Basic Information
SPRAZOLE-20 ESOMEPRAZOLE GASTRO RESISTANT 20 MG TABLETS
TABLET, DELAYED RELEASE
Regulatory Information
SIN16686P
February 8, 2023
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XA02BC05
Company Information
Active Ingredients
Strength: 20 MG
Detailed Information
Contraindications
**4.3 Contraindications** Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation.
Indication Information
**4.1 Therapeutic indications** Esomeprazole tablets are indicated for: **Gastroesophageal Reflux Disease (GERD)** - Treatment of erosive reflux esophagitis. - Long-term management of patients with healed esophagitis to prevent relapse. - Symptomatic treatment of gastroesophageal reflux disease (GERD). **In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and** - Healing of _Helicobacter pylori_ associated duodenal ulcer and - Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers. **Patients requiring continued NSAID therapy** - Healing of gastric ulcers associated with NSAID therapy. - Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric and/or duodenal ulcers. Controlled studies do not extend beyond 6 months. **Patients requiring continued low dose aspirin (75–325 mg) therapy** - Prevention of gastric and/or duodenal ulcers associated with low dose aspirin therapy, in patients at risk. **Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole IV solution by intravenous infusion.** **Treatment of Zollinger Ellison Syndrome**