Rovastin Dosage/Direction for Use





Full Prescribing Info
Dosage/Direction for Use
Patients should be placed on a standard cholesterol-lowering diet (at least equivalent to the ATP III TLC diet) before receiving Rovastin and should continue on this diet during treatment with Rovastin. If appropriate, a program of weight control and physical exercise should be implemented.
Prior to initiating therapy with Rovastin, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed. After initiation or upon titration of Rovastin, lipid levels should be analyzed within 2-4 weeks and the dosage adjusted accordingly.
The usual recommended starting dose of Rovastin is 10 mg once daily. However, initiation of therapy with 5 mg once daily should be considered for special patient populations or patients requiring less aggressive LDL-C reductions. 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. Rovastin may be taken in the morning or evening, with or without food. The majority of patients are controlled at the 10-mg dose. However, if necessary, dose adjustments to the next dose level can be made after 4-week intervals. The maximum response is usually achieved within 2-4 weeks and is maintained during chronic therapy. Increasing the dose to 40 mg should be reserved for 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 should only be initiated under specialist supervision (see Precautions). The physician who elects to use Rovastin at a dose higher than 20 mg should periodically re-evaluate the long-term risk/benefit of Rovastin for the individual patient. Rovastin should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis (see Precautions).
The dosage of Rovastin should be individualised according to baseline LDL-C, total-C/HDL-C ratio and/or TG levels, the recommended target lipid values and the patient response.
Lipid levels should be monitored periodically and, if necessary, the dose of Rovastin adjusted based on target lipid levels recommended by guidelines.
Patients with Renal Insufficiency: The usual dose range applies in patients with mild to moderate renal impairment. The use of Rovastin in patients with severe renal impairment is contraindicated.
Patients with Hepatic Insufficiency: Rovastin is contraindicated in patients with active liver disease.
Pediatric Patients (10-17 years of age): In pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia (HeFH), the usual dose range of Rovastin is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.
Use in Children below 10 years: The safety and effectiveness in children have not been established. In children and adolescents with homozygous familial hypercholesterolemia, experience is limited to 8 patients (aged 8 years and above).
Dosage in Asian Patients: Initiation of Rovastin therapy with 5 mg once daily should be considered for Asian patients. The potential for increased systemic exposures relative to Caucasians is relevant when considering escalation of dose in cases where hypercholesterolaemia is not adequately controlled at doses of 5, 10 or 20 mg once daily.
Genetic polymorphisms: Specific types of genetic polymorphisms are known that can lead to increase rosuvastatin exposure (see Pharmacology: Pharmacokinetics under Actions). For patients who are known to have such specific types of polymorphisms, a lower daily dose of Rovastin is recommended.
Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is 5mg in patients with pre-disposing 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. certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing Rovastin 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.
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