Dipeptidyl Peptidase 4 Inhibitors

Dipeptidyl Peptidase 4 Inhibitor

Diabetes Mellitus, Type 2

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. </p><p>Sitagliptin phosphate monohydrate is described chemically as 7-[(3<span class="Italics">R</span>)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-<span class="Italics">a</span>]pyrazine phosphate (1:1) monohydrate.</p><p>The empirical formula is C<span class="Sub">16</span>H<span class="Sub">15</span>F<span class="Sub">6</span>N<span class="Sub">5</span>O•H<span class="Sub">3</span>PO<span class="Sub">4</span>•H<span class="Sub">2</span>O and the molecular weight is 523.32. The structural formula is: </p><table class="Noautorules" width="100%"><caption><span></span></caption><col align="center" valign="top" width="100%"/><tbody class="Headless"><tr><td align="center"><img alt="image of sitagliptin chemical structure" src="januvia-01.jpg"/></td></tr></tbody></table><p>Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.</p><p>Each film-coated tablet of JANUVIA 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: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</p></section>

JANUVIA

sitagliptin

Januvia

sitagliptin 100 MG Oral Tablet

sitagliptin 100 MG Oral Tablet [Januvia]

sitagliptin 25 MG Oral Tablet

sitagliptin 25 MG Oral Tablet [Januvia]

sitagliptin 50 MG Oral Tablet

sitagliptin 50 MG Oral Tablet [Januvia]

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