Crestor 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 individualised according to the goal of therapy and patient response, using current consensus guidelines.
CRESTOR may be given at any time of day, with or without food.
The recommended start dose is 5 mg or 10 mg orally once daily in both statin naïve 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 (see Pharmacology: Pharmacodynamics under Actions). In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses (see Adverse Reactions), 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 (see Precautions). Specialist supervision is recommended when the 40 mg dose is initiated.
Use in children: Safety and efficacy have not been established in children. Paediatric experience is limited to a small number of children (aged 8 years or above) with homozygous familial hypercholesterolaemia. Therefore, CRESTOR is not recommended for paediatric use at this time.
Use in the elderly: A start dose of 5 mg is recommended in patients >70 years (see Precautions). 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 (CL_cr <30 ml/min/1.73m²) not on haemodialysis, dosing of CRESTOR should be started at 5 mg once daily and not to exceeded 10 mg once daily (see Pharmacology: Pharmacokinetics under Actions).
Dosage in patients with hepatic impairment: There was no increase in systemic exposure to rosuvastatin in subjects 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 (see Pharmacology: Pharmacokinetics under Actions). In these patients an assessment of renal function should be considered and the dose of CRESTOR should not exceed 20 mg once daily (see Precautions). There is no experience in subjects with Child-Pugh scores above 9. CRESTOR is contraindicated in patients with active liver disease (see Contraindications).
Race: A 5 mg starting dose of CRESTOR 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 hypercholesterolemia is not adequately controlled at doses up to 20 mg/day.
Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is 5 mg in patients with predisposing factors to myopathy (see Precautions).
Concomitant therapy: Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when CRESTOR 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 CRESTOR. Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing CRESTOR therapy. In situations where co-administration of these medicinal products with CRESTOR is unavoidable, the benefit and the risk of concurrent treatment and CRESTOR dosing adjustments should be carefully considered (see Interactions).
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 CRESTOR is recommended (see Precautions, Interactions and Pharmacology: Pharmacokinetics under Actions).