Crestor冠脂妥

Crestor

rosuvastatin

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Adjunctive therapy to diet to reduce elevated total-cholesterol, LDL-cholesterol, apolipoprotein B, nonHDL-cholesterol & triglycerides levels & to increase HDL-cholesterol in adult patients w/ primary hyperlipidemia & mixed dyslipidemia. Adjunct to diet to reduce total-cholesterol, LDL-cholesterol & apolipoprotein B levels in adolescent boys & girls, who are at least 1 yr post-menarche, 10-17 yr of age w/ heterozygous familial hypercholesterolemia (HeFH) (LDL-cholesterol >190 or >160 mg/dL & positive family history of premature CV disease (CVD) or ≥2 other CVD risk factors). Adjunctive therapy to diet in adult patients w/ hypertriglyceridemia. Adjunct to diet in patients w/ primary dysbetalipoproteinemia (Type III hyperlipoproteinemia). Adjunctive therapy to other lipid-lowering treatments (eg, LDL apheresis) or as monotherapy if such treatments are unavailable to reduce LDL-cholesterol, total-cholesterol & apolipoprotein B in adult patients w/ homozygous familial hypercholesterolemia. Adjunct to diet in slowing atherosclerosis progression in adult patients as part of treatment strategy to lower total-cholesterol & LDL-cholesterol. Primary prevention of CVD to reduce risk of stroke, MI & arterial revascularization procedures in patients w/o clinically evident CHD but w/ increased risk of CVD based on age ≥50 yr in men & ≥60 yr in women, hsCRP ≥2 mg/L & the presence of at least 1 additional CVD risk factor eg, HTN, low HDL-cholesterol, smoking, family history of premature CHD.
Dosage/Direction for Use
Usual initial dose: 10-20 mg once daily. Dose range: 5-40 mg once daily. 40 mg dose should be used only for patients who have not achieved LDL-C goal w/ 20 mg dose. HeFH Childn & adolescent 10-17 yr 5-20 mg/day. Max: 20 mg/day. Homozygous familial hypercholesterolemia Adult Initially 20 mg once daily. Asian patient Initially 5 mg once daily. Patient taking cyclosporine Max: 5 mg once daily. Patient taking gemfibrozil; atazanavir & ritonavir, lopinavir & ritonavir, or simeprevir Initially 5 mg once daily. Max: 10 mg once daily. Patient w/ severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. Pregnancy & lactation.
Special Precautions
Skeletal muscle effects, liver enzyme abnormalities. Concomitant therapy w/ coumarin anticoagulants. Proteinuria & hematuria; endocrine effects (eg, increases in HbA1c & fasting serum glucose levels). Patients w/ severe renal impairment. Elderly. Asian patients.
Adverse Reactions
Headache, myalgia, abdominal pain, asthenia, nausea.
Drug Interactions
Increased exposure w/ cyclosporine; gemfibrozil; atazanavir/ritonavir; lopinavir/ritonavir; simeprevir. Significantly increased INR w/ coumarin anticoagulants. Risk of skeletal muscle effects may be enhanced w/ lipid-modifying doses (≥1 g/day) of niacin. Potential risk of myopathy w/ fenofibrate, colchicine or fusidic acid. Al & Mg hydroxide combination antacid should be taken at least 2 hr after Crestor administration.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Crestor FC tab 10 mg
Packing/Price
28's
Form
Crestor FC tab 20 mg
Packing/Price
28's
Form
Crestor FC tab 5 mg
Packing/Price
28's
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