Sitagliptindrug info

sitagliptin 50 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 is not recommended in patients with type 1 diabetes mellitus. Sitagliptin Tablets have 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 Tablets.. 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 are not recommended in patients with type 1 diabetes mellitus. Sitagliptin Tablets 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 January 31, 2025. 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 contain sitagliptin free base, an orally active inhibitor of the DPP-4 enzyme. Sitagliptin free base is described chemically as 7-[(3 R )-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3- a ]pyrazine. The empirical formula is C 16 H 15 F 6 N 5 O and the molecular weight is 407.31.

The structural formula is: Sitagliptin free base is a white to off-white, non-hygroscopic powder. Sitagliptin free base is soluble in methanol and slightly soluble in water. Each film coated tablet of sitagliptin contains sitagliptin free base 25 mg, 50 mg, or 100 mg as active ingredient and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow. Image

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 31, 2025. 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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