Rabiros-L (Rabeprazole + Levosulpiride).

• Composition :
  Each hard gelatin capsule contains: Rabeprazole Sodium 20 mg and Levosulpiride 75 mg (as sustained-release pellets)
• Indications :
  For the treatment of Gastroesophageal Reflux Disease (GERD)
• Pharmacodynamics :
  Rabeprazole belongs to a class of anti-secretory 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. Levosulpiride is a sulpiride isomer that exerts its prokinetic action through a dual mechanism: D (2) dopamine receptor antagonist and a serotonin 5HT (4) receptor agonist, conferring this drug with a cholinergic effect.
• Dosage and administration :
  One capsule once a day, before food.
• Contraindications :
  In patients with known hypersensitivity to Rabeprazole sodium, Domperidone, or to any excipient used in the formulation. Severe renal or hepatic insufficiency
• 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 diarrhoea, 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 Levosulpiride must not be used in presence of GI haemorrhages, mechanical obstructions or perforations, to be cautious when administering Levosulpiride altogether with alcohol intake
• Use in pregnancy, lactation & pediatrics :
  The safety of this combination has not been established in these populations and hence should not be used.
• Drug interactions :
  Rabeprazole - Monitor for increases in INR and prothrombin 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. Levosulpiride: Reduced bioavailability with sucralfate, aluminium- and magnesium-containing antacids. The effects on gastric motility may be antagonized by anticholinergic drugs, narcotics and analgesics. Caution should be exercised when administering levosulpiride together with psycho-pharmaceutical drugs since an increase of undesired effects may occur.
• Adverse reactions :
  The most common adverse events are headache, dizziness, diarrhoea, peripheral oedema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, constipation, abdominal pain, myalgia arthralgia and drowsiness.
• Therapy Area :
  Anti-ulcerants_Gastroenterologicals