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(ezetimibe and atorvastatin) Tablets
LIPTRUZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, 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. 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:
Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate.
Atorvastatin calcium is a white or almost white crystalline powder that is soluble in dimethyl sulfoxide. The degree of solubility in water, ethanol, and methylene chloride is very slightly soluble to practically insoluble. The molecular formula of atorvastatin calcium is C66H68CaF2N4O10.3H2O. The molecular weight of atorvastatin calcium is 1209.36. Its structural formula is:
LIPTRUZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.9 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LIPTRUZET 10 mg/10 mg); 21.7 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LIPTRUZET 10 mg/20 mg); 43.4 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LIPTRUZET 10 mg/40 mg); or 86.8 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LIPTRUZET 10 mg/80 mg). Each film-coated tablet of LIPTRUZET contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate, hydroxypropyl cellulose, calcium carbonate, colloidal silicon dioxide, and polysorbate. In addition, the film coating contains the following inactive ingredients: hydroxypropyl methylcellulose/hypromellose, macrogol/polyethylene glycol, titanium dioxide, and talc.
Last reviewed on RxList: 5/29/2014
This monograph has been modified to include the generic and brand name in many instances.
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