Rosudex 20 mg

Cambodia • Dexa Medica

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.

Composition

Rosuvastatin 20 mg

Package

3 strips of 10 tablets

Dosage Forms

Tablet

ATC Classification

C10A

Warning

Alcohol
Caution
This item may not be safe for use with alcohol. Use with caution and after consultation with your doctor.
Machinery
Consult Your Doctor
Safety of this item for use while operating heavy machinery has not been established. Please consult your doctor.
Pregnancy
Not Recommended
This item is not safe for use during pregnancy.
Lactation
Not Recommended
This item is not safe for use during lactation.

Dosage

0 to 18 Years Old

Rosuvastatin is not recommended for pediatric use at this time.

18 Years Old and Above

The recommended start dose is 5 or 10 mg orally once daily daily in both statin-naive or patients switched from another HMG-CoA reductase inhibitor.

A dose adjusment to the next dose level can be made after 4 weeks, if necessary. 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.

Administration

Specialist supervision is recommended when the 40 mg dose is initiated. Rosuvastatin may be given at any time of day, with or without food.

Elderly Patients

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

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/min/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.

Patients with Hepatic Insufficiency

The dose of rosuvastatin should not exceed 20 mg once daily.

Race

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.

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