Rabiros-IT (Rabeprazole + Itopride).

• Composition :
  Each capsule contains Rabeprazole 20 mg + Itopride (150mg)
• Indications :
  For the treatment of Gastroesophageal Reflux Disease (GERD).
• Dosage and administration :
  One capsule once daily before food, for 4-8 weeks or as directed by the physician.
• Contraindications :
  In patients with known hypersensitivity to rabeprazole sodium, domperidone, or to any excipient used in the formulation. should not be used in patients in whom an increase in gastrointestinal motility could be harmful, e.g. gastrointestinal hemorrhage, mechanical obstruction or perforation.
• Precautions and warnings :
  Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy, Acute interstitial nephritis has been observed in patients taking PPIs PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea, Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Since the elimination half-life of domperidone is prolonged in severe renal impairment, dose should be reduced. Domperidone is not recommended for chronic use or for the routine prophylaxis of postoperative nausea and vomiting. Itopride enhances the action of acetylcholine and may produce cholinergic side effects
• Use in pregnancy, lactation & pediatrics :
  The safety and efficacy in this population has not been established. Hence not indicated in these population. Safety of this product in children under the age of 16 has not been established.
• Drug interactions :
  Rabeprazole - Monitor for increases in INR and prothombin time, inhibits cyclosporine metabolism, inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability, may reduce the plasma levels of atazanavir and may increase serum level of methotrexate. Itopride – anticholinergic drugs may reduce the action of Anticholinergic drugs may reduce the action of Itopride. No changes in protein binding have been seen with coadministration of warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine, and nicardipine hydrochloride
• Adverse reactions :
  : Most common side effects are somnolence, dizziness, dry mouth and blurring of vision, Diarrhea.
• Therapy Area :
  Anti-ulcerants_Gastroenterologicals
• Mechanism of Action :
  Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors- PPI) that suppress gastric acid secretion by inhibiting the gastric H+, K+ATPase at the secretory surface of the gastric parietal cell. Domperidone is a dopamine antagonist (blocking both D1 & D2 receptors). Itopride hydrochloride activates gastrointestinal propulsive motility due to its dopamine D2 antagonizing activity and acetylcholinesterase inhibitory activity. Itopride activates acetylcholine release and inhibits its degradation.