Sitagliptin/metformin

Sitagliptin/metformin, sold under the brand name Janumet among others, is a fixed-dose combination anti-diabetic medication used to treat type 2 diabetes.[6] It may be used in those whose blood sugar is not controlled with metformin and a sulfonylurea.[6][7] It is taken by mouth.[6]

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
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only) [2]
  • US: ℞-only [3][4]
  • EU: Rx-only [5]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
UNII
KEGG

Common side effects include diarrhea, headache, and upper respiratory tract infections.[1] Serious side effects may include lactic acidosis, pancreatitis, low blood sugar, heart failure, joint pain, and allergic reactions.[1] It has not been properly studied in people who are pregnant or breastfeeding.[8] It contains sitagliptin (a dipeptidyl peptidase-4 inhibitor) and metformin (a biguanide).[1]

The combination was approved for medical use in the United States in 2007.[1] In 2017, it was the 139th most commonly prescribed medication in the United States, with more than four million prescriptions.[9][10]

Medical uses

In the United States, sitagliptin/metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.[3][4]

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 a sulfonylurea 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 a peroxisome proliferator-activated receptor (PPAR) agonist (i.e., a thiazolidinedione) 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 to insulin 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."[5]

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.[11] The drugs are approved to improve blood sugar control in adults aged 18 and older with type 2 diabetes.[11]

Society and culture

Brand names

As of 2018, the combination was marketed under several brand names, including Efficib, Janmet, Januet, Janumet, Jznumet, Ristaben Met, Ristfor, Siglimet, Sitamet, Sitar-M, Sliptin-M, Treviamet, and Velmetia.[12]

References
  1. "Janumet - FDA prescribing information, side effects and uses". Drugs.com. Retrieved 19 April 2019.
  2. "Janumet 50 mg/1000 mg film-coated tablets - Summary of Product Characteristics (SmPC)". (emc). 25 November 2020. Retrieved 5 December 2020.
  3. "Janumet- sitagliptin and metformin hydrochloride tablet, film coated". DailyMed. 12 August 2019. Retrieved 5 December 2020.
  4. "Janumet XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release". DailyMed. Retrieved 5 December 2020.
  5. "Janumet EPAR". European Medicines Agency (EMA). Retrieved 5 December 2020.
  6. British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 682. ISBN 9780857113382.
  7. 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.
  8. "Metformin / sitagliptin Use During Pregnancy". Drugs.com. Retrieved 19 April 2019.
  9. "The Top 300 of 2020". ClinCalc. Retrieved 11 April 2020.
  10. "Metformin Hydrochloride; Sitagliptin Phosphate - Drug Usage Statistics". ClinCalc. Retrieved 11 April 2020.
  11. "New studies show diabetes drug not proven to improve blood sugar control in pediatric patients". U.S. Food and Drug Administration. 4 December 2020. Retrieved 5 December 2020. This article incorporates text from this source, which is in the public domain.
  12. "International brands for Sitagliptin/metformin". Drugs.com. Retrieved 3 September 2018.
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