ombination of LIPTRUZET and gemfibrozil is not recommended [see Warnings and Precautions (5.1) and Drug Interactions (7.4)].
3 DOSAGE FORMS AND STRENGTHS
LIPTRUZET™ 10 mg/10 mg (ezetimibe 10 mg/atorvastatin 10 mg) tablets are white to off-white capsule-shaped, biconvex film-coated tablets with code "320" on one side.
LIPTRUZET™ 10 mg/20 mg (ezetimibe 10 mg/atorvastatin 20 mg) tablets are white to off-white round, biconvex film-coated tablets with code "321" on one side.
LIPTRUZET™ 10 mg/40 mg (ezetimibe 10 mg/atorvastatin 40 mg) tablets are white to off-white oval, biconvex film-coated tablets with code "322" on one side.
LIPTRUZET™ 10 mg/80 mg (ezetimibe 10 mg/atorvastatin 80 mg) tablets are white to off-white capsule-shaped, biconvex film-coated tablets with code "323" on one side.
4 CONTRAINDICATIONS
Active liver disease or unexplained persistent elevations of hepatic transaminase levels.
Hypersensitivity to any component of LIPTRUZET [see Adverse Reactions (6.2)].
Women who are pregnant or may become pregnant. LIPTRUZET may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of LIPTRUZET use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, atorvastatin revealed no evidence of teratogenicity. LIPTRUZET should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, LIPTRUZET should be discontinued immediately, and the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].
Nursing mothers. It is not known whether atorvastatin is excreted into human milk; however, a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require LIPTRUZET treatment should not breast-feed their infants [see Use in Specific Populations (8.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Myopathy/Rhabdomyolysis
Atorvastatin
Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin and with other drugs in this class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects.
Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times upper limit of normal (ULN). The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis.
There have been rare reports of immune-mediated necrotizing myopathy (IM |
