Rosmi Dosage/Direction for Use

Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualized according to the goal of therapy and patient response, using current consensus guideline.
The recommended start dose is 5 or 10 mg once daily in both statin naïve 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 20 mg can be made after 2 to 4 weeks, if necessary.
It may be given at any time of day, with or without food.
Children and adolescents 6 to 17 years of age: In children 6 to 9 years of age with heterozygous familial hypercholesterolemia, the usual dose range is 5 - 10 mg orally once daily. The dose greater than 10 mg has not been studied in efficacy and safety.
In children 10 to 17 years of age with heterozygous familial hypercholesterolemia, the usual dose range is 5 - 20 mg orally once daily. The dose greater than 20 mg has not been studied in efficacy and safety.
The dose should be appropriately titrated to achieve treatment goal.
Geriatric patients: No dose adjustment is necessary.
Race: The recommended start dose is 5 mg for patients of Asian ancestry. Increased plasma concentration of Rosuvastatin has been seen in Asian subjects. The increased systemic exposure should be taken into consideration when treating Asians particularly in those whose hypercholesterolemia is not adequately controlled at doses up to 20 mg/day.
Renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment. The use of Rosuvastatin in patients with severe renal impairment is contraindicated.
Hepatic impairment: There was no increase in systemic exposure to Rosuvastatin in subject with Child-Pugh scores of 7 or below. However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9. In these patients and assessment of renal function should be considered. There is no experience in subjects with Child-Pugh scores above 9. Rosuvastatin is contraindicated in patients with active liver disease.
ADMINISTRATION: Rosuvastatin is administered orally as a single dose at any time of day, with or without food.