Roswin Dosage/Direction for Use

Before initiating treatment with rosuvastatin, the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose of rosuvastatin should be individualized according to the goal of therapy and patient response, using current consensus guidelines.
The recommended start dose is 5 or 10 mg once daily in both statin naive patients or patients switched from another HMG-CoA reductase inhibitor. The choice of starting dose should take into account the individual patients cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. A dose adjustment to the next dose level can be made after 4 weeks, if necessary. In light of the increased of adverse reactions with the 40 mg dose compare to lower dose, a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolemia at high cardiovascular risk (in particular those with familial hypercholesterolemia) who do not achieve their treatment goal on 20 mg, and in whom routine follow up will be performed. Specialist supervision is recommended when the 40 mg dose is initiated.
Rosuvastatin may be given at any time of day, with or without food.
Use in Children: Safety and efficacy have not been established in children. Pediatric experience is limited to a small number of children (aged 8 years or above) with homozygous familial hypercholesterolemia. Therefore, rosuvastatin is not recommended for pediatric use at this time.
Use in the Elderly: A start dose of 5 mg is recommended in patients > 70 years. No other dose adjustment is necessary in relation to age.
Dosage in Patients with Renal Insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment.
For patients with severe renal impairment (CrCl < 30 mL/min/1.73m²) not on hemodialysis, dosing of rosuvastatin should be started at 5 mg once daily and not to exceeded 10 mg once daily.
Dosage in Patients with Hepatic Impairment: There was no increase in systemic exposure to rosuvastatin in patients with Child-Pugh scores of 7 or below. However, increased systemic exposure to rosuvastatin has been observed in patients with Child-Pugh scores of 8 and 9.
In these patients an assessment of renal function should be considered, therefore the dose of rosuvastatin should not exceed 20 mg once daily. There is no data in patients with Child-Pugh scores above 9.
Race: The increase of plasma concentration of rosuvastatin occured in Asian. Initiation of therapy with 5 mg once daily should be considered for Asian patients. The increased systemic exposure should be taken into consideration when treating Asian patients particularly in these whose hypercholesterolemia is not adequately controlled a doses up to 20 mg/daily.
Dosage in Patients with Pre-disposing Factors to Myopathy: The recommended start dose is 5 mg in patients with predisposing factors to myopathy.
Interactions requiring dose adjustment: Gemfibrozil: The concomitant use of rosuvastatin and gemfibrozil will increase systematic exposure of rosuvastatin (see PRECAUTIONS and INTERACTIONS).