 28 capsules; prescription only.
- Brand: EMANERA
- Active Ingredient: ESOMEPRAZOLE 40mg
- Strength: 40mg
- Dosage Form: Gastro-resistant capsule
- Pack Size: 28 Capsules
- Route: Oral use
- Prescription Status: Prescription
- Therapeutic Class: Gastrointestinal
- Pharmacological Group: Proton Pump Inhibitors
- Drug Class: Proton Pump Inhibitor (PPI) - Benzimidazole derivative
- Manufacturer: KRKA dd Novo mesto
- Country of Origin: Slovenia
- SFDA Registration No.: 1410246039
- Shelf Life: 24 months
- Storage: store below 30°c
- Gi Condition: Acid Reflux/GERD, Ulcer

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Description

Specification

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

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.)