Helirab Injection (Rabeprazole).

• Composition :
  Injection rabeprazole sodium 20 mg.
• Indications :
  For the treatment of gastritis & duodenal ulcer, gastroesophagal reflux disease (GERD) as an alternative to oral therapy in patients who are unable to take oral proton pump inhibitor.
• Dosage and administration :
  I.V. administration of the content of one vial (20 mg rabeprazole) once daily.
• Contraindications :
  Hypersensitivity to rabeprazole, substituted benzimidazoles or to any other excipients of the formulation.
• Precautions and warnings :
  Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy, Patients treated with a proton pump inhibitor and warfarin concomitantly may need to be monitored for increases in INR (International Normalised Ratio) and prothrombin time, Acute interstitial nephritis has been observed in patients taking rabeprazole sodium, Long-term use, longer than 3 years may lead to malabsorption or a deficiency of cyanocobalamin (vitamin B-12). Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures.
• Use in pregnancy, lactation & pediatrics :
  Category B. There are no adequate and well controlled studies with rabeprazole in pregnant women, should be used if potential benefit justifies the risk, caution should be exercised when rabeprazole is administered to a nursing woman, caution should be exercised when rabeprazole sodium is administered to a nursing woman. Safety and effectiveness in paediatric patients have not been established.
• Drug interactions :
  Increased INR and prothrombin times have been reported in concomitant use with warfarin. Patients need to be monitored, Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro, inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts, digoxin, and mycophenolate mofetil), Rabeprazole may reduce the plasma levels of atazanavir and may increase serum level of methotrexate.
• Adverse reactions :
  In adults: headache, diarrhoea, abdominal pain, asthenia.
• Therapy Area :
  Anti-ulcerants_Gastroenterologicals
• Mechanism of Action :
  Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+ K+ ATPase at the secretory surface of the gastric parietal cell.