Celmantin

Rosuvastatin Ca

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. Reduces elevated LDL-cholesterol, total cholesterol (total-C) & triglycerides (TG) & increases HDL-cholesterol. Lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios & increases ApoA-I. Homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis). Primary prevention of CV disease (reduces risk of stroke, MI & arterial revascularization procedures). Reduction of total-C, LDL-C & ApoB levels as an adjunct to diet in childn & adolescents 10-17 yr (who are at least 1 yr post-menarche in girls) w/ heterozygous familial hypercholesterolaemia.

Individualized dosage. Statin-naive patient or those who switched from another HMG-CoA reductase inhibitor Initially 5 or 10 mg once daily. Adjust to the next dose level after 4-6 wk, if necessary. Patient w/ severe hypercholesterolaemia at high CV risk (familial hypercholesterolaemia) May be increased to 40 mg only if treatment goal is not achieved on 20 mg. Asian patient Initially 5 mg once daily. Paed patient w/ heterozygous familial hypercholesterolaemia Initially 5 mg once daily. Max: 10 mg daily. Adjust doses at ≥4 wk intervals. Patient known to have c.521CC or c.421AA genotype Max: 20 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained, persistent serum transaminase elevations. Concomitant use w/ cyclosporin. Severe renal impairment (CrCl <30 mL/min). Women of child-bearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Doses >20 mg should be closely supervised during initiation & periodically re-evaluated for long-term risk/benefit. Asian patients. Consider dose reduction in patients w/ unexplained, persistent proteinuria during routine urinalysis testing; renal function assessment is recommended during routine follow-up of patients treated w/ 40-mg dose. Possible skeletal muscle effects (eg, myalgia, myopathy & rarely, rhabdomyolysis). Not to measure creatinine kinase (CK) following strenuous exercise or in the presence of a plausible alternative cause of CK increase, for possible confound result interpretation. Patients w/ pre-disposing factors for myopathy/rhabdomyolysis (eg, renal impairment; hypothyroidism; personal or family history of hereditary muscular disorders; history of muscular toxicity w/ another HMG-CoA reductase inhibitor, fibrate or niacin; alcohol abuse; age ≥65 yr; situations where increased plasma levels occur; concomitant use of fibrates or niacin). Measure CK levels in patients w/ inexplicable muscle pain, weakness or cramps particularly if associated w/ malaise or fever; discontinue if CK levels are markedly elevated (>10 x ULN) or if muscular symptoms are severe & cause daily discomfort. Temporarily 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). Increased HbA1c & serum glucose levels. Excessive alcohol consumption &/or history of liver disease. Perform liver function tests prior & at 3 mth following both treatment initiation & any dose increase, & periodically (semi-annually) thereafter; monitor patients w/ increased transaminases; discontinue or reduce dose if serum transaminase level is >3 ULN. Concomitant use w/ various PIs in combination w/ ritonavir. Dizziness may occur during treatment; may affect ability to drive vehicles or operate machines. Moderate & severe hepatic impairment. Childn & adolescents 10-17 yr.

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

May increase plasma conc & risk of myopathy w/ transporter protein inhibitors. Increased steady state AUC_(0-t) by cyclosporin. Exposure may be strongly increased w/ PI. Increased C_max & AUC_(0-t) by gemfibrozil; increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses (≥1 g/day) of niacin. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacids. Decreased AUC_(0-t) & C_max by erythromycin. May elevate INR w/ warfarin. Increased AUC of ethinyl oestradiol & norgestrel. Caution during concomitant use w/ 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.

Dyslipidaemic Agents

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

POM