Concise Prescribing Info
Rosuvastatin Ca
Adjunct to diet for reduction of elevated total-C, LDL-C, Apo B & for increasing HDL-C in hyper- & dyslipidemic conditions; patients w/ primary dysbetalipoproteinemia (type III hyperlipoproteinemia). 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. Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia & severe non-familial hypercholesterolaemia); combined (mixed) dyslipidemia (type IIb); HoFH. Adjunctive therapy to diet to slow progression of atherosclerosis in adults as part of treatment strategy to lower total-C & LDL-C to target levels. Adjunct to diet to reduce total-C, LDL-C & Apo B levels in adolescent boys & girls 10-17 yr w/ heterozygous familial hypercholesterolemia.
Dosage/Direction for Use
Adult Initially 5-10 mg once daily, may be adjusted after 4 wk. Severe hypercholesterolemia at high CV risk (including w/ familial hypercholesterolemia) Increase dose to 40 mg. Ped patient 10-17 yr 5-20 mg daily, may be adjusted after ≥4 wk. Asian patient & 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 ULN. Patients w/ myopathy. Concomitant use w/ cyclosporine. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.
Special Precautions
Discontinue use if ILD develops. Not to be initiated if baseline creatine kinase >5 times ULN. Not be used in patients w/ acute, serious condition suggestive 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. Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, hypothyroidism, personal or family history of hereditary muscular disorders; previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrates, situations increasing plasma levels; DM. Monitor lipid levels periodically. Assess renal function during routine follow-up. Perform LFT prior to & 3 mth following initiation. Asian patients; genetic polymorphisms. Alcohol abuse. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in combination w/ gemfibrozil. Concomitant use w/ certain PIs; ezetimibe, fibrates, niacin. Renal impairment. 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 w/ OATP1B1 & BCRP inhibitors. Increased exposure w/ PIs. Increased Cmax & AUC w/ gemfibrozil, other lipid-lowering products. Increased risk of myopathy, severe myositis & myoglobinuria w/ fenofibrate, other fibrates. Increased AUC w/ ezetimibe. Decreased plasma conc w/ Al- & Mg-containing antacid susp. Muscle-related events w/ fusidic acid. Decreased AUC & Cmax w/ erythromycin. Increased INR w/ vit K antagonists. Increased ethinyl estradiol, norgestrel levels. Not to be used w/ ciclosporin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Rovastin FC tab 10 mg
2 × 14's
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