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
  • AU: D [1]
  • US: N (Not classified yet) [1]
    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)

    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]

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    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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