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Omiflux Capsules (Omeprazole +Domperidone).

  • Each capsule contains Omeprazole 20mg + Domperidone 10mg.
  • For the treatment of GERD not responding to omeprazole alone.
  • Omeprazole inhibits the secretion of gastric acid by irreversibly blocking the enzyme system of H+/K+ ATPase of the gastric parietal cell. Domperidone is a peripheral dopamine D2-receptor antagonist, which regulates the motility of gastric and small intestinal smooth muscle. It increases the duration of antral and duodenal contractions and also LES resting pressure, thus stimulating gastric emptying and is also effective in relief of symptoms of reflux esophagitis.
  • One or two capsules to be taken daily before meals or on empty stomach.
  • 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, having significant electrolyte disturbances, underlying cardiac diseases such as congestive heart failure, moderate or severe liver impairment and prolactin-releasing pituitary tumour (prolactinoma.).
  • Omeprazole, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. 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. Domperidone: Should be used with caution in patients with renal impairment and in patients with cardiovascular abnormalities as prolongation of QT interval has been reported.
  • There are no adequate and well-controlled studies in human pregnancy. Hence, avoid use in pregnancy. Not recommended for use in lactation. Safety and effectiveness in pediatric patients is not established.
  • 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.
  • The most frequent side effects are headache, abdominal pain, dry mouth, diarrhea, and flatulence, agitation, nervousness.
  • Anti-ulcerants_Gastroenterologicals