Crestor

Crestor

rosuvastatin

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Prevention of CV events to reduce total mortality & risk of major CV events (eg, CV death, stroke, MI, unstable angina or arterial revascularization) in adult patients w/ an increased risk of atherosclerotic CV disease. Reduces elevated LDL-C, total cholesterol, triglycerides & increases HDL-C in patients w/ primary hypercholesterolaemia (heterozygous familial & nonfamilial) & mixed dyslipidaemia (Fredrickson types IIa & IIb). Lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios & increases ApoA-I in adult patients w/ hypercholesterolaemia. Primary dysbetalipoproteinaemia (Fredrickson type III hyperlipoproteinaemia), isolated hypertriglyceridaemia (Fredrickson type IV hyperlipidaemia). Reduces total cholesterol & LDL-C in patients w/ HoFH as an adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or alone. Slows or delays progression of atherosclerosis. In childn & adolescents 6-17 yr, reduces total cholesterol, LDL-C & ApoB in patients w/ heterozygous familial hypercholesterolaemia (HeFH).
Dosage/Direction for Use
10-40 mg once daily. Adult Primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia, dysbetalipoproteinaemia, isolated hypertriglyceridaemia, atherosclerosis & prevention of CV events Initially 10 mg once daily; may start w/ 5 mg for special patient population if needed. Severe hypercholesterolaemia (including heterozygous familial hypercholesterolaemia) or w/ aggressive lipid target Initially 20 mg. HoFH Initially 20 mg once daily. Childn w/ heterozygous familial hypercholesterolaemia 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. Severe renal/hepatic impairment Max: 10 mg once daily. Asian patients Initially 5 mg. Patients known to have the c.521CC or c.421AA genotype Max: 20 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease.
Special Precautions
Excessive consumption of alcohol; history of liver disease. Skeletal muscle effects eg, myalgia, myopathy & rhabdomyolysis. Monitor CK levels in patients who develop any signs or symptoms suggestive of myopathy. Discontinue therapy if CK levels are elevated (>10 x ULN) or if myopathy is diagnosed or suspected. Discontinue if myasthenia gravis or ocular myasthenia is induced or aggravated. Patients w/ predisposing factors for myopathy eg, renal impairment, advanced age & hypothyroidism or in occurrence of increased plasma levels. W/hold in patients w/ acute serious condition 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). DM. Patients at high risk for developing diabetes; Asian patients. Not recommended during pregnancy & lactation. Discontinue as soon as pregnancy is recognized.
Adverse Reactions
Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, DM.
Drug Interactions
Increased plasma conc & risk of myopathy w/ sofosbuvir/velpatasvir/voxilaprevir, voxilaprevir, ciclosporin, darolutamide, regorafenib, atazanavir/ritonavir, roxadustat, simeprevir, velpatasvir, ombitasvir/paritaprevir/ritonavir/dasabuvir, teriflunomide, enasidenib, grazoprevir/elbasvir, glecaprevir/pibrentasvir, lopinavir/ritonavir, capmatinib, clopidogrel, tafamidis, fostamatinib, febuxostat, gemfibrozil, eltrombopag, darunavir/ritonavir, tipranavir/ritonavir, dronedarone, itraconazole, ezetimibe. Decreased AUC w/ erythromycin, baicalin. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Possibility of muscle-related events including rhabdomyolysis w/ fusidic acid. Rise in INR w/ warfarin. Increased risk of myopathy w/ gemfibrozil, fenofibrates & other fibric acids including nicotinic acid.
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
30's
Form
Crestor FC tab 20 mg
Packing/Price
30's
Form
Crestor FC tab 40 mg
Packing/Price
30's
Form
Crestor FC tab 5 mg
Packing/Price
30's
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