Dapagliflozin/metformin

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.^[4][5] It is a combination of dapagliflozin and metformin^[4] and is taken by mouth.^[4] Dapagliflozin/metformin was approved for use in the European Union in January 2014,^[3] in the United States in February 2014,^[5][6] and in Australia in July 2014.^[7]

Dapagliflozin/metformin

Combination of
Dapagliflozin	SGLT2 inhibitor
Metformin	Anti-diabetic biguanide
Clinical data
Trade names	Xigduo, Xigduo Xr, Ebymect
AHFS/Drugs.com	Professional Drug Facts
License data	US DailyMed: Xigduo Xr
Routes of administration	By mouth
ATC code	A10BD15 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only[1] UK: POM (Prescription only)[2] US: ℞-only EU: Rx-only[3] In general: ℞ (Prescription only)
Identifiers
CAS Number	2446159-54-0 Y
PubChem CID	85470863
KEGG	D10586
Chemical and physical data
Formula	C25H37Cl2N5O6
Molar mass	574.50 g·mol−1
3D model (JSmol)	Interactive image
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
InChI InChI=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 Key:IPQABJMJAWNGON-RFSZPCNPSA-N

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.^[8]

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

References

1. "Product monograph brand safety updates". Health Canada. February 2024. Archived from the original on 29 March 2024. Retrieved 24 March 2024.
2. "Xigduo Summary of Product Characteristics (SmPC)". (emc). 2 January 2020. Archived from the original on 20 February 2020. Retrieved 19 February 2020.
3. "Xigduo EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 12 July 2019. Retrieved 19 February 2020.
4. "Xigduo Xr- dapagliflozin and metformin hydrochloride tablet, film coated, extended release". DailyMed. 3 February 2020. Archived from the original on 2 March 2021. Retrieved 19 February 2020.
5. "Xigduo Xr (dapagliflozin and metformin HCl) Extended-Release Tablets". U.S. Food and Drug Administration (FDA). 7 April 2015. Archived from the original on 20 February 2020. Retrieved 19 February 2020.
6. "Xigduo Xr: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 19 February 2020.
7. "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. Archived from the original on 8 November 2023. Retrieved 6 July 2024.
8. "FDA revises labels of SGLT2 inhibitors for diabetes to include warning". U.S. Food and Drug Administration. 19 March 2020. Archived from the original on 7 June 2020. Retrieved 6 June 2020. This article incorporates text from this source, which is in the public domain.
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. Archived from the original on 27 June 2023. Retrieved 27 June 2023.
10. "Product Information safety updates - November 2022". Therapeutic Goods Administration (TGA). November 2022. Archived from the original on 27 June 2023. Retrieved 27 June 2023.