Zucapride-M (Dapagliflozin + Metformin)

• Composition :
  Each film coated tablet contains Dapagliflozin 10mg + Metformin 500mg/1000mg SR.
• Indications :
  Dapagliflozin and Metformin HCl Extended-Release Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
• Pharmacodynamics :
  Dapagliflozin: Dapagliflozin is an inhibitor of sodium-glucose co-transporter 2 (SGLT2) that improves glycaemic control in patients with T2DM by reducing renal glucose reabsorption leading to urinary excretion of excess glucose.Metformin-Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
• Dosage and administration :
  One tablet, once daily, with food in the morning.
• Contraindications :
  Patients who have a history of hypersensitivity to dapagliflozin, metformin or any other constituents of the preparation. Patients with severe renal impairment, (eGFR less than 30 mL/min/1.73 m2) end-stage renal disease (ESRD), or patients on dialysis. Metabolic acidosis including diabetic ketoacidosis.
• Precautions and warnings :
  Caution should be exercised, while administering Zucapride-M in patients with lactic acidosis, hypotension, ketoacidosis, acute kidney injury, urosepsis and polynephritis, hypoglycaemia, necrotizing fasciitis of the perineum (Fournier’s Gangrene), genital mycotic infections, vitamin B12 deficiency and bladder cancer.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category C. Safety and effectiveness studies have not been conducted in nursing mothers. Paediatric Use: Safety and effectiveness in children younger than 18 years of age have not been established.
• Drug interactions :
  Dapagliflozin- SGLT2 inhibitors lead to unreliable results in urine glucose test and 1,5-anhydroglucitol (1,5-AG) assay. Metformin- Co-administration with carbonic anhydrase inhibitors may increase the risk of lactic acidosis. Consider more frequent monitoring.Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake.
• Adverse reactions :
  Male and female genital mycotic infections, hypotension, ketoacidosis, nasopharyngitis, UTI, back pain, increased micturition, constipation, dyslipidaemia and influenza. Metformin- Diarrhoea, nausea and vomiting.
• Therapy Area :
  Anti-Diabetic agents