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Indications/Uses
Omeprazole is a proton pump inhibitor indicated for: Peptic Ulcer, Duodenal ulcer associated with H.pylori, Gastric ulcer, Gastro-esophageal reflux disease (GERD), Hypersecretory conditions like: Zollinger-Ellison Syndrome; Prophylaxis of Acid Aspiration, Reflux esophagitis, Dyspepsia.
Dosage/Direction for Use
Omeprazole may be given orally before meals. Omeprazole capsule must be swallowed whole with water and should not be opened, crushed or chewed.
Peptic Ulcer: Omeprazole 20 mg once a day. For severe cases, Omeprazole 40 mg is recommended. Healing usually occurs within 4 weeks for patients with duodenal ulcer and 8 weeks for those with gastric ulcer.
Omeprazole 10 mg to 20 mg once daily may be given for maintenance.
Duodenal Ulcer: Omeprazole 20 mg once a day for 4 to 8 weeks. The healing occurs within 4 weeks in most patients. It may require an additional 4 weeks of therapy for some patients.
Duodenal Ulcer associated with H. pylori: Triple therapy: Omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice a day for 10 days. If an ulcer is present at the initiation of therapy, continue Omeprazole 20 mg for an additional 18 days.
Omeprazole 20 mg plus clarithromycin 250 mg plus metronidazole 500 mg or (linidazole 500 mg) each given twice a day for one week or
Omeprazole 20 mg capsules once a day plus amoxicillin 500 mg plus metronidazole 500 mg both given three times a day for one week.
Dual Therapy: Omeprazole 40 mg once a day plus clarithromycin 500 mg three times a day for 14 days. If an ulcer is present at the initiation of therapy, continue Omeprazole 20 mg for an additional 14 days.
Omeprazole 40 mg once a day plus amoxicillin 750 mg twice a day, given for 2 weeks.
Gastric Ulcer: Omeprazole 20 mg once a day for 4 weeks. For patients with poorly responsive gastric ulcer, Omeprazole 40 mg once a day for 8 weeks.
Gastro-Esophageal Reflux Disease (GERD): Omeprazole 20 mg 1 to 2 capsules once a day, given 4 to 12 weeks.
Dyspepsia: Omeprazole 10 mg once a day could be considered as a starting or initial dose because patients may respond adequately to this dose. For patients with epigastric pain or discomfort with or without heartburn, Omeprazole 20 mg once a day is the recommended dosage for 4 weeks. If after 4 weeks of treatment with Omeprazole 20 mg once a day has not been achieved, it is recommended for further investigation.
Impaired Hepatic Function: Some recommend that the maximum daily dose for patients with impaired hepatic function is reduced to 20 mg Omeprazole 10-20 mg once a day may be sufficient for patients with impaired hepatic function. For the elderly dose adjustment is not needed.
Patients with impaired renal function dose adjustment is needed.
Or as prescribed by a physician.
Peptic Ulcer: Omeprazole 20 mg once a day. For severe cases, Omeprazole 40 mg is recommended. Healing usually occurs within 4 weeks for patients with duodenal ulcer and 8 weeks for those with gastric ulcer.
Omeprazole 10 mg to 20 mg once daily may be given for maintenance.
Duodenal Ulcer: Omeprazole 20 mg once a day for 4 to 8 weeks. The healing occurs within 4 weeks in most patients. It may require an additional 4 weeks of therapy for some patients.
Duodenal Ulcer associated with H. pylori: Triple therapy: Omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice a day for 10 days. If an ulcer is present at the initiation of therapy, continue Omeprazole 20 mg for an additional 18 days.
Omeprazole 20 mg plus clarithromycin 250 mg plus metronidazole 500 mg or (linidazole 500 mg) each given twice a day for one week or
Omeprazole 20 mg capsules once a day plus amoxicillin 500 mg plus metronidazole 500 mg both given three times a day for one week.
Dual Therapy: Omeprazole 40 mg once a day plus clarithromycin 500 mg three times a day for 14 days. If an ulcer is present at the initiation of therapy, continue Omeprazole 20 mg for an additional 14 days.
Omeprazole 40 mg once a day plus amoxicillin 750 mg twice a day, given for 2 weeks.
Gastric Ulcer: Omeprazole 20 mg once a day for 4 weeks. For patients with poorly responsive gastric ulcer, Omeprazole 40 mg once a day for 8 weeks.
Gastro-Esophageal Reflux Disease (GERD): Omeprazole 20 mg 1 to 2 capsules once a day, given 4 to 12 weeks.
Dyspepsia: Omeprazole 10 mg once a day could be considered as a starting or initial dose because patients may respond adequately to this dose. For patients with epigastric pain or discomfort with or without heartburn, Omeprazole 20 mg once a day is the recommended dosage for 4 weeks. If after 4 weeks of treatment with Omeprazole 20 mg once a day has not been achieved, it is recommended for further investigation.
Impaired Hepatic Function: Some recommend that the maximum daily dose for patients with impaired hepatic function is reduced to 20 mg Omeprazole 10-20 mg once a day may be sufficient for patients with impaired hepatic function. For the elderly dose adjustment is not needed.
Patients with impaired renal function dose adjustment is needed.
Or as prescribed by a physician.
