Enteric coated, oral, Tablet: 20 & 40 mg
Indication & usage:
Proton pump inhibitor
- Treatment of gastro esophageal reflux disease (GERD)
- Risk reduction of NSAID-associated gastric ulcer
- H. pylori eradication to reduce the risk of duodenal ulcer recurrence
- Pathological hyper secretory conditions, including Zollinger-Ellison syndrome
Dosage & Administration:
- Gastro esophageal Reflux Disease (GERD)
Adults: 20 mg or 40 mg once daily for 4 to 8 weeks
12 to 17 years: 20 mg or 40 mg once daily for up to 8 weeks
1 to 11 years: 10 mg or 20 mg once daily for up to 8 weeks
- 1 month to less than 1 year: 2.5 mg, 5 mg or 10 mg (based on weight). Once daily, up to 6 weeks for erosive esophagitis (EE) due to acid-mediated GERD only.
- Risk Reduction of NSAID-Associated Gastric Ulcer: 20 mg or 40 mg once daily for up to 6 months.
- pylori Eradication (Triple Therapy):
Esoflux 40 mg once daily for 10 days.
Amoxicillin 1000 mg twice daily for 10 days.
Clarithromycin 500 mg twice daily for 10 days.
Pathological Hyper Secretory Conditions: 40 mg twice daily
Most common adverse reactions:
- Adults (≥ 18 years) (incidence > 1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth
- Pediatric (1 to 17 years) (incidence > 2%) are headache, diarrhea, abdominal pain, nausea, and somnolence
- Pediatric (1 month to less than 1 year) (incidence 1%) are abdominal pain, regurgitation, tachypnea, and increased ALT
Esoflux is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticarial.
- May affect plasma levels of antiretroviral drugs
- Use with Atazanavir and Nelfinavir is not recommended; if Saquinavir is used with Esoflux monitor for toxicity and consider Saquinavir dose reduction.
- May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, Erlotinib, digoxin and Mycophenolate mofetil). Patients treated with Esoflux and digoxin may need to be monitored for digoxin toxicity.
- Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels.
- Clopidogrel: Esoflux decreases exposure to the active metabolite of Clopidogrel.
- May increase systemic exposure of Cilostazol and an active metabolite. Consider dose reduction.
- Tacrolimus: Esoflux may increase serum levels of tacrolimus
- Methotrexate: Esoflux may increase serum levels of methotrexate.
Warning & Precautions:
- Symptomatic response does not preclude the presence of gastric malignancy
- Atrophic gastritis has been noted with long-term omeprazole therapy
- Acute interstitial nephritis has been observed in patients taking PPIs.
- Cyanocobalamin (vitamin B-12) 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.
- Avoid concomitant use of Esoflux with Clopidogrel.
- Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
- Hypomagnesaemia has been reported rarely with prolonged treatment with PPIs.
- Avoid concomitant use of NEXIUM with St John’s Wort or rifampin due to the potential reduction in esomeprazole levels.
- Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
Pregnancy & Lactation:
Pregnancy Category C
Esomeprazole is likely present in human milk. Esomeprazole is the S-isomer of omeprazole and limited data indicate that maternal doses of omeprazole 20 mg daily produce low levels in human milk. Caution should be exercised when Esoflux is administered to a nursing woman.
Storage & Condition:
Store Esoflux below 25°C. Protect from light and moisture. Keep the container of Esoflux closed tightly. Keep out of reach of children.
Carton containing 1HDPE bottle of 28 tablets each.