Vytorin

[ezetimibe/simvastatin]

Drug Description
DESCRIPTION

VYTORIN (ezetimibe/simvastatin)

VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterolabsorption, and simvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water.

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Simvastatin, an inactive lactone, is hydrolyzed to the corresponding ß-hydroxyacid form, which is aninhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1a,3a,7ß,8ß(2S*,4S*),-8aß]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble inwater, and freely soluble in chloroform, methanol and ethanol.

VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin(VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylatedhydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hydroxypropylmethylcellulose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF,and propyl gallate NF.

HOW SUPPLIED

VYTORIN TM 10/10
(EZETIMIBE 10 MG/SIMVASTATIN 10 MG TABLETS)
VYTORIN TM 10/20
(EZETIMIBE 10 MG/SIMVASTATIN 20 MG TABLETS)
VYTORIN TM 10/40
(EZETIMIBE 10 MG/SIMVASTATIN 40 MG TABLETS)
VYTORIN TM 10/80
(EZETIMIBE 10 MG/SIMVASTATIN 80 MG TABLETS)

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