COMPOSITION:

DAPASIS 5:

Each tablet contains Dapagliflozin Propanediol Monohydrate equivalent to Dapagliflozin 5 mg.

DAPASIS 10:

Each tablet contains Dapagliflozin Propanediol Monohydrate equivalent to Dapagliflozin 10 mg tablet.

 

Mechanism of Action:

Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

INDICATION & USAGE:

Monotherapy: Dapagliflozin propanediol monohydrate is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with T2DM for whom metformin is inappropriate due to contraindications or intolerance.

Add-on combination: Dapagliflozin is indicated in adult patients with T2DM to improve glycemic control in combination with

  • Metformin
  • Sulfonylurea
  • Metformin and a sulfonylurea
  • Sitagliptin (alone or with metformin)
  • Insulin (alone or with metformin)

Add-On Combination in Patients with Cardiovascular Risk Factors or Established Cardiovascular Disease: Dapagliflozin is indicated as an adjunct to diet, exercise, and standard of care therapy to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and CV risk factors or established CV disease.

 

CONTRAINDICATIONS:

History of serious hypersensitivity reaction to Dapagliflozin.

Severe renal impairment, end-stage renal disease, or dialysis.

ADVERSE REACTIONS:

The most common adverse reactions associated are female genital mycotic infections, nasopharyngitis, and urinary tract infections.

 

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