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The usual dose range is 10-40 mg orally once a day.
The dosage of Rosuvastatin (ROSUKON-20) should be individualised according to the goal of therapy and patient response. The majority of patients are controlled at the start dose. However, if necessary, dose adjustment can be made at 2 to 4 week intervals.
Rosuvastatin (ROSUKON-20) may be given at any time of day, with or without food.
Adults: Primary Hypercholesterolaemia (including Heterozygous Familial Hypercholesterolaemia), Mixed Dyslipidaemia, Dysbetalipoproteinaemia, Isolated Hypertriglyceridaemia and Treatment of Atherosclerosis and Prevention of Cardiovascular Events: The usual start dose is 10 mg once a day. A 5 mg start dose is available for special patient populations if needed.
For patients with severe hypercholesterolaemia (including heterozygous familial hypercholesterolaemia) or those with aggressive lipid targets, a start dose of 20 mg may be considered.
Homozygous Familial Hypercholesterolaemia: For patients with homozygous familial hypercholesterolaemia a start dose of 20 mg once a day is recommended.
Children and Adolescents 6 to 17 Years of Age: 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.
The dose should be appropriately titrated to achieve treatment goal. In children and adolescents with homozygous familial hypercholesterolaemia experience is limited to a small number of patients (aged 8 years and above).
Special Populations: Use in the Elderly: The usual dose range applies.
Dosage in Patients with Renal Insufficiency: The usual dose range applies in patients with mild to moderate renal impairment.
For patients with severe renal impairment the dose of Rosuvastatin (ROSUKON-20) should not exceed 10 mg once daily. (See Pharmacology: Pharmacokinetics under Actions.)
Dosage in Patients with Hepatic Insufficiency: The usual dose range applies in patients with mild to moderate hepatic impairment.
Increased systemic exposure to rosuvastatin has been observed in patients with severe hepatic impairment, therefore the use of doses above Rosuvastatin (ROSUKON-20) 10 mg should be carefully considered. (See Pharmacology: Pharmacokinetics under Actions.)
Race: A 5 mg starting dose of Rosuvastatin (ROSUKON-20) should be considered for Asian patients. Increased plasma concentration of rosuvastatin has been seen in Asian subjects (see Precautions and Pharmacology: Pharmacokinetics under Actions). The increased systemic exposure should be taken into consideration when treating Asian patients whose hypercholesterolaemia is not adequately controlled at doses up to 20 mg/day.
Genetic Polymorphisms: Genotypes of SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA have been shown to be associated with an increase in rosuvastatin exposure (AUC) compared to SLCO1B1 c.521TT and ABCG2 c.421CC. For patients known to have the c.521CC or c.421AA genotype, a maximum once daily dose of 20 mg of Rosuvastatin (ROSUKON-20) is recommended (see Precautions, Interactions and Pharmacology: Pharmacokinetics under Actions).
Concomitant Therapy: Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Rosuvastatin (ROSUKON-20) is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir; see Precautions and Interactions). It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rosuvastatin (ROSUKON-20). Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing Rosuvastatin (ROSUKON-20) therapy. In situations where co-administration of these medicinal products with Rosuvastatin (ROSUKON-20) is unavoidable, the benefit and the risk of concurrent treatment and Rosuvastatin (ROSUKON-20) dosing adjustments should be carefully considered (see Interactions).