Overdosage
Omeprazole overdosage has been reported rarely. Doses ranged from 320 to 900 mg (16 to 45 times of the usual recommended dose). Symptoms were transient and no serious clinical outcome has been reported.
Nausea, vomiting, dizziness, abdominal pain, diarrhea, headache, apathy, depression and confusion are reported from omeprazole overdosage.
No specific antidote for omeprazole overdosage is known.
Omeprazole are extensively protein bound and are not readily dialyzable. Treatment should be symptomatic and supportive.
Nausea, vomiting, dizziness, abdominal pain, diarrhea, headache, apathy, depression and confusion are reported from omeprazole overdosage.
No specific antidote for omeprazole overdosage is known.
Omeprazole are extensively protein bound and are not readily dialyzable. Treatment should be symptomatic and supportive.
Administration
Should be taken with food: Take immediately before meals.
Contraindications
Patients with known hypersensitivity to omeprazole.
Special Precautions
Omeprazole inhibits the metabolism of some drugs metabolized by the hepatic cytochrome P450 enzyme system and may increase plasma concentrations of Diazepam, Phenytoin and Warfarin.
Before giving omeprazole to patient with gastric ulcers the possibility of malignancy should be excluded since it may mask symptoms of delay diagnosis.
Before giving omeprazole to patient with gastric ulcers the possibility of malignancy should be excluded since it may mask symptoms of delay diagnosis.
Use In Pregnancy & Lactation
Animal studies show risk but human studies are inadequate or lacking or no studies in humans or animals.
Direct pregnant or lactating women to consult a physician before use.
Direct pregnant or lactating women to consult a physician before use.
Adverse Reactions
Most frequently reported adverse effects: diarrhea, skin rashes and headache. Effects on the Central Nervous System, including reversible confusional states in severely ill patients.
Other adverse effects reported rarely include: Arthralgia and myalgia, blood disorders including leukopenia and thrombocytopenia, interstitial nephritis and hepatoxicity.
Other adverse effects reported rarely include: Arthralgia and myalgia, blood disorders including leukopenia and thrombocytopenia, interstitial nephritis and hepatoxicity.
Drug Interactions
Omeprazole may interfere with the absorption of drugs like: ketoconazole, ampicillin, iron salts, digoxin, cyanocobalamin where gastric pH is an important determinant of bioavailability.
There are clinical reports of interaction with other drugs like: cyclosporine, disulfiram, benzodiazepines which are metabolized via the cytochrome P450 (CYP450) system.
Coadministration of omeprazole and clarithromycin may result in increase in plasma levels.
Omeprazole increases the half-life of diazepam, probably caused by inhibition oxidative metabolism. Plasma levels were also increased and total clearance of diazepam was decreased.
Omeprazole reduced the plasma clearance of phenytoin and increased its half-life caused by inhibilion of oxidative metabolism.
Coadministration of sucralfate may delay absorption and reduced omeprazole bioavailabillty. Therefore, take omeprazole 30 minutes prior to sucralfate.
There are clinical reports of interaction with other drugs like: cyclosporine, disulfiram, benzodiazepines which are metabolized via the cytochrome P450 (CYP450) system.
Coadministration of omeprazole and clarithromycin may result in increase in plasma levels.
Omeprazole increases the half-life of diazepam, probably caused by inhibition oxidative metabolism. Plasma levels were also increased and total clearance of diazepam was decreased.
Omeprazole reduced the plasma clearance of phenytoin and increased its half-life caused by inhibilion of oxidative metabolism.
Coadministration of sucralfate may delay absorption and reduced omeprazole bioavailabillty. Therefore, take omeprazole 30 minutes prior to sucralfate.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Absorption/Distribution: Omeprazole is a proton pump inhibitor and thus prevents secretion of gastric acid. It is rapidly absorbed, but to a variable extent following oral administration. Omeprazole absorption is not affected by food and it is acid-labile. Omeprazole bioavailability is 30% to 40%, it increases slightly upon repeat administration. In the elderly patients and in patients with impaired hepatic function omeprazole bioavailability may increase, but is not markedly affected in patients with renal impairment. Omeprazole is highly bound to plasma proteins about 95%.
Metabolism/Excretion: Omeprazole is extensively metabolized by the liver. Some metabolites have been identified. These metabolites have inadequate or no antisecretory activity. The elimination half-life from plasma is short at about 0.5 to 3 hours while the acid inhibitory effect is much longer that lasts more than 24 hours. Once the omeprazole is discontinued, secretory activity returns over 3 to 5 days. Omeprazole is rapidly eliminated; approximately 77% is eliminated in the urine. The remainder of the dose is excreted in the feces.
Metabolism/Excretion: Omeprazole is extensively metabolized by the liver. Some metabolites have been identified. These metabolites have inadequate or no antisecretory activity. The elimination half-life from plasma is short at about 0.5 to 3 hours while the acid inhibitory effect is much longer that lasts more than 24 hours. Once the omeprazole is discontinued, secretory activity returns over 3 to 5 days. Omeprazole is rapidly eliminated; approximately 77% is eliminated in the urine. The remainder of the dose is excreted in the feces.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Brand
Mepraz
Full Details
Dosage Strength
40 mg
Drug Ingredients
- Omeprazole
Drug Packaging
Capsule 20's
Generic Name
Omeprazole
Dosage Form
Capsule
Registration Number
DRP-3072
Drug Classification
Prescription Drug (RX)