Nexicure 20
Esomeprazole, Esomeprazole Magnesium Trihydrate USP • DAR No.: 431-005-067
Nexicure 20
Esomeprazole, Esomeprazole Magnesium Trihydrate USP
Anti-ulcerant, Gastrointestinal / Anti-flatulent / Digestive Aid (Proton Pump Inhibitor (PPI))
Esomeprazole, the S-isomer of Omeprazole, reduces gastric acid secretion through specific inhibition of the acid pump in the parietal cell, where it is concentrated and converted to the active form in the acid environment of the secretary canaliculi and inhibits the enzyme H+K+ATPase -the acid pump.
Quality Assured Medications (WHO-GMP Compliant)
Pharmacist Consultation & Medical Support
Product Specifications
Detailed clinical and therapeutic information for healthcare professionals.
Description
Esomeprazole, the S-isomer of Omeprazole, reduces gastric acid secretion through specific inhibition of the acid pump in the parietal cell, where it is concentrated and converted to the active form in the acid environment of the secretary canaliculi and inhibits the enzyme H+K+ATPase -the acid pump.
Composition & Active Ingredients
Each capsule contains Esomeprazole 20mg as Esomeprazole Magnesium Trihydrate USP in enteric coated pellets.
Indications & Therapeutic Uses
The FDA approved Esomeprazole for maintenance of healing of erosive esophagitis and in combination with Amoxicillin and Clarithromycin, for the eradication of Helicobacter pylori infection in patients with duodenal ulcer disease. The FDA approved Esomeprazole for risk reduction of NSAID induced stomach ulcer. Esomeprazole capsules are indicated for: • Treatment of Gastroesophageal Reflux Disease (GERD) • Healing of Erosive Esophagitis • Maintenance of Healing of Erosive Esophagitis • Symptomatic Gastroesophageal Reflux Disease (GERD) • Risk reduction of NSAID-associated gastric ulcer • H. pylori eradication to reduce the risk of duodenal ulcer disease and recurrence in combination with Amoxicillin and Clarithromycin • Pathological hypersecretory conditions (including Zollinger Ellison Syndrome)
Dosage & Administration
The capsule should be swallowed whole with liquid. The capsule should not be chewed or crushed and should be taken one hour before meal. Gastroesophageal Reflux Disease (GERD): 1. Healing of Erosive Esophagitis - 20mg or 40mg - Once daily for 4 to 8 weeks* 2. Maintenance of Healing of Erosive Esophagitis - 20mg - Once Daily** 3. Symptomatic Gastroesophageal Reflux - 20mg - Once daily for 4 weeks*** 4. Risk reduction of NSAID associated gastric ulcer - 20mg or 40mg - Once Daily for up to 6 Months** Triple Therapy for H. pylori Eradication: 1. Esomeprazole - 20 mg or 40 mg - Twice daily for 7 days or Once daily for 10 days 2. Amoxycillin - 1000mg - Twice daily for 7/10 days 3. Clarithromycin - 500mg - Twice daily for 7/10 days
Drug Interaction
Absorption of Ketoconazole and Itraconazole may decrease during treatment with Esomeprazole. Plasma concentrations of Diazepam, Citalopram, Imipramine, Clomipramine, Phenytoin etc. may be increased, requiring potential dose adjustment.
Side Effects
More frequent: Headache, abdominal pain, diarrhea, flatulence, nausea & vomiting. Less frequent: Dermatitis, pruritus, urticaria, dizziness.
Contraindications
Known hypersensitivity to Esomeprazole or any other constituents of the formulation.
Storage Conditions
Store in a cool (below 25°C) and dry place, protected from light & moisture.
Precaution & Caution
Symptomatic response does not preclude the presence of gastric malignancy. Acute interstitial nephritis has been observed in patients taking PPIs. Cyanocobalamin (vitamin B12) deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
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