Composition Othera® 20 mg tablet: Each Biphasic Micro Pellets (MUPS) tablet contains Esomeprazole Magnesium Trihydrate enteric coated micro pellets equivalent to Esomeprazole USP 20 mg. Othera® 40 mg tablet: Each Biphasic Micro Pellets (MUPS) tablet contains Esomeprazole Magnesium Trihydrate enteric coated micro pellets equivalent to Esomeprazole USP 40 mg. Pharmacology Othera® is the preparation of Esomeprazole Magnesium Trihydrate which is an antisecretory compound that suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Indication Othera® is indicated to treat the following conditions: Adults (from the age of 18 years) • Gastroesophageal reflux disease (GERD) - Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) - Maintenance treatment of NERD (i.e. heartburn and regurgitation) - Reflux esophagitis or erosive esophagitis - Maintenance treatment of patients with reflux esophagitis • Healing of NSAID associated gastric ulcers • Reduction of risk of NSAID associated gastric ulcers • Zollinger-Ellison Syndrome • H. pylori eradication Pediatrics (12-17 years of age) • Gastroesophageal reflux disease (GERD) - Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) - Reflux esophagitis or erosive esophagitis Dose and administration Route of administration: Othera® is taken orally with or without food. Contraindication Esomeprazole is contraindicated in patient with known hypersensitivity to esomeprazole or any other components of this product. Warning and precaution Esomeprazole should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like esomeprazole may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year. Side effects The most common side effects of esomeprazole are nausea, vomiting, abdominal pain, flatulence, diarrhea, constipation and headache. Less frequent side effects include dry mouth, peripheral edema, dizziness, sleep disturbances, fatigue, paraesthesia, arthralgia, myalgia, rash and pruritus. Other side effects reported rarely or very rarely include taste disturbance, stomatitis, hepatitis, jaundice, hypersensitivity reactions (including anaphylaxis, bronchospasm), fever, depression, hallucinations, confusion, gynaecomastia, interstitial nephritis, hyponatraemia, blood disorders (including leucopenia, leukocytosis, pancytopenia, thrombocytopenia), visual disturbances, sweating, photosensitivity, alopecia, Stevens-Johnson Syndrome and toxic epidermal necrolysis. Use in pregnancy and lactation Pregnancy: For esomeprazole, limited clinical data on exposed pregnancies are available. Esomeprazole should only be given to pregnant women if its use is considered essential. Lactation: It is not known whether esomeprazole is excreted in breast milk. Therefore esomeprazole should not be used during breast-feeding. Drug interaction Drug interaction with medication: Esomeprazole is a CYP2C19 inhibitor. When starting or stopping treatment with esomeprazole should be taken into account potential interactions with medicines through CYP2C19 metabolized. Drug interaction with food and others: Not applicable. Overdose There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg esomeprazole were uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized. Storage Keep away from the reach of children. Store below 250C protected from light & moisture. To be taken and sold only on the prescription of a registered physician. Packing Othera® 20 mg tablet: Carton of 50 tablets in Alu-Alu blister pack. Othera® 40 mg tablet: Carton of 30 tablets in Alu-Alu blister pack. Indication Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) Maintenance treatment of NERD (i.e. heartburn and regurgitation) Maintenance therapy of healing of reflux esophagitis Healing of NSAID associated gastric ulcers Risk reduction of NSAID associated gastric ulcers H. pylori eradication (Othera® with amoxicillin 1000 mg and clarithromycin 500 mg) Zollinger-Ellison Syndrome Reflux esophagitis or erosive esophagitis Dose Frequency Adults (from the age of 18 years) 20 mg 20 mg 20 mg 20 mg 40 mg 20 mg 20 mg 40 mg Once daily Once daily Once daily Once daily for 2-4 weeks Once daily for 4-8 weeks Once daily for 4-8 weeks Twice daily Twice daily for 7 days Gastroesophageal reflux disease (GERD) Indication Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) Reflux esophagitis or erosive esophagitis Dose Frequency Pediatrics (12 to 17 years) 20 mg 20 mg or 40 mg Once daily for 4-8 weeks Once daily for 2-4 weeks Gastroesophageal reflux disease (GERD)