Sitagliptindrug info
sitagliptin phosphate 100 MG Oral Tablet
What it is used for
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin. Sitagliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use: Sitagliptin tablets should not be used in patients with type 1 diabetes Sitagliptin has not been studied in patients with a history of pancreatitis.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 12, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[( R )-3-Amino-4-(2,4,5- trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3- a ]pyrazine monophosphate monohydrate. The empirical formula is C 16 H 15 F 6 N 5 O
H 3 PO 4
H 2 O and the molecular weight is 523.32. The structural formula is: Sitagliptin phosphate monohydrate is a white or almost white non-hygroscopic powder. It is soluble in water, very slightly soluble in anhydrous ethanol, and practically insoluble in heptane. Each film-coated tablet of sitagliptin contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, propyl gallate and talc. In addition, the film coating contains hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide. chemical-structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 12, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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