DOSAGE AND ADMINISTRATION
General Dosing Information
The dose range for CRESTOR is 5 to 40 mg orally once daily.
CRESTOR can be administered as a single dose at any time of day, with or without food.
When initiating CRESTOR therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient's response and individualized goal of therapy.
The 40 mg dose of CRESTOR should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [ see Warnings and Precautions ].
2.2 Hyperlipidemia, Mixed Dyslipidemia, Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia), and Slowing of the Progression of Atherosclerosis
The recommended starting dose of CRESTOR is 10 mg once daily. For patients with marked hyperlipidemia (LDL-C > 190 mg/dL) and aggressive lipid targets, a 20 mg starting dose may be considered.
After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.
Homozygous Familial Hypercholesterolemia
The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from pre-apheresis LDL-C levels.
Dosage in Asian Patients
Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients. [ see Use in Specific Populations (8.8) and Clinical Pharmacology ].
Use with Cyclosporine, or Lopinavir/Ritonavir
In patients taking cyclosporine, the dose of CRESTOR should be limited to 5 mg once daily [ see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. In patients taking a combination of lopinavir and ritonavir the dose of CRESTOR should be limited to 10 mg once daily [ see Warnings and Precautions (5.1) and Drug Interactions (7.3)].
Concomitant Lipid-Lowering Therapy
The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with niacin or fenofibrate; a reduction in CRESTOR dosage should be considered in this setting. [ see Warnings and Precuations (5.1) and see Drug Interactions (7.5, 7.6)]
Combination therapy with gemfibrozil should be avoided because of an increase in CRESTOR exposure with concomitant use; if CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10 mg once daily [ see Warnings and Precautions (5.1) and Drug Interactions ].
Dosage in Patients With Severe Renal Impairment
For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily [ see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
DOSAGE FORMS AND STRENGTHS
5 mg: Yellow, round, biconvex, coated tablets. Debossed "CRESTOR" and "5" on one side of the tablet.
10 mg: Pink, round, biconvex, coated tablets. Debossed "CRESTOR" and "10" on one side of the tablet.
20 mg: Pink, round, biconvex, coated tablets. Debossed "CRESTOR" and "20" on one side of the tablet.
40 mg: Pink, oval, biconvex, coated tablets. Debossed "CRESTOR" on one side and "40" on the other side of the tablet.