Helirab D Capsules (Rabeprazole + Domperidone).

• Composition :
  Each SR capsule contains Rabeprazole sodium 20 mg + Domperidone 30 mg.
• Indications :
  Indicated for the treatment of Gastroesophageal reflux disease (GERD) not responding adequately to rabeprazole alone.
• Pharmacodynamics :
  Rabeprazole belongs to a class of anti-secretory 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. Domperidone is a dopamine antagonist with anti-emetic properties.
• Dosage and administration :
  One capsule once daily before food for 4 - 8 weeks or as directed by the physician.
• Contraindications :
  Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation. Domperidone is contraindicated in Known hypersensitivity to domperidone or any of the excipients. In patients with moderate or severe hepatic impairment. In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure.
• Precautions and warnings :
  Concomitant Use with Warfarin: Monitor for increases in INR and prothrombin time. Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole. Co-administration of atazanavir with rabeprazole is not recommended.
• Use in pregnancy, lactation & pediatrics :
  The safety and efficacy in this population has not been established. Rabeprazole is contraindicated during pregnancy. Rabeprazole must not be used during breast feeding. Rabeprazole is not recommended for use in children.
• Drug interactions :
  There have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including rabeprazole, and warfarin concomitantly. Increases in the INR and prothrombin time may lead to abnormal bleeding and even death. The results of this interaction study should be taken into account when prescribing domperidone concomitantly with strong CYP3A4 inhibitors, e.g. ketoconazole, ritonavir and erythromycin.
• Adverse reactions :
  Most common side effects are diarrhea, abdominal pain, asthenia, flatulence, rash and dry mouth.
• Therapy Area :
  Anti-ulcerants_Gastroenterologicals