Indication:
Treatment of Hypercholesterolemia:
Adults, adolescents and children aged 10 years or older with primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Homozygous familial hypercholesterolemia as an adjunct to diet and other lipid lowering treatments or if such treatments are not appropriate.
Prevention of Cardiovascular Events:
Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.
Active Ingredient:
Rosuvastatin
DOSAGE AND ADMINISTRATION
Treatment of Hypercholesterolemia:
The initial recommended dose is 5mg or 10mg orally once daily. The dose can be increased, if necessary at intervals of at least 4 weeks to next dose level once daily. When initiating therapy with Rovista Tablets or switching from another HMG-CoA reductase inhibitor therapy, the appropriate starting dose should first be utilized and only then titrated according to the patients response and individualized goal of therapy. After initiation or upon titration of Rovista Tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.
Prevention of Cardiovascular Events:
The recommended dose used is 20mg once daily.
Homozygous Familial Hypercholesterolemia:
The recommended starting dose of Rovista Tablets is 20mg once daily. Response to therapy should be estimated from preapheresis LDL-C levels.
Pediatric Population:
Pediatric use should only be carried out by specialists.
Children and Adolescents 10 to 17 years of age:
In children and adolescents with heterozygous familial hypercholesterolemia the usual start dose is 5mg daily. The usual dose range is 5-20mg orally once daily. Titration should be conducted according to the individual response and tolerability in pediatric patients. Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment.
Asian Origin:
Initially 5mg once daily increased if necessary to maximum 20mg daily.
Note:Initially 5mg once daily with concomitant fibrate increased if necessary to maximum of 20mg daily.
Renal Insufficiency:
The usual dose range applies in patients with mild to moderate renal impairment. For patients with severe renal impairment the dose of rosuvastatin should not exceed 10mg once daily.
Hepatic Insufficiency:
The usual dose range applies in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should start therapy with 10mg. Increased systemic exposure to rosuvastatin has been observed in these patients, therefore the use of doses above 10mg should be carefully considered.
Elderly: A start dose of 5mg is recommended in patients >70 years.
ADVERSE REACTIONS
Rosuvastatin is generally well tolerated. Adverse reactions have usually been mild and transient.
Common: Diabetes mellitus, Headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia.
Uncommon: Pruritus, rash and urticaria.
Rare: Pancreatitis, Hypersensitivity reactions including angioedema, myopathy, rhabdomyolysis, arthralgia, increased hepatic transaminases.
Laboratory Abnormalities: Proteinuria has been observed in patients treated with rosuvastatin. This finding was more frequent in patients taking rosuvastatin 40mg, when compared to lower doses of rosuvastatin.
Other abnormal laboratory values reported were elevated creatinine phosphokinase, dose related increase in transaminases, hyperglycemia, glutamyl transpeptidase, alkaline phosphatase, bilirubin and thyroid function abnormalities.
