Prescribing Details
Description
No Data
Uses
No Data
Indications
Othera® is indicated to treat the following conditions:
Adults (from the age of 18 years)
Dosage and administration
Route of administration: Othera® is taken orally with or without food.
Adults (from the age of 18 years)
| Indication | Dose | Frequency |
|---|---|---|
| Gastroesophageal reflux disease (GERD) | ||
| Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) | 20 mg | Once daily for 2-4 weeks |
| Maintenance treatment of NERD (i.e. heartburn and regurgitation) | 20 mg | Once daily |
| Reflux esophagitis or erosive esophagitis | 40 mg | Once daily for 4-8 weeks |
| Maintenance therapy of healing of reflux esophagitis | 20 mg | Once daily |
| Healing of NSAID associated gastric ulcers | 20 mg | Once daily for 4-8 weeks |
| Risk reduction of NSAID associated gastric ulcers | 20 mg | Once daily |
| Zollinger-Ellison Syndrome | 40 mg | Twice daily |
| H. pylori eradication (Othera® with amoxicillin 1000 mg and clarithromycin 500 mg) | 20 mg | Twice daily for 7 days |
Pediatrics (12 to 17 years)
| Indication | Dose | Frequency |
|---|---|---|
| Gastroesophageal reflux disease (GERD) | ||
| Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) | 20 mg | Once daily for 2-4 weeks |
| Reflux esophagitis or erosive esophagitis | 20 mg or 40 mg | Once daily for 4-8 weeks |
Use in pregnancy & 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.
Geriatric use
Precautions
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.
Contraindications
Esomeprazole is contraindicated in patient with known hypersensitivity to esomeprazole or any other components of this product.
Drug interactions
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.
Preparation
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.
Pharmaceutical precautions
Keep away from the reach of children. Store below 25°C protected from light & moisture. To be taken and sold only on the prescription of a registered physician.
Presentation
No Data
Package quantities
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.
