RISEK Capsule

in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

- In common with the use of other inhibitors of acid secretion or antacids, the absorption of ketoconazole, and itraconazole can decrease during treatment with omeprazole due to decreased intragastric acidity during treatment with omeprazole.

- Omeprazole is metabolized by CYP2C19. Thus, when omeprazole is combined with drugs metabolized by CYP2C19, such as diazepam, citalopram, impiramine, clomipramine, phenytoin etc., the plasma concentrations of these drugs may be increased and a dose redction could be needed.

There are no adequate or well-controlled studies in pregnant women. Omeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether omeprazole is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from omeprazole, a decision should be made whether, to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

General:

- When gastric ulcer is suspected, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.

- Prior to initiation of dual or triple therapy, the physician should consider the patient with known hypersensitivity reactions to penicillin, macrolides and other antibiotics.

Hepatic impairment:

Consideration should be given to reducing the dose of omeprazole in patients with impaired hepatic function as bioavailability an half-life can increase.

Pregnancy:

There are no adequate or well-controlled studies in pregnant women. Omeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether omeprazole is excreted in human milk. Because may drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from omeprazole, a decision should be made whether, to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Drug interactions

- In common with the use of other inhibitors of acid secretion or antacids, the absorption of ketoconazole, and itraconazole can decrease during treatment with omeprazole due to decreased intragastric acidity during treatment with omeprazole.

- Omeprazole is metabolized by CYP2C19. Thus, when omeprazole is combined with drugs metabolized by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc., the plasma concentrations of these drugs may be increased and a dose reduction could be needed.

Omeprazole reduces gastric acid secretion through a unique mechanism of action. Omeprazole belongs to a new class of anti-secretory compounds, the substituted benzimidazoles that do not exhibit anti-cholinergic or histamine antagonistic properties. It inhibits secretion of gastric acid by irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphatase(H+/K+ ATPase), the proton pump of the gastric parietal cell. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.