Prosec/Prosec IV

Omeprazole.

Prosec: Each capsule contains Omeprazole BP 20 mg as enteric coated pellets.
Omeprazole (Prosec), the substituted benzimadole, is an inhibitor of gastric acid secretion. Omeprazole does not exhibit anticholinergic or H₂-histamine antagonistic properties, but inhibits the secretion of gastric acid by blocking the H⁺/K⁺ATPase (hydrogen-potassium-adenosine triphosphatase) enzyme system, the so-called "proton pump" of the gastric parietal cell.
After oral administration of Omeprazole (Prosec) absorption is rapid, onset occurs within 1 hour and peaks within 2 hours.
Inhibition of secretion is about 50% of maximum at 24 hours, and the duration of inhibition lasts not longer than 72 hours.
The antisecretory effect thus lasts far longer than would be expected from the very short (<1 hour) plasma half-life, apparently due to prolonged binding to the parietal H⁺K⁺ATPase enzyme. When the drug is discontinued, secretory activity return over 3 to 5 days.
Prosec IV: Each vial contains sterile powder of Omeprazole (as sodium) BP equivalent to 40 mg Omeprazole.
Each ampoule contains 10 mL of Sterile Water for Injection BP for reconstitution.
Omeprazole (PROSEC), the substituted benzimidazole, is an inhibitor of gastric acid secretion. Omeprazole does not exhibit anticholinergic or H₂-histamine antagonistic properties, but inhibits the secretion of gastric acid by blocking the H⁺/K⁺ATPase (hydrogen-potassium adenosine triphosphatase) enzyme system, the so-called "proton pump" of the gastric parietal cell.

Duodenal ulcer, gastric ulcer, NSAID-associated complications, peptic ulcer associated with Helicobacter pylori, gastro-esophageal reflux disease, acid reflux disease, Zollinger-Ellison syndrome, prevention of acid aspiration syndrome, acid related dyspepsia.

Prosec: NSAID-associated complications: NSAID-associated duodenal or gastric ulcer and gastroduodenal erosions, 20 mg once daily for 4 weeks if not fully healed; prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers, gastroduodenal lesions, or dyspeptic symptoms who require continued NSAID treatment, 20 mg once daily.
Peptic ulcer associated with Helicobacter Pylori: See table.

Click on icon to see table/diagram/image

For Acid-related dyspepsia: 10 mg-20 mg daily for 2 to 4 weeks.
For Gastro-esophageal reflux disease: 20 mg-40 mg daily for 4 to 12 weeks; thereafter maintenance therapy can be continued with 20 mg daily. (0.7 mg-1.4 mg per kg body weight daily up to a maximum daily dose of 40 mg for 4 to 12 weeks for children).
For Peptic ulcer disease: Single daily dose of 20 mg or 40 mg in severe cases. Treatment is continued for 4 weeks for duodenal cancer and 8 weeks for gastric ulcer. 10 mg-20 mg daily for maintenance.
For Prophylaxis of acid aspiration: 40 mg the evening before surgery and 40 mg on the day of surgery 2 to 6 hours before the procedure.
Omeprazole should be taken before meals.
Or as prescribed by the physician.
Prosec IV: Duodenal ulcer, gastric ulcer and gastro-esophageal reflux disease: 40 mg once daily until oral administration is possible.
Prophylaxis of acid aspiration: 40 mg completed 1 hour before surgery.
In patients with Zollinger-Ellison syndrome: the recommended initial dose is 60 mg daily. Higher daily doses may be required and the doses should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.

Omeprazole (PROSEC) is contraindicated in patients with known hypersensitivity to any component of the formulation and with gastric malignancy.

Symptomatic response to therapy with Omeprazole (PROSEC) does not preclude the presence of gastric malignancy. 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.

There are no adequate or well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Omeprazole is excreted in breast milk. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Omeprazole (PROSEC) is well tolerated and adverse reactions are generally mild and reversible. Nausea, diarrhea, constipation, flatulence, abdominal pain, dizziness, headache, skin rashes may occur rarely. Reversible confusional states, agitation, depression and hallucinations on severely ill patients. Adverse effects reported are arthralgia, paraesthesia, aggression, blurred vision, taste disturbances, peripheral edema, hyponatremia, agranulocytosis, leucopenia, thrombocytopenia, interstitial nephritis and hepatotoxicity.

Omeprazole (PROSEC) can prolong the elimination of diazepam, phenytoin, warfarin and other vitamin K antagonists. Decreased gastric acidity caused by Omeprazole may affect the absorption of other drugs (such as dasatinib, ketoconazole and itraconazole) when given concomitantly.

Prosec IV: The solution for IV injection is prepared by adding 10 mL Sterile Water for Injection to the 40 mg vial of Omeprazole. After reconstitution, the injection should be given over 5 minutes or at least by 2.5 minutes at a maximum rate of 4 mL per minute. The solution should be used within 4 hours of reconstitution when stored in original vial in a cool place.
The reconstituted solution should not be used if it contains visible particulate matter.

Prosec: Store at temperatures not exceeding 30°C.
Prosec IV: Store at temperatures not exceeding 25°C. Protect from light.

Antacids, Antireflux Agents & Antiulcerants

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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