Rozact Dosage/Direction for Use



Full Prescribing Info
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.
Rosuvastatin may be given at any time of day, with or without food.
The recommended start dose is 5 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. 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.
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 hypercholesterolemia. Therefore, Rosuvastatin 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. 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 (CLcr < 30 mL/minute/1.73 m2) not on haemodialysis, 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 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. In these patients an assessment of renal function should be considered and the dose of Rosuvastatin should not exceed 20 mg once daily. There is no experience in subjects with Child-Pugh scores above 9. Rosuvastatin is contraindicated in patients with active liver disease.
Race: A 5 mg starting dose of Rosuvastatin should be considered for Asian patients. Increased plasma concentration of Rosuvastatin has been seen in Asian subjects. 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 daily.
Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is 5 mg in patients with predisposing factors to myopathy.
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 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). Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing Rosuvastatin therapy. In situations where co-administration of these medicinal products with Rosuvastatin is unavoidable, the benefit and the risk of concurrent treatment and Rosuvastatin dosing adjustments should be carefully considered (see INTERACTIONS).
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