Dexiglofozin

Pharmaceutical

Product Details:

Brand Name: Dexiglofozin 10mg Tablet

Composition

Each Dexiglofozin 10 mg Tablet contains: 

  dapagliflozin ........................................................ 10 mg                                                           

Therapeutic Indications                 

  • Type 2 Diabetes Mellitus:
      • as an adjunct to diet and exercise to improve glycemic control. 
      • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. 
  • Heart Failure:
    •  to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II-IV)                                                        

Dosage and Administration   

    • Assess renal function before initiating and then as clinically indicated. 
  • Type 2 Diabetes Mellitus:
      • To improve glycemic control the recommended starting dose is 5 mg once daily, taken in the morning. Increase dose to 10 mg once daily in patients tolerating 5 mg who require additional glycemic control. 
      • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors, the recommended dose is 10 mg once daily. 
      • Dexiglofozin is not recommended for glycemic control when the eGFR is less than 45 mL/min/1.73 m2
  • Heart Failure:
    • The recommended dose of Dexiglofozin is 10 mg once daily 

Contraindications         

  • History of serious hypersensitivity reaction to Dexiglofozin. 
  • Severe renal impairment (eGFR less than 30 mL/min/1.73 m2 in patients who are being treated for glycemic control without established cardiovascular disease or cardiovascular risk factors. 
  •  Patients on dialysis                                                         

Warnings and precautions            

  • Volume depletion: Before initiating Dexiglofozin, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. 
  • Ketoacidosis in Patients with Diabetes Mellitus: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis regardless of blood glucose level. If suspected, discontinue Dexiglofozin, evaluate and treat promptly. Before initiating Dexiglofozin, consider risk factors for ketoacidosis. Patients on Dexiglofozin may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. 
  • Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treatment promptly, if indicated. 
  • Hypoglycemia: Consider a lower dose of insulin or the insulin
  • secretagogue to reduce the risk of hypoglycemia when used in combination with Dexiglofozin. 
  • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in patients with diabetes, both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perianal area, along with fever or malaise. If suspected, institute prompt treatment. 
  • Genital Mycotic Infections: Monitor and treat if indicated.                                                        

Undesirable Effects        

  • The most common adverse reactions associated with Dexiglofozin (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.                                                                     

Pharmacological Properties        

    Dexiglofozin is a sodium-glucose cotransporter 2 inhibitor indicated for managing diabetes mellitus type,  When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose reabsorption in the proximal tubule of the nephron and causing glycosuria                                                   

Packaging                

   Dexiglofozin 10 mg Tablet: Box containing 3 blisters of 10 tablets each

 

Brand Name: Dexiglofozin 5mg Tablet

Composition

Each Dexiglofozin 5mg Tablet contains: 

  dapagliflozin ........................................................ 5mg                                                           

Therapeutic Indications                 

  • Type 2 Diabetes Mellitus:
      • as an adjunct to diet and exercise to improve glycemic control. 
      • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. 
  • Heart Failure:
    •  to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II-IV)                                                        

Dosage and Administration   

    • Assess renal function before initiating and then as clinically indicated. 
  • Type 2 Diabetes Mellitus:
      • To improve glycemic control the recommended starting dose is 5 mg once daily, taken in the morning. Increase dose to 10 mg once daily in patients tolerating 5 mg who require additional glycemic control. 
      • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors, the recommended dose is 10 mg once daily. 
      • Dexiglofozin is not recommended for glycemic control when the eGFR is less than 45 mL/min/1.73 m2
  • Heart Failure:
    • The recommended dose of Dexiglofozin is 10 mg once daily 

Contraindications         

  • History of serious hypersensitivity reaction to Dexiglofozin. 
  • Severe renal impairment (eGFR less than 30 mL/min/1.73 m2 in patients who are being treated for glycemic control without established cardiovascular disease or cardiovascular risk factors. 
  •  Patients on dialysis                                                         

Warnings and precautions            

  • Volume depletion: Before initiating Dexiglofozin, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. 
  • Ketoacidosis in Patients with Diabetes Mellitus: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis regardless of blood glucose level. If suspected, discontinue Dexiglofozin, evaluate and treat promptly. Before initiating Dexiglofozin, consider risk factors for ketoacidosis. Patients on Dexiglofozin may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. 
  • Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treatment promptly, if indicated. 
  • Hypoglycemia: Consider a lower dose of insulin or the insulin
  • secretagogue to reduce the risk of hypoglycemia when used in combination with Dexiglofozin. 
  • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in patients with diabetes, both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perianal area, along with fever or malaise. If suspected, institute prompt treatment. 
  • Genital Mycotic Infections: Monitor and treat if indicated.                                                        

Undesirable Effects        

  • The most common adverse reactions associated with Dexiglofozin (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.                                                                     

Pharmacological Properties        

    Dexiglofozin is a sodium-glucose cotransporter 2 inhibitor indicated for managing diabetes mellitus type,  When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose reabsorption in the proximal tubule of the nephron and causing glycosuria                                                   

Packaging                

   Dexiglofozin 5mg Tablet: Box containing 3 blisters of 10 tablets each