DOSAGE AND ADMINISTRATION
General Dosing Information
The dose range for CRESTOR is 5 to 40 mg orally once daily. The usual starting dose is 10‑20 mg.
CRESTOR can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole.
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.
After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.
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
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)
The usual dose range of CRESTOR is 5‑20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see and ]. Adjustments should be made at intervals of 4 weeks or more.
Clinical Pharmacology
Indications and Usage
Homozygous Familial Hypercholesterolemia
The recommended starting dose of CRESTOR is 20 mg once daily. Response to therapy should be estimated from preapheresis LDL‑C levels.
Dosing in Asian Patients
In Asian patients, consider initiation of CRESTOR therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day. [see and ].
Use in Specific Populations
Clinical Pharmacology
Use with Concomitant Therapy
Patients taking cyclosporine
The dose of CRESTOR should not exceed 5 mg once daily [see, , and ].
Warnings and Precautions
Drug Interactions
Clinical Pharmacology
Patients taking gemfibrozil
Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [see and, and ].
Warnings and Precautions
Drug Interactions
Clinical Pharmacology
Patients taking lopinavir and ritonavir or atazanavir and ritonavir
Initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily [see, and ].
Warnings and Precautions
Drug Interactions
Clinical Pharmacology
Dosing in Patients with Severe Renal Impairment
For patients with severe renal impairment (CL <30 mL/min/1.73 m) not on hemodialysis, dosing of CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily [see and ].
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Use in Specific Populations
Clinical Pharmacology
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.
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