Crestor

Rosuvastatin Ca

Primary hypercholesterolaemia (type IIa, including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet & exercise is inadequate. Reduction of elevated LDL-cholesterol, total cholesterol, triglycerides & Apo B & increase in HDL-C. Homozygous familial hypercholesterolaemia as an adjunct to diet & other lipid-lowering treatment (eg, LDL aphaeresis).

Individualized dosage. Initially 5 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 wk, if necessary. Severe hypercholesterolaemia at high CV risk Max: 40 mg. Elderly >70 yr, patient w/ predisposing factors to myopathy & Asian patient Initially 5 mg. 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. Patient w/ hepatic impairment (Child-Pugh score 8 & 9) Max: 20 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 x ULN; myopathy; concomitant cyclosporin therapy. Women of childbearing potential, pregnancy & lactation.

Consider renal function assessment during routine follow-up in patients treated w/ 40 mg dose. Patients who consume excessive quantities of alcohol &/or have a history of liver disease; w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome. Perform LFTs prior to initiation of therapy & 3 mth later. Patients should be advised to report promptly any inexplicable muscle pain, weakness or cramps, particularly if associated w/ malaise or fever. Discontinue therapy in markedly elevated creatinine kinase or if muscular symptoms are severe & cause daily discomfort. Patients w/ predisposing factors for myopathy/rhabdomyolysis. Renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels may occur, concomitant use of fibrates. Additional neuromuscular & serologic testing may be necessary. Increased HbA1c & serum glucose level. Patients at high risk for developing diabetes; Asian patients. Concomitant administration w/ products that interact w/ protein transporter (eg, OATP1B1 & BCRP). Patients known to have the c.521CC or c.421AA genotype. May impair ability to drive or operate machinery. Childn. Elderly >70 yr.

DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.

Increased plasma conc & increased risk of myopathy w/ inhibitors of OATP1B1 & BCRP transporters. Increased C_max and AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & niacin. Increased AUC w/ ezetimibe in hypercholesterolaemic subjects. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased C_max & AUC w/ erythromycin. Increased AUC w/ sofosbuvir/velpatasvir/voxilaprevir, voxilapevir, ciclosporin, darolutamide, regorafenib, atanazavir/ritonavir, simeprevir, velpatasvir, ombitasvir/paritaprevir/ritonavir/dasabuvir, grazoprevir/elbasvir, glecaprevir/pibrentasvir, lopinavir/ritonavir, clopidogrel, gemfibrozil, eltrombopag, darunavir, tipranavir, dronedarone, itraconazole, ezetimibe. Decreased AUC w/ baicalin. May either increase or decrease INR in patients taking Vit K antagonists (eg, warfarin). Increased AUC of ethinyl estradiol & norgestrel. Increased exposure in patients known to have the c.521CC or c.421AA genotype.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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