Y.S.P. Industries


Y.S.P. Industries
Concise Prescribing Info
Rosuvastatin Ca
Adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-C, ApoB & increasing HDL-C in hyper- & dyslipidemic conditions; primary dysbetalipoproteinemia (type III hyperlipoproteinemia); combined (mixed) dyslipidemia (type IIb); homozygous familial hypercholesterolaemia; slows progression of atherosclerosis in adult patients as part of treatment strategy to lower total-C & LDL-C to target levels. Reduction of total mortality & risk of major CV events in adults w/ increased risk of atherosclerotic CV disease based on presence of CV disease risk markers.
Dosage/Direction for Use
Initially 10 mg once daily, adjust dose after 4-wk interval. Severe hypercholesterolaemia at high CV risk Increase to 40 mg. Patient requiring less agressive LDL-C reduction; Asian patient; w/ predisposing factors to myopathy Initially 5 mg once daily.
May be taken with or without food.
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases >3 times upper limit of normal (ULN); myopathy. Concomitant use w/ cyclosporin. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Discontinue use if interstitial lung disease develops & creatine kinase >5 times ULN occurs. Not to be used in patients w/ acute, serious condition of myopathy or predisposing to renal failure development secondary to rhabdomyolysis eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders or uncontrolled seizures. Predisposing factors for myopathy/rhabdomyolysis eg, hypothyroidism, history of hereditary muscular disorders, history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, conditions where increased plasma levels occur. Proteinuria; DM. Assess renal function during routine follow-up. Perform liver function test prior to & 3 mth following initiation. Excessive alcohol consumption. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be used w/ fusidic acid or w/in 7 days of discontinuation. Not recommended in combination w/ gemfibrozil; PIs. Concomitant use w/ fibrates, niacin. History of hepatic disease. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Childn <10 yr. Elderly >70 yr.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Increased plasma conc & risk of myopathy w/ OATP1B1 & BCRP inhibitors. Increased AUC w/ ciclosporin. Increased exposure w/ PIs. Increased Cmax & AUC w/ gemfibrozil & other lipid-lowering products. Increased risk of myopathy w/ fenofibrate, other fibrates, niacin (≥1 g daily). Increased AUC w/ ezetimibe. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacids. Decreased AUC & Cmax w/ erythromycin. Increased INR w/ vit K antagonist eg, warfarin or other coumarin anticoagulants. Increased ethinylestradiol & norgestrel AUC. Increased risk of myopathy & rhabdomyolysis w/ fusidic acid.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Rosuvor FC tab 10 mg
10 × 10's;3 × 10's
Rosuvor FC tab 20 mg
10 × 10's;3 × 10's
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