Atozet Description

ATOZET are bilayer, capsule shaped, biconvex, film coated tablets, white to off white in color and with the following size and debossing.
10 mg/20 mg: with "333" debossed on one side of the tablet.
10 mg/40 mg: with "337" debossed on one side of the tablet.
Active Ingredients: ATOZET is available for oral use as tablets containing 10 mg of ezetimibe and 21.7 mg of atorvastatin calcium (crystalline trihydrate), equivalent to 20 mg of atorvastatin (ATOZET 10 mg/20 mg); or 43.4 mg of atorvastatin calcium (crystalline trihydrate), equivalent to 40 mg of atorvastatin (ATOZET 10 mg/40 mg).
Chemistry: ATOZET 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.
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.
Atorvastatin: Atorvastatin is [R-(R^*, R^*)]-2-(4-fluorophenyl)-β, 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 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.
Excipients/Inactive Ingredients: Calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, and sodium lauryl sulfate.
The film coating contains: hydroxypropyl methylcellulose/hypromellose, macrogol/polyethylene glycol, titanium dioxide, and talc.