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Rosudex 20mg tablets

Dexa Medica

Ingredients in every tablet

Rosuvastatin 20 mg

Each package contains

3 strips of 10 tablets

Dosage form

tablet

Dosage formTablet; coated

Flavour

None

W.H.O. classification

C10A
C10A

A.T.C. Level 1

Anatomical Main group

C - Cardiovascular system
C10A

A.T.C. Level 2

Therapeutic subgroup

C10 - Lipid Modifying Agents
C10A

A.T.C. Level 3

Pharmacological subgroup

C10A - Lipid Modifying Agents; Plain

Available in

Cambodia

Warnings

Alcohol

CAUTIONThis item may not be safe for use with alcohol. Use with caution and after consultation with your doctor.

Machinery

CONSULT YOUR DOCTORSafety of this item for use while operating heavy machinery has not been established. Please consult your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

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.

Dosage

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.

0 TO 18 YEARS OLD
Rosuvastatin is not recommended for pediatric use at this time.

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
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.