Empagliflozin/metformin

Empagliflozin/metformin, sold under the brand name Synjardy among others, is a fixed-dose combination anti-diabetic medication used to treat type 2 diabetes. It contains empagliflozin and metformin hydrochloride.[4][5] It is taken by mouth.[4][5]

Empagliflozin/metformin
Combination of
EmpagliflozinSGLT2 inhibitor
Metformin HydrochlorideAnti-diabetic biguanide
Clinical data
Trade namesSynjardy, Jardiamet
AHFS/Drugs.comProfessional Drug Facts
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
  • 864070-44-0 Y
  • 657-24-9 Y
PubChem CID
UNII
KEGG
ChEBI
Chemical and physical data
FormulaC27H39Cl2N5O7
Molar mass616.54 g·mol−1
3D model (JSmol)
  • CN(C)C(=N)N=C(N)N.COC1C(C(C(C(O1)C2=CC(=C(C=C2)Cl)CC3=CC=C(C=C3)OC4CCOC4)O)O)O.Cl
  • InChI=1S/C23H27ClO7.C4H11N5.ClH/c1-28-23-21(27)19(25)20(26)22(31-23)14-4-7-18(24)15(11-14)10-13-2-5-16(6-3-13)30-17-8-9-29-12-17;1-9(2)4(7)8-3(5)6;/h2-7,11,17,19-23,25-27H,8-10,12H2,1H3;1-2H3,(H5,5,6,7,8);1H/t17-,19+,20+,21-,22-,23-;;/m0../s1
  • Key:YBRWIMHXUHRVDV-ZBYKXHQASA-N

The most common side effects include hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or insulin, infections of the urinary tract and genitals, and increased urination.[5]

It was approved for use in the European Union in May 2015,[5] for use in the United States in August 2015,[6] and for use in Australia in May 2020.[2]

Medical uses

In the European Union empagliflozin/metformin is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control:[5]

  • in adults inadequately controlled on their maximally tolerated dose of metformin alone;[5]
  • in adults inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin;[5]
  • in adults already being treated with the combination of empagliflozin and metformin as separate tablets.[5]

In the United States it is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.[4]

Society and culture

Empagliflozin/metformin was approved for use in the European Union in May 2015.[5]

Empagliflozin/metformin was approved for use in the United States in August 2015.[6][7] The extended release version was approved for use in the United States in December 2016.[8][9]

Empagliflozin/metformin was approved for use in Australia in May 2020.[2]

References
  1. "Empagliflozin / metformin Use During Pregnancy". Drugs.com. 10 September 2019. Retrieved 11 February 2020.
  2. "Summary for ARTG Entry: 229815 Jardiamet 5 mg / 500 mg empagliflozin/metformin hydrochloride 5mg/500mg film coated tablet blister pack". Therapeutic Goods Administration (TGA).
  3. "Synjardy film coated tablets - Summary of Product Characteristics (SmPC)". (emc). 23 October 2019. Retrieved 10 February 2020.
  4. "Synjardy XR- empagliflozin, metformin hydrochloride tablet, extended release". DailyMed.
  5. "Synjardy EPAR". European Medicines Agency (EMA). Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. "Synjardy (empagliflozin and metformin hydrochloride) Tablets". U.S. Food and Drug Administration (FDA). 4 August 2016. Retrieved 10 February 2020.
  7. "Synjardy: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 10 February 2020.
  8. "Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets". U.S. Food and Drug Administration (FDA). 26 October 2017. Retrieved 10 February 2020.
  9. "Synjardy XR: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 11 February 2020.


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