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Sitagliptin/metformin

From Wikipedia, the free encyclopedia
Pharmaceutical drug

Pharmaceutical compound
Sitagliptin/metformin
Combination of
SitagliptinDipeptidyl peptidase-4 inhibitor
MetforminBiguanide
Clinical data
Trade namesJanumet, Januet, others
AHFS/Drugs.comProfessional Drug Facts
License data
Pregnancy
category
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Identifiers
KEGG

Sitagliptin/metformin, sold under the brand nameJanumet among others, is afixed-dose combinationanti-diabetic medication used to treattype 2 diabetes.[10] It may be used in those whose blood sugar is not controlled withmetformin and asulfonylurea.[10][11] It is takenby mouth.[10]

Common side effects include diarrhea, headache, and upper respiratory tract infections.[5] Serious side effects may includelactic acidosis,pancreatitis,low blood sugar,heart failure, joint pain, andallergic reactions.[5] It has not been properly studied in women who arepregnant orbreastfeeding.[1] It containssitagliptin (adipeptidyl peptidase-4 inhibitor) andmetformin (abiguanide).[5]

The combination was approved for medical use in the United States in 2007.[5] In 2022, it was the 182nd most commonly prescribed medication in the United States, with more than 2 million prescriptions.[12][13] It is available as a generic medication.[14][15]

Medical uses

[edit]

In the United States, sitagliptin/metformin isindicated as an adjunct to diet and exercise to improveglycemic control in adults withtype 2 diabetes.[5][6]

In the European Union, sitagliptin/metformin is indicated as an adjunct to diet and exercise to improve glycemic control in people with type 2 diabetes; in combination with asulfonylurea as an adjunct to diet and exercise "in people inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea; as triple combination therapy with aperoxisome proliferator-activated receptor (PPAR) agonist (i.e., athiazolidinedione) as an adjunct to diet and exercise in people inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist; and as add-on toinsulin as an adjunct to diet and exercise to improve glycemic control in people when stable dosage of insulin and metformin alone do not provide adequate glycemic control."[7]

In December 2020, the U.S.Food and Drug Administration (FDA) approved labeling changes stating that Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin hydrochloride extended-release) are not proven to improve glycemic (blood sugar) control in children aged 10 to 17 with type 2 diabetes.[16] The drugs are approved to improve blood sugar control in adults aged 18 and older with type 2 diabetes.[16]

Society and culture

[edit]

Brand names

[edit]

As of 2018, the combination is marketed under several brand names, including Efficib,[8] Janmet, Januet, Janumet, Jznumet, Ristaben Met, Ristfor, Siglimet, Sitamet, Sitar-M, Sliptin-M, Treviamet, Velmetia, Istamet, Emsita, Sitaglyn, Sitazit-M, and Zaxoran.[17]

References

[edit]
  1. ^ab"Metformin / sitagliptin Use During Pregnancy".Drugs.com.Archived from the original on 19 April 2019. Retrieved19 April 2019.
  2. ^"Sitagliptin/metformin Sandoz XR (Sandoz Pty Ltd)".Therapeutic Goods Administration (TGA). 2 June 2023. Retrieved10 September 2023.
  3. ^"Product monograph brand safety updates".Health Canada. February 2024. Retrieved24 March 2024.
  4. ^"Janumet 50 mg/1000 mg film-coated tablets - Summary of Product Characteristics (SmPC)".(emc). 25 November 2020.Archived from the original on 26 October 2020. Retrieved5 December 2020.
  5. ^abcdef"Janumet- sitagliptin and metformin hydrochloride tablet, film coated".DailyMed. 12 August 2019.Archived from the original on 9 June 2021. Retrieved5 December 2020.
  6. ^ab"Janumet XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release".DailyMed.Archived from the original on 29 October 2020. Retrieved5 December 2020.
  7. ^ab"Janumet EPAR".European Medicines Agency (EMA). 9 December 2009.Archived from the original on 9 June 2021. Retrieved5 December 2020.
  8. ^ab"Efficib EPAR".European Medicines Agency. 16 July 2008. Retrieved25 July 2024.
  9. ^"Velmetia EPAR".European Medicines Agency (EMA). 16 July 2008. Retrieved19 October 2024.
  10. ^abcBritish national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 682.ISBN 9780857113382.
  11. ^Hayes J, Anderson R, Stephens JW (2016)."Sitagliptin/metformin fixed-dose combination in type 2 diabetes mellitus: an evidence-based review of its place in therapy".Drug Design, Development and Therapy.10:2263–70.doi:10.2147/DDDT.S93076.PMC 4958358.PMID 27486305.
  12. ^"The Top 300 of 2022".ClinCalc.Archived from the original on 30 August 2024. Retrieved30 August 2024.
  13. ^"Metformin; Sitagliptin Drug Usage Statistics, United States, 2013 - 2022".ClinCalc. Retrieved30 August 2024.
  14. ^"Sitagliptin / Metformin hydrochloride Accord EPAR".European Medicines Agency (EMA). 17 May 2022.Archived from the original on 3 August 2022. Retrieved3 August 2022.
  15. ^"Sitagliptin / Metformin hydrochloride Sun: Pending EC decision".European Medicines Agency (EMA). 26 January 2023.Archived from the original on 27 January 2023. Retrieved28 January 2023.
  16. ^ab"New studies show diabetes drug not proven to improve blood sugar control in pediatric patients".U.S. Food and Drug Administration. 4 December 2020. Archived fromthe original on 4 December 2020. Retrieved5 December 2020.Public Domain This article incorporates text from this source, which is in thepublic domain.
  17. ^"International brands for Sitagliptin/metformin". Drugs.com.Archived from the original on 23 August 2019. Retrieved3 September 2018.
Oraldiabetes medication,insulins andinsulin analogues, and other drugs used in diabetes (A10)
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Aldose reductase inhibitors
Alpha-glucosidase inhibitors
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