Rosufer 10 mg
Indonesia • Ferron Par Pharmaceuticals
Indication
Primary hypercholesterolemia or mixed dyslipidemia (type IIb)
Patients with primary hypercholesterolemia or mixed dyslipidemia (type IIb) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol, triglycerides and ApoB and increases HDL cholesterol.
Composition
Rosuvastatin 10 mg
Package
Dosage Forms
TabletATC Classification
Warning
Dosage
0 to 18 Years Old
Pediatric experience is limited to a small number of children (aged 8 years and over) with homozygous familial hypercholesterolemia. Therefore, rosuvastatin is not recommended for pediatric use at this time.
18 to 70 Years Old
Before initiating treatment with rosuvastatin, the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose of rosuvastatin should be individualized according to the goal of therapy and patient response using current consensus guidelines.
The recommended dose is 5 or 10 mg orally once daily in both statin-naive or patients switched from another HMG-CoA reductase inhibitor. 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. A dose adjusment to the next dose level can be made after 4 weeks, if necesary. 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 hypercholesterolemia at high cardiovascular risk (in particular those with familial hypercholesterolemia), 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. Rosuvastatin may be given at any time of day, with or without food.
Dosage in patients with predisposing factors to myopathy:
The recommended start dose is 5 mg in patients with predisposing factors to myopathy.
Interactions requiring dosage adjustments:
Gemfibrozil: Increased systemic exposure to rosuvastatin has been observed in subjects taking concomitant rosuvastatin and gemfibrozil.
70 Years Old and Above
A start dose of 5 mg is recommended in patients >70 years. No other dose adjustment is necessary.
Patients with Hepatic Insufficiency
There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below, increased systemic exposure to rosuvastatin has been observed in subjects with Child-Pugh scores of 8 and 9. In these patients an assessment of renal function should be considered, therefore the dose of rosuvastatin should not exceed 20 mg once daily. There is no experience in subjects with Child-Pugh scores above 9.
Patients with Renal Insufficiency
No dose adjustment is necessary in patients with mild to moderate renal impairment. For patients with severe renal impairment (CrCl <30 ml/minute/1.73 m2) not on hemodialysis, dosing of rosuvastatin should be started at 5 mg once daily and should not exceed 10 mg once daily.
Race
Increased plasma concentration of rosuvastatin has been in Asian subjects. Initiation of therapy with 5 mg once daily should be considered for Asian patients. The increased systemic exposure should be taken into consideration when treating Asian patients particularly in these whose hypercholesterolemia is not adequately controlled at doses up to 20 mg/daily.