Ometor 20 mg Capsule: Each capsule contains Omeprazole BP 20 mg as enteric coated Pellets.
Ometor (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.
Ometor 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
Capsule: Ometor 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 week treatment. Omeprazole has also been used in a dose of 20 mg daily in patients with reflux esophagitis refractory to other therapy. Healing usually occurred within 8 weeks. Patients can be continued at a dosage of 20 mg once daily. Acid reflux disease for long-term management, Omeprazole 10 mg once daily is recommended, increasing to 20 mg if symptoms return. Duodenal and benign gastric ulcers. The usual dose is 20 mg Omeprazole once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. The majority of patients with benign gastric ulcer are healed after 8 weeks. In severe or recurrent cases the dose may be increased to 40 mg Omeprazole daily. Long-term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dosage of 20 mg Omeprazole once daily. For prevention of relapse in patientswithduodenal ulcer, the recommended dose is Omeprazole 10 mg once daily, increasing to 20 mg once if symptoms return. Helicobacter pylori eradication Omeprazole is recommended at a dose of 20 mg once daily or 20 mg in peptic ulcer disease twice daily in association with antimicrobial agents Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for 7 to 14 days. Prophylaxis of acid aspiration For patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is Omeprazole 40 mg on the evening before surgery followed by Omeprazole 40 mg 2-6 hours prior to surgery. Zollinger-Ellison syndrome The recommended initial dosage is 60 mg Omeprazole once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given twice daily. Children GERD or other acid-related disorder Age Body Weight: Dose > 1 year 10 – 20 kg 10 mg once daily, if needed, 20 mg once daily > 2 year > 20 kg 20 mg once daily, if needed, 40 mg once daily
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.
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.
Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy.
Use in pregnancy & 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.
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.
Store in a cool and dry place. Protect from light and moisture. Keep out of reach of children.
Ometor 20 mg Capsule : Each box contains 6 X 10’s capsule in Alu-Alu Blister strip.