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Dapagliflozin

Generic Name
Dapagliflozin
Brand Names
Edistride, Farxiga, Forxiga, Qtern, Qternmet, Xigduo, Dapagliflozin Viatris
Drug Type
Small Molecule
Chemical Formula
C21H25ClO6
CAS Number
461432-26-8
Unique Ingredient Identifier
1ULL0QJ8UC

Overview

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and it was the first SLGT2 inhibitor to be approved. indicated for managing diabetes mellitus type 2. 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. Dapagliflozin has been investigated either as monotherapy or as an adjunct treatment with insulin or other oral hypoglycemic agents. Dapagliflozin was originally approved by the FDA on Jan 08, 2014, to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. It was later approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease in April 2021.

Background

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and it was the first SLGT2 inhibitor to be approved. indicated for managing diabetes mellitus type 2. 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. Dapagliflozin has been investigated either as monotherapy or as an adjunct treatment with insulin or other oral hypoglycemic agents. Dapagliflozin was originally approved by the FDA on Jan 08, 2014, to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. It was later approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease in April 2021.

Indication

Dapagliflozin is indicated as an adjunct treatment to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.For patients with chronic kidney disease at risk of progression, dapagliflozin in used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure. Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Combination products with dapagliflozin also exist, either as a dapagliflozin-saxagliptin or dapagliflozin-metformin hydrochloride formulation. Both are used as an adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Associated Conditions

  • Cardiovascular Mortality
  • End Stage Renal Disease (ESRD)
  • Hospitalizations
  • Type 2 Diabetes Mellitus
  • Decreased estimated glomerular filtration rate
  • Hospitalization due to cardiac failure

FDA Approved Products

XIGDUO XR
Manufacturer:AstraZeneca Pharmaceuticals LP
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2023/09/12
NDC:0310-6225
DAPAGLIFLOZIN
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/02/06
NDC:63629-3253
XIGDUO XR
Manufacturer:AstraZeneca Pharmaceuticals LP
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/09/12
NDC:0310-6280
QTERN
Manufacturer:AstraZeneca Pharmaceuticals LP
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/09/29
NDC:0310-6770
FARXIGA
Manufacturer:AstraZeneca Pharmaceuticals LP
Route:ORAL
Strength:5 mg in 1 1
Approved: 2024/01/15
NDC:0310-6205

Singapore Approved Products

XIGDUO XR TABLETS 5MG/500MG
Manufacturer:AstraZeneca Pharmaceuticals LP, Merck Sante (Drug Product Intermediate - Metformin), Merck Sante S.A.S. (Drug Product Intermediate – Metformin)
Form:TABLET, FILM COATED, EXTENDED RELEASE
Strength:5mg
Online:Yes
Approved: 2016/08/30
Approval:SIN15077P
SIDAPVIA FIXED DOSE COMBINATION TABLET 10 MG/100 MG
Manufacturer:SK Chemicals Co, Ltd (1346)
Form:TABLET, FILM COATED
Strength:10mg
Online:Yes
Approved: 2024/02/20
Approval:SIN16958P
XIGDUO XR TABLETS 5MG/1000MG
Manufacturer:AstraZeneca Pharmaceuticals LP, Merck Sante (Drug Product Intermediate - Metformin), Merck Sante S.A.S. (Drug Product Intermediate – Metformin)
Form:TABLET, FILM COATED, EXTENDED RELEASE
Strength:5mg
Online:Yes
Approved: 2016/08/30
Approval:SIN15080P
FORXIGA TABLET 5MG
Manufacturer:AstraZeneca Pharmaceuticals LP, AstraZeneca Pharmaceutical Co. Ltd (Primary and Secondary packager)
Form:TABLET, FILM COATED
Strength:5mg
Online:Yes
Approved: 2014/04/28
Approval:SIN14541P
FORXIGA TABLET 10mg
Manufacturer:AstraZeneca Pharmaceuticals LP, AstraZeneca Pharmaceutical Co. Ltd (Primary and Secondary packager)
Form:TABLET, FILM COATED
Strength:10mg
Online:Yes
Approved: 2014/04/28
Approval:SIN14542P

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