Rosuzet Description

Ezetimibe + Rosuvastatin (ROSUZET) is available for oral use as tablets containing 10.4 mg of rosuvastatin calcium, equivalent to 10 mg of rosuvastatin [Ezetimibe + Rosuvastatin (ROSUZET 10/10)]; 20.8 mg of rosuvastatin calcium, equivalent to 20 mg of rosuvastatin [Ezetimibe + Rosuvastatin (ROSUZET 10/20)].
Ezetimibe + Rosuvastatin (ROSUZET) contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and rosuvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor.
Ezetimibe: 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.
Rosuvastatin: Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is calcium bis[(3R,5S,6E)-7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate]. The empirical formula for rosuvastatin calcium is (C₂₂H₂₇FN₃O₆S)₂Ca. Its molecular weight is 1001.14.
Rosuvastatin calcium is a white or almost white powder that is soluble in methylene chloride. It is slightly soluble in water. Rosuvastatin calcium is a slightly hygroscopic compound with a partition coefficient (octanol/water) of 4.55 at pH of 3.82.
Excipients/Inactive Ingredients: Each tablet of Ezetimibe + Rosuvastatin (ROSUZET) contains the following inactive ingredients: lactose monohydrate, sodium lauryl sulfate, croscarmellose sodium, povidone, cellulose microcrystalline, crospovidone, magnesium stearate, and mannitol.
The film coating contains: hypromellose, polyethylene glycol 6000/macrogol 8000, talc, titanium oxide, iron oxide yellow and iron oxide red.