y.
Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) Do not exceed 10/20 mg LIPTRUZET daily.
HIV protease inhibitor (nelfinavir), hepatitis C protease inhibitor (boceprevir) Do not exceed 10/40 mg LIPTRUZET daily.
Other lipid-lowering medications: Use with fenofibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with LIPTRUZET. (7)
Fenofibrates: Combination increases exposure of ezetimibe. If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. (7.5, 12.3)
Cholestyramine: Combination decreases exposure of ezetimibe. (2.3, 12.3)
Digoxin: Patients should be monitored appropriately. (7.7)
Oral contraceptives: Values for norethindrone and ethinyl estradiol may be increased. (7.8)
Rifampin should be simultaneously coadministered with LIPTRUZET. (7.9)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Plasma concentrations of atorvastatin are markedly increased in patients with chronic alcoholic liver disease. (8.6, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Primary Hyperlipidemia 1.2 Homozygous Familial Hypercholesterolemia (HoFH) 1.3 Limitations of Use 2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing 2.2 Patients with Homozygous Familial Hypercholesterolemia 2.3 Coadministration with Other Drugs 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Myopathy/Rhabdomyolysis 5.2 Liver Enzymes 5.3 Endocrine Function 5.4 Use in Patients with Recent Stroke or TIA 5.5 CNS Toxicity 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS
7.1 Strong Inhibitors of Cytochrome P450 3A4 7.2 Cyclosporine 7.3 Grapefruit Juice 7.4 Gemfibrozil 7.5 Fenofibrates (e.g., fenofibrate and fenofibric acid) 7.6 Niacin 7.7 Digoxin 7.8 Oral Contraceptives 7.9 Rifampin or Other Inducers of Cytochrome P450 3A4 7.10 Colchicine 7.11 Cholestyramine 7.12 Coumarin Anticoagulants 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES
14.1 Primary Hyperlipidemia 14.2 Homozygous Familial Hypercholesterolemia (HoFH) 16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Muscle Pain 17.2 Liver Enzymes 17.3 Pregnancy 17.4 Breast-Feeding 17.5 Important Storage and Administration Instructions * Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the respon |
