Generic name: ROSUVASTATIN CALCIUM 5mg
Dosage form: tablet, film coated
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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 (5.1)].
2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (8 to 17 years of age)
In patients 8 to less than 10 years of age with heterozygous familial hypercholesterolemia, the usual dose range is 5 to 10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population.
In patients 10 to 17 years of age with heterozygous familial hypercholesterolemia, the usual dose range is 5 to 20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Doses should be individualized according to the recommended goal of therapy [see Clinical Pharmacology (12) and Indications and Usage (1.1)]. Adjustments should be made at intervals of 4 weeks or more.
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 Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].
Use with Concomitant Therapy
Patients taking cyclosporine
Patients taking gemfibrozil
Patients taking atazanavir and ritonavir, lopinavir and ritonavir or simeprevir