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Indications/Uses
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.
Dosage/Direction for Use
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.
Peptic ulcer associated with Helicobacter Pylori: See table.
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 hould be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.
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 hould be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.
Administration
Should be taken on an empty stomach.
Contraindications
Omeprazole (PROSEC) is contraindicated in patients with known hypersensitivity to any component of the formulation and with gastric malignancy.
Special Precautions
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.
Use In Pregnancy & Lactation
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.
Adverse Reactions
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.
Drug Interactions
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.
Caution For Usage
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.
The reconstituted solution should not be used if it contains visible particulate matter.
Storage
Prosec: Store at temperatures not exceeding 30°C.
Prosec IV: Store at temperatures not exceeding 25°C. Protect from light.
Prosec IV: Store at temperatures not exceeding 25°C. Protect from light.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Brand
Prosec
Full Details
Dosage Strength
40 mg
Drug Ingredients
- Omeprazole
Drug Packaging
Powder for Injection (I.V.) 1's
Generic Name
Omeprazole
Dosage Form
Powder For Injection (I.V.)
Registration Number
DRP-5657
Drug Classification
Prescription Drug (RX)