Esomeprazole
Visa No.: 893110041500
Product: Esomeprazole 40mg
API: Esomeprazol
Product Category: Gastrointestinal
Version approved leaflet: 41/QĐ-QLD_06/02/2017_157
INDICATIONS
- Used in combination with an appropriate antibacterial regimen for the eradication of Helicobacter pylori, healing of H. pylori–associated duodenal ulcers, and prevention of ulcer recurrence in patients with H. pylori infection.
- Gastroesophageal reflux disease (GERD).
- Prevention and treatment of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs).
- Zollinger–Ellison syndrome.
DOSAGE AND ADMINISTRATION
Take at least 1 hour before meals. Swallow capsules whole with water; do not crush, open, or chew
Dosage should follow medical advice; available strengths include ESOIXIUM 20 mg or 40 mg.
Adults and adolescents ≥ 12 years
Gastroesophageal reflux disease (GERD)
- Treatment of reflux esophagitis: 20–40 mg once daily for 4–8 weeks; may extend an additional 4–8 weeks if symptoms persist or if esophagitis is confirmed endoscopically. Maintenance of healed esophagitis: 20 mg once daily, duration up to 6 months.
- Symptomatic GERD without esophagitis: 20 mg once daily for 4 weeks; may continue for another 4 weeks if symptoms persist.
Eradication of Helicobacter pylori
As part of triple therapy with amoxicillin and clarithromycin: 20 mg twice daily for 7 days, or 40 mg once daily, according to the prescribed regimen.
NSAID-associated ulcers
- Prevention in high-risk patients requiring continued NSAID therapy: 20 mg once daily.
- Treatment of gastric ulcers due to NSAIDs: 20 mg once daily for 4–8 weeks.
Zollinger–Ellison syndrome
The recommended initial dose is 40 mg once daily. Thereafter, the dose should be adjusted according to the inpidual patient’s response, and treatment should be continued for as long as clinically indicated.
Clinical data indicate that most patients are adequately controlled with esomeprazole doses ranging from 80 to 160 mg per day. When the daily dose exceeds 80 mg, the total daily dose should be pided into two doses. Special populations
Children < 12 years: Not recommended (insufficient data).
Renal impairment / elderly: No dose adjustment required.
Hepatic impairment:
Mild to moderate: No dose adjustment.
Severe: Do not exceed 20 mg/day
CONTRAINDICATIONS
Hypersensitivity to esomeprazole, substituted benzimidazoles, or any excipient of the product.
WARNINGS AND PRECAUTIONS
This medicine should be used only under medical supervision.
Carefully read the instructions before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.
