Source: FDA, National Drug Code (US) Revision Year: 2022
VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor.
The chemical name of ezetimibe is 1-(4-fluorophenyl)3==®==[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.
Its structural formula is:
Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor 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-[1α,3α,7β,8β(2S,4S),-8aβ]]. 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 in water and freely soluble in chloroform, methanol and ethanol.
Its structural formula is:
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), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.
Dosage Forms and Strengths |
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How Supplied |
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VYTORIN 10/10 are white to off-white capsule-shaped tablets with code “311” on one They are supplied as follows: NDC 78206-174-01 bottles of 30 VYTORIN 10/20 are white to off-white capsule-shaped tablets with code “312” on one They are supplied as follows: NDC 78206-175-01 bottles of 30 VYTORIN 10/40 are white to off-white capsule-shaped tablets with code “313” on one side. They are supplied as follows: NDC 78206-176-01 bottles of 30 VYTORIN 10/80 are white to off-white capsule-shaped tablets with code “315” on one They are supplied as follows: NDC 78206-177-01 bottles of 30 Distributed by: Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA |
Drug | Countries | |
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VYTORIN | Australia, Brazil, Germany, Ecuador, Spain, Hong Kong, Italy, Mexico, Singapore, United States |
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