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
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] In 2020, it was the 238th most commonly prescribed medication in the United States, with more than 1 million prescriptions.[7][8] It is available as a generic medication.[9]

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]

In June 2023, the US Food and Drug Administration (FDA) expanded the indication, as an addition to diet and exercise, to improve blood sugar control in children 10 years and older with type 2 diabetes.[10]

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][11] The extended release version was approved for use in the United States in December 2016.[12][13]

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). 17 September 2018. 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. "The Top 300 of 2020". ClinCalc. Retrieved 7 October 2022.
  8. "Empagliflozin; Metformin - Drug Usage Statistics". ClinCalc. Retrieved 7 October 2022.
  9. "2022 First Generic Drug Approvals". U.S. Food and Drug Administration (FDA). 3 March 2023. Archived from the original on 30 June 2023. Retrieved 30 June 2023.
  10. "FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes". U.S. Food and Drug Administration (FDA) (Press release). 20 June 2023. Retrieved 20 June 2023.
  11. "Synjardy: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 10 February 2020.
  12. "Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets". U.S. Food and Drug Administration (FDA). 26 October 2017. Retrieved 10 February 2020.
  13. "Synjardy XR: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 11 February 2020.


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