Source: FDA, National Drug Code (US) Revision Year: 2019
NESINA tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4).
Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C18H21N5O2âĒC7H6O2 and a molecular weight of 461.51 daltons.
The structural formula is:
Alogliptin benzoate is a white to off-white crystalline powder containing one asymmetric carbon in the aminopiperidine moiety. It is soluble in dimethylsulfoxide, sparingly soluble in water and methanol, slightly soluble in ethanol and very slightly soluble in octanol and isopropyl acetate.
Each NESINA tablet contains 34 mg, 17 mg or 8.5 mg alogliptin benzoate, which is equivalent to 25 mg, 12.5 mg or 6.25 mg, respectively, of alogliptin and the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, ferric oxide (red or yellow) and polyethylene glycol, and is marked with printing ink (Gray F1).
Dosage Forms and Strengths |
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How Supplied | ||||||||||||||||
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NESINA tablets are available as film-coated tablets containing 25 mg, 12.5 mg or 6.25 mg of alogliptin as follows: 25 mg tablet: light red, oval, biconvex, film-coated, with “TAK ALG-25” printed on one side, available in:
12.5 mg tablet: yellow, oval, biconvex, film-coated, with “TAK ALG-12.5” printed on one side, available in:
6.25 mg tablet: light pink, oval, biconvex, film-coated, with “TAK ALG-6.25” printed on one side, available in:
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Drug | Countries | |
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NESINA | Australia, Brazil, Canada, Hong Kong, Japan, Singapore, United States |
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