Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines.
Dosage in adult patients with normal renal function: Treatment of hypercholesterolaemia: The recommended start dose is 5 or 10 mg orally once daily in both statin naive or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's 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 reporting rate of adverse reactions with the 40 mg dose compared to lower doses, a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), 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.
Prevention of cardiovascular events: In the cardiovascular events risk reduction study, the dose used was 20 mg daily.
Dosage in pediatric patients: Paediatric population: Paediatric use should only be carried out by specialists.
Children and adolescents 6 to 17 years of age (Tanner Stage <II-V): In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.
In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population.
In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Children younger than 6 years: The safety and efficacy of use in children younger than 6 years has not been studied. Therefore, Rosuvastatin is not recommended for use in children younger than 6 years.
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.
Administration Instructions: Rosuvastatin may be given at any time of day, with or without food.
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