Crestor

Crestor

rosuvastatin

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Primary hypercholesterolaemia & mixed dyslipidaemia (including Fredrickson type IIa, IIb; & heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet & exercise is inadequate. Primary dysbetalipoproteinaemia (Fredrickson type III hyperlipoproteinaemia) as an adjunct to diet when response to diet & exercise is inadequate. Reduction of elevated LDL-C, total-C & triglycerides & increase of HDL-C. Reduction of ApoB, nonHDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios & increase of ApoA-I. Homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet & other lipid-lowering treatments. Primary prevention of CV disease (reduce the risk of stroke, MI & arterial revascularization procedures). Reduction of total-C, LDL-C & ApoB levels in childn & adolescents 10-17 yr as an adjunct to diet.
Dosage/Direction for Use
Individualised dosage. Initially 5 mg or 10 mg once daily in both statin-naive patients or patients switched from another HMG-CoA reductase inhibitor, may be adjusted to the next dose level after 4-6 wk, if necessary. Severe hypercholesterolemia at high CV risk May be increased to 40 mg. Asian patient Initially 5 mg once daily. Childn w/ heterozygous familial hypercholesterolemia Initially 5 mg once daily. Max: 10 mg daily. Adjustments should be made at ≥4-wk intervals.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained, persistent elevations of serum transaminases. Concomitant cyclosporin therapy. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Asian patients. Unexplained, persistent proteinuria during routine urinalysis testing. Predisposing factors for myopathy/rhabdomyolysis (eg, renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, history of muscular toxicity w/ other HMG-CoA reductase inhibitors, fibrates or niacin, alcohol abuse, situations where increased plasma levels occur & concomitant use of fibrates or niacin). Measure creatinine kinase levels in patients who report inexplicable muscle pain, weakness or cramps particularly if associated w/ malaise or fever. Temporarily w/hold in patients w/ acute serious conditions suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures). Increased HbA1c & serum glucose levels. Excessive alcohol consumption &/or history of liver disease. Increasing the dose to 40 mg should only be reserved for patients w/ severe hypercholesterolaemia at high CV risk who do not achieve their treatment goal on 20 mg & should only be initiated under close specialist supervision. Concomitant use of various PI. Limit to max 10 mg/day dose if combined w/ fibrates or lipid-lowering doses of niacin (≥1 g/day). May affect ability to drive or operate machinery. Moderate & severe hepatic impairment. The evaluation of linear growth, wt, BMI & secondary characteristics of sexual maturation by Tanner staging in childn & adolescents 10-17 yr taking rosuvastatin is limited to 1-yr period. Elderly ≥65 yr.
Adverse Reactions
Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, DM.
Drug Interactions
Increased plasma conc & risk of myopathy w/ inhibitors of hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Increased steady state AUC(0-t) w/ cyclosporin. Increased exposure w/ PI. Increased Cmax & AUC(0-t) w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses (≥1g/day) of niacin. Decreased plasma conc w/ antacids containing Al & Mg hydroxide. Decreased Cmax & AUC(0-t) w/ erythromycin. Elevation in INR of warfarin. Increased AUC of ethinyl oestradiol & norgestrel. Drugs that may decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine). Risk of muscle related events, including rhabdomyolysis w/ fusidic acid.
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 20 mg
Packing/Price
28's
Form
Crestor FC tab 5 mg
Packing/Price
28's
Form
Crestor FC tab 10 mg
Packing/Price
28's
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