Rosufer 20mg tablets

Ferron Par Pharmaceuticals

Ingredients in every tablet

Rosuvastatin 20 mg

Each package contains

3 blisters of 10 tablets

Other details

Dosage form:Tablet; coated
Flavour: None

W.H.O. classification

ATC Level 1: C - Cardiovascular system
ATC Level 2: C10 - Lipid Modifying Agents
ATC Level 3: C10A - Lipid Modifying Agents; Plain

Warnings

Pregnancy

NOT SAFEThis item is not safe for use during pregnancy.

Lactation

NOT SAFEThis item is not safe for use during lactation.

Alcohol

CAUTIONThis item may not be safe for use with alcohol. Use with caution.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution.

Available in

Indonesia

Dosage information

18 TO 70 YEARS OLD
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

70 YEARS OLD AND ABOVE
A start dose of 5 mg is recommended in patients >70 years. No other dose adjustment is necessary.

Rosuvastatin may be given at any time of day, with or without food

OTHER DETAILS
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 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 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 DOSAGE FOR PATIENTS WITH PRE-DISPOSING TO MYOPATHY The recommended start dose is 5 mg in patients with predisposing factors to myopathy INTERACTION REQUIREMENT DOSE ADJUSMENT Gemfibrozil: increased systemic exposure to rosuvastatin has been observed in subjects taking concomitant rosuvastatin and gemfibrozil

Indication

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.

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