Zyrova Dosage/Direction for Use

5 mg: The usual initial dose of Rosuvastatin is 5 mg or 10 mg once daily, depending on plasma-cholesterol concentrations, cardiovascular risk factors for adverse effects. The maintenance dose ranges from 5 mg to 40 mg once daily although the 40 mg dose is reserved for patients with high cardiovascular risk who do not achieved their target cholesterol concentration at lower doses and who do not have risk factors for adverse effects. Specific dosage recommendations vary; for dosage in renal impairment.
10 mg & 20 mg: The patient should be placed on a standard cholesterol-lowering diet before receiving rosuvastatin and should continue on this diet during treatment with Zyrova. Rosuvastatin may be given as a single dose at any time of the day, with or without food. The dose of rosuvastatin should be individualized according to the goal of therapy and patient response.
Usual Recommended Dose: Starting Dosage: 10 mg once daily.
Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy.
Marked Hypercholesterolemia (LDL-C >190 mg/dL) and Aggressive Targets: Starting Dose: 20 mg. The 40-mg dose should be reserved for those patients who have not achieved goal LDL-C at 20 mg. After initiation and/or upon titration of rosuvastatin, lipid levels should be analyzed within 2-4 weeks and dosage adjusted accordingly.
Renal Impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment. For patients with severe renal impairment (CrCl <30 mL/min/m²) not on hemodialysis, dosing of rosuvastatin should be started at 5 mg once daily and not to exceed 10 mg once daily.
In patients taking cyclosporine therapy, therapy should be limited to 5 mg once daily. If rosuvastatin is used in combination with gemfibrozil, the dose should be limited to 10 mg once daily.
40 mg: General Dosing Information: The dose range for Rosuvastatin is 5 to 40 mg orally once daily. The usual starting dose is 10 - 20 mg. Rosuvastatin can be administered as a single dose at any time time of day, with or without food. When initiating Rosuvastatin therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosuvastain 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 Rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.
The 40 mg dose of Rosuvastatin should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age): The usual dose range of Rosuvastatin 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. Adjustments should be made at intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolemia: The recommended starting dose of Rosuvastatin 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 Rosuvastatin 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.
Use with Concomitant Therapy: Patients taking cyclosporine: The dose of Rosuvastatin should not exceed 5 mg once daily.
Patients taking gemfibrozil: Initiate Rosuvastatin therapy with 5 mg once daily. The dose of Rosuvastatin should not exceed 10 mg once daily.
Patients taking lopinavir and ritonavir or atazanavir and ritonavir: Initiate Rosuvastatin therapy with 5 mg once daily. The dose of Rosuvastatin should not exceed 10 mg once daily.
Dosing in Patients with Severe Renal Impairment: For patients with severe renal impairment (Clcr <30 mL/min/1.73m²) not on hemodialysis, dosing of Rosuvastatin should be started at 5 mg once daily and not exceed 10 mg once daily.