Othera Eco^®

Othera Eco 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.

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Indication
Othera Eco 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

Route of administration: Othera Eco is taken orally with or without food.

Adults (from the age of 18 years)

Pediatrics (12 to 17 years)

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.

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.

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.

Esomeprazole is contraindicated in patient with known hypersensitivity to esomeprazole or any other components of this product.

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.

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.

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Othera Eco 20 mg capsule: Each Delayed Release Capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg in enteric coated micro pellets.
Othera Eco 40 mg capsule: Each Delayed Release Capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg in enteric coated micro pellets.

Storage
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.

Packing
Othera Eco 20 mg capsule: Carton of 100 capsules in Alu-Alu blister pack.
Othera Eco 40 mg capsule: Carton of 60 capsules in Alu-Alu blister pack.