Dapagliflozin/metformin explained

Type:combo
Component1:Dapagliflozin
Class1:SGLT2 inhibitor
Component2:Metformin
Class2:Anti-diabetic biguanide
Tradename:Xigduo, Xigduo Xr, Ebymect
Dailymedid:Xigduo Xr
Routes Of Administration:By mouth
Atc Prefix:A10
Atc Suffix:BD15
Legal Au:S4
Legal Ca:Rx-only
Legal Ca Comment:[1]
Legal Uk:POM
Legal Uk Comment:[2]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:2446159-54-0
Pubchem:85470863
Kegg:D10586
C:25
H:37
Cl:2
N:5
O:6
Smiles:CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C3C(C(C(C(O3)CO)O)O)O)Cl.CN(C)C(=N)N=C(N)N.Cl
Stdinchi:1S/C21H25ClO6.C4H11N5.ClH/c1-2-27-15-6-3-12(4-7-15)9-14-10-13(5-8-16(14)22)21-20(26)19(25)18(24)17(11-23)28-21;1-9(2)4(7)8-3(5)6;/h3-8,10,17-21,23-26H,2,9,11H2,1H3;1-2H3,(H5,5,6,7,8);1H/t17-,18-,19+,20-,21?;;/m1../s1
Stdinchikey:IPQABJMJAWNGON-RFSZPCNPSA-N

Dapagliflozin/metformin, sold under the brand name Xigduo Xr among others, is a fixed-dose combination anti-diabetic medication used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.[3] It is a combination of dapagliflozin and metformin and is taken by mouth. Dapagliflozin/metformin was approved for use in the European Union in January 2014,[4] in the United States in February 2014,[5] [6] and in Australia in July 2014.[7]

Adverse effects

To lessen the risk of developing ketoacidosis (a serious condition in which the body produces high levels of blood acids called ketones) after surgery, the FDA has approved changes to the prescribing information for SGLT2 inhibitor diabetes medicines to recommend they be stopped temporarily before scheduled surgery. Canagliflozin, dapagliflozin, and empagliflozin should each be stopped at least three days before, and ertugliflozin should be stopped at least four days before scheduled surgery.[8]

Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.

A potential interaction between dapagliflozin and lithium concomitant causing a reduction in serum lithium levels was bulletined in 2022.[9] [10]

Notes and References

  1. Web site: Product monograph brand safety updates . Health Canada . February 2024 . 24 March 2024 . 29 March 2024 . https://web.archive.org/web/20240329200203/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/label-safety-assessment-update/product-monograph-brand-safety-updates.html . live .
  2. Web site: Xigduo Summary of Product Characteristics (SmPC) . (emc) . 2 January 2020 . 19 February 2020 . 20 February 2020 . https://web.archive.org/web/20200220075603/https://www.medicines.org.uk/emc/product/5293/smpc . live .
  3. Web site: 3 February 2020 . Xigduo Xr- dapagliflozin and metformin hydrochloride tablet, film coated, extended release . 19 February 2020 . DailyMed . 2 March 2021 . https://web.archive.org/web/20210302075051/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859 . live .
  4. Web site: Xigduo EPAR . European Medicines Agency (EMA) . 17 September 2018 . 19 February 2020 . 12 July 2019 . https://web.archive.org/web/20190712100819/https://www.ema.europa.eu/en/medicines/human/EPAR/xigduo . live .
  5. Web site: Xigduo Xr (dapagliflozin and metformin HCl) Extended-Release Tablets . U.S. Food and Drug Administration (FDA) . 7 April 2015 . 19 February 2020 . 20 February 2020 . https://web.archive.org/web/20200220075559/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000TOC.cfm . live .
  6. Web site: Xigduo Xr: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 19 February 2020.
  7. Web site: Xigduo Xr 5/1000 dapagliflozin 5 mg (as propanediol monohydrate) / metformin hydrochloride 1000 mg modified release tablets blister pack (211296) . Therapeutic Goods Administration (TGA) . 27 May 2022 . 6 July 2024 . 8 November 2023 . https://web.archive.org/web/20231108173257/https://www.tga.gov.au/resources/artg/211296 . live .
  8. Web site: FDA revises labels of SGLT2 inhibitors for diabetes to include warning . U.S. Food and Drug Administration . 19 March 2020 . 6 June 2020 . 7 June 2020 . https://web.archive.org/web/20200607011955/https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-labels-sglt2-inhibitors-diabetes-include-warnings-about-too-much-acid-blood-and-serious . live .
  9. Research . Center for Drug Evaluation and . 8 July 2022 . January - March 2022 Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) . FDA . en . 27 June 2023 . 27 June 2023 . https://web.archive.org/web/20230627132059/https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/january-march-2022-potential-signals-serious-risksnew-safety-information-identified-fda-adverse . live .
  10. Web site: November 2022 . Product Information safety updates - November 2022 . 27 June 2023 . Therapeutic Goods Administration (TGA) . 27 June 2023 . https://web.archive.org/web/20230627132101/https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-november-2022 . live .

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Dapagliflozin/metformin".

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