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Today: Dec 09, 2019

Omecare®

Omeprazole BP 20 mg

 

COMPOSITION
Omecare® 20 Capsule: Each capsule contains Omeprazole BP 20 mg as enteric coated granules.

PHARMACOLOGY
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. Omeprazole inhibits secretion of gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system, the so called 'Proton Pump' of the gastric parietal cell. It is an effective treatment for gastric and duodenal ulcers and particularly for erosive reflux esophagitis.

Orally administered Omeprazole is absorbed rapidly but to a variable extent. Following absorption Omeprazole is almost completely metabolized and rapidly eliminated mostly in the urine. Although the elimination half-life from plasma is short, being reported to be 0.5 to 1.5 hours, its duration of action with regard to inhibition of acid secretion is much longer and it is suggested that its distribution to the tissues particularly to the gastric parietal cells accounts for this action. Omeprazole is highly bound (about 95%) to plasma proteins.

INDICATION
Omecare® capsule is indicated for gastroesophageal reflux disease including reflux esophagitis, acid reflux disease, duodenal and benign gastric ulcers, Helicobacter pylori eradication in peptic ulcer disease, prophylaxis of acid aspiration, Zollinger-Ellison Syndrome (ZES) and for the treatment of NSAID associated gastric ulcers, duodenal ulcers or gastroduodenal erosions.

DOSAGE AND ADMINISTRATION
Omeprazole should be taken before meal.

Gastroesophageal reflux disease The usual dosage is 20 mg Omeprazole once daily. The majority including reflux esophagitis of patients are healed after 4 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks treatment. Omeprazole has also been used in a dose of 20mg twice daily in patients with reflux esophagitis refractory

CONTRAINDICATION AND WARNING
There are no known contraindications to the use of Omeprazole. When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with Omeprazole is instituted as treatment may alleviate symptoms and delay diagnosis.

PRECAUTION
Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.

USE IN PREGNANCY AND LACTATION
Results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

SIDE EFFECT
Omeprazole is well tolerated. Nausea, diarrhoea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

DRUG INTERACTION
Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. Reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to treatment. There is no evidence of interaction with theophylline, propranolol or antacids.

OVERDOSE
Symptoms were transient, and no serious clinical outcome has been reported with Omeprazole overdose. No specific antidote for Omeprazole overdose is known. Omeprazole is extensively bound with protein and is, therefore, not readily dialyzable. In the event of overdose, treatment should be symptomatic and supportive.

STORAGE CONDITION
Store in a cool (below 250C and dry place, protected from light.

HOW SUPPLIED
Omecare® 20 Capsule: Box containing 96's capsules in strip pack.

 

Manufactured by :

MOMTAZ Pharmaceuticals Limited

 


Design & Developed at BD HOST IT.