7.3 Grapefruit JuiceGrapefruit juice contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of atorvastatin, especially with excessive grapefruit juice consumption (>1.2 liters per day).

7.4 GemfibrozilDue to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of LIPTRUZET with gemfibrozil should be avoided [see Warnings and Precautions (5.1)].

7.5 Fenofibrates (e.g., fenofibrate and fenofibric acid)Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of fenofibrates, LIPTRUZET should be administered with caution when used concomitantly with a fenofibrate [see Warnings and Precautions (5.1)].

Fenofibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected in a patient receiving LIPTRUZET and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered [see the product labeling for fenofibrate and fenofibric acid].

7.6 NiacinThe risk of skeletal muscle effects may be enhanced when LIPTRUZET is used in combination with niacin; a reduction in LIPTRUZET dosage should be considered in this setting [see Warnings and Precautions (5.1)].

7.7 DigoxinWhen multiple doses of atorvastatin and digoxin were coadministered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.

7.8 Oral ContraceptivesCoadministration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol [see Clinical Pharmacology (12.3)]. These increases should be considered when selecting an oral contraceptive for a woman taking LIPTRUZET.

7.9 Rifampin or Other Inducers of Cytochrome P450 3A4Concomitant administration of atorvastatin with inducers of cytochrome P450 3A4 (e.g., efavirenz, rifampin) can lead to variable reductions in plasma concentrations of atorvastatin. Due to the dual interaction mechanism of rifampin, simultaneous coadministration of LIPTRUZET with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations.

7.10 ColchicineCases of myopathy, including rhabdomyolysis, have been reported with atorvastatin coadministered with colchicine, and caution should be exercised when prescribing LIPTRUZET with colchicine.

7.11 CholestyramineConcomitant cholestyramine administration decreased the mean area under the curve (AUC) of total ezetimibe approximately 55%. The incremental LDL-C reduction due to adding ezetimibe to cholestyramine may be reduced by this interaction.
7.12 Coumarin AnticoagulantsIf LIPTRUZET is added to warfarin, a coumarin anticoagulant, the International Normalized Ratio (INR) should be appropriately monitored.

8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category X.

[See Contraindications (4).]

LIPTRUZET

LIPTRUZET is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy. Lipid-lowering drugs offer no benefit during pregnancy, because cho