Rosuvastatin Sandoz

Rosuvastatin Ca

Treatment of primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) in adults, adolescents & childn ≥6 yr, as an adjunct to diet when response to diet & other non-pharmacological treatments is inadequate; homozygous familial hypercholesterolaemia as an adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. Prevention of major CV events in patients who are estimated to have a high risk for a 1st CV event, as an adjunct to correction of other risk factors.

Adult Hypercholesterolaemia Initially 5 mg or 10 mg once daily. Max: 40 mg. Prevention of CV events 20 mg daily. Childn 6-17 yr Heterozygous familial hypercholesterolaemia Initially 5 mg. Usual dose range: 5-10 mg once daily (childn 6-9 yr); 5-20 mg once daily (childn 10-17 yr).

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3x the upper limit of normal (ULN); severe renal impairment (CrCl <30 mL/min); myopathy. Concomitant use w/ ciclosporin. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation. 40-mg dose: Patients w/ pre-disposing factors for myopathy/rhabdomyolysis including moderate renal impairment (CrCl <60 mL/min), 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, Asian patients, concomitant use of fibrates.

Proteinuria w/ higher doses. Skeletal muscle effects eg, myalgia, myopathy &, rarely, rhabdomyolysis. Caution in patients w/ predisposing factors for myopathy/rhabdomyolysis; patients who consume excessive quantities of alcohol &/or have a history of liver disease. Perform liver function tests prior to treatment & 3 mth following treatment initiation. Increased exposure in Asian patients. Cases of interstitial lung disease especially w/ long-term therapy. Statins as a class may raise blood glucose. Concomitant use w/ PIs is not recommended unless rosuvastatin dose is adjusted. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Patients w/ moderate renal or hepatic impairment. Patients w/ genetic polymorphisms that can lead to increased rosuvastatin exposure. Women of childbearing potential should use appropriate contraceptive measures. Not recommended in childn <6 yr.

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

Increased plasma conc & increased risk of myopathy w/ OATP1B1 & BCRP inhibitors; ciclosporin; PIs; gemfibrozil; ezetimibe. Increased risk of myopathy w/ gemfibrozil, fenofibrate other fibrates & lipid-lowering doses of niacin; systemic fusidic acid. Decreased plasma conc w/ antacids containing Al & Mg hydroxide; erythromycin. Increased INR w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant). Increased plasma levels of ethinyl estradiol & norgestrel.

Dyslipidaemic Agents

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

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