Omicap Capsules (Omeprazole).

• Composition :
  Each capsule contains Omeprazole 20mg.
• Indications :
  For the treatment of GERD.
• Pharmacodynamics :
  Omeprazole inhibits the secretion of gastric acid by irreversibly blocking the enzyme system of H+/K+ ATPase of the gastric parietal cell.
• Dosage and administration :
  One capsule to be taken daily before meals or on empty stomach.
• Contraindications :
  Contraindicated in patients with known hypersensitivity to the active constituents or other any other ingredients of the preparation. In patients with known existing prolongation of cardiac conduction intervals, particularly QT.
• Precautions and warnings :
  Omeprazole may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. Atrophic gastritis: has been noted with long-term therapy This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy. Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category C. There are no adequate and well-controlled studies in human pregnancy. Drug should be used during pregnancy only if clearly needed. 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 Safety and effectiveness in pediatric patients is not established.
• Drug interactions :
  Omeprazole: The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that inhibit CYP2C19 activity- avoid concomitant use. Concomitant treatment with omeprazole (20 mg daily) and digoxin increases the bioavailability of digoxin. Omeprazole increases exposure to phenytoin. CYP3A4 inducers and inhibitors decrease and increase the exposure to omeprazole respectively. Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions. Domperidone: Co-administration of domperidone with potent CYP3A4 inhibitors is contraindicated. Domperidone should not be co-administered with drugs that cause QT prolongation such as amiodarone, disopyramide, haloperidol, quinidine, erythromycin, levofloxacin etc.
• Adverse reactions :
  The most frequent side effects are headache, abdominal pain, dry mouth, , diarrhea, and flatulence, agitation, nervousness.
• Therapy Area :
  Anti-ulcerants_Gastroenterologicals