Roxatin Dosage/Direction for Use

Patients should be placed on a standard cholesterol-lowering diet (at least equivalent to the Adult Treatment Panel III (ATP III TLC diet)) before receiving Rosuvastatin, and should continue on this diet during treatment with Rosuvastatin. If appropriate, a program of weight control and physical exercise should be implemented.
Prior to initiating therapy with Rosuvastatin secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed. After initiation or upon titration of Rosuvastatin, lipid levels should be analyzed within 2-4 weeks and the dosage adjusted accordingly.
The usual recommended starting dosage of Rosuvastatin 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 patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. Rosuvastatin 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 Rosuvastatin at a dose higher than 20 mg should periodically re-evaluate the long-term risk/benefir of Rosuvastatin for the individual patient. Rosuvastatin should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis.
The dosage of Rosuvastatin 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 Rosuvastatin adjusted based on target lipid levels recommended by guidelines.
Dosage in patients with renal insufficiency: The usual dose range applies in patients with mild to moderate renal impairment.
The use of Rosuvastatin Calcium in patients with severe renal impairment is contraindicated.
Dosage in patients with hepatic insufficiency: 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. There is no experience in subjects with Child-Pugh scores above 9. Rosuvastatin calcium is contraindicated in patients with active liver disease.
Use in elderly: The overall frequency of adverse events and types of adverse events were similar in patients above and below 65 years of age. The efficacy of Rosuvastatin in the geriatric population (≥65 years of age) was comparable to the efficacy observed in the non-elderly.
Pediatric patients (10 to 17 years of age): In pediatric patients (10 to 17 years of age) with heterozygous familial hypercholesterolaemia& the usual dose range of Rosuvastatin is 5-20 mg/day; the maximum recommended dose is 20mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualised according to the recommended goal 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 eight patients (aged 8 years and above).
Dose on Asian patients: Initiation of Rosuvastatin calcium 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 increased Rosuvastatin exposure (see Pharmacology: Pharmacokinetics under Actions). For patients who are known to have such specific types of polymorphisms, a lower daily dose of Rosuvastatin is recommended.
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/ortipranavir). 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.
Roxatin Tablet 10mg and Roxatin Tablet 20mg are not able to deliver all approved dose regimens of Rosuvastatin. Therefore, other approved dosage forms and strengths of rosuvastatin should be used in such cases.
Route of Administration: Oral.