Vivacor 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.
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 (see Pharmacology: Pharmacodynamics under Actions). A doubling of the dose to 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).
VIVACOR 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 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).
Use in the elderly: No dose adjustment is necessary.
Dosage in patients with renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. The use of VIVACOR in patients with severe renal impairment is contraindicated (see Contraindications and 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 (see Precautions). There is no experience in subjects with Child-Pugh scores above 9. VIVACOR is contraindicated in patients with active liver disease (see Contraindications).
Race: A 5 mg starting dose of VIVACOR 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 particularly in those 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 VIVACOR 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 VIVACOR is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. cyclosporin, ticagrelor 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 VIVACOR. Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing VIVACOR therapy. In situations where co-administration of these medicinal products with VIVACOR is unavoidable, the benefit and the risk of concurrent treatment and VIVACOR dosing adjustments should be carefully considered (see Interactions).