United Pharma


Concise Prescribing Info
Rosuvastatin Ca
Adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate in adults, adolescents & childn ≥6 yr w/ primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb). Adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate in adults, adolescents & childn ≥6 yr w/ homozygous familial hypercholesterolaemia. Decrease elevated total cholesterol (total-C), LDL-cholesterol (LDL-C) & triglycerides (TG) & increase high density lipoprotein cholesterol (HDL-C) in adults w/ primary hypercholesterolemia (heterozygous familial & non-familial) or mixed dyslipidemia (Fredrickson types IIa & IIb). Decrease Apo B, non-HDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C & Apo B/Apo A-I ratios & increase Apo A-I in adults. Isolated hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Primary dysbetalipoproteinemia (Fredrickson type III hyperlipoproteinemia). Decrease total-C & LDL-C in patients w/ homozygous familial hypercholesterolaemia as adjunct to other lipid-lowering treatments or alone. Slow progression of atherosclerosis to decrease total-C & LDL-C. Decrease total-C, LDL-C & Apo B levels in childn & adolescents 6-17 yr (boys ≥ Tanner Stage II & girls who are at least 1 yr post-menarche) w/ heterozygous familial hypercholesterolaemia. Decrease risk of stroke, MI & arterial revascularization procedures in individuals w/o clinically evident CHD but w/ increased risk of CV disease.
Dosage/Direction for Use
Individualized dosage. Hypercholesterolaemia Initially 5 or 10 mg once daily in both statin-naive or patients switched from another HMG-CoA reductase inhibitor. Severe hypercholesterolaemia Max: 40 mg. Prevention of CV events 20 mg daily. Heterozygous familial hypercholesterolaemia Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. Max: 20 mg once daily. Adjust dose at intervals of ≥4 wk if necessary. Homozygous familial hypercholesterolaemia Adult Initially 20 mg once daily. Childn 6-17 yr Initially 5-10 mg once daily. Max: 20 mg once daily. Hyperlipidemia (including heterozygous familial hypercholesterolaemia, mixed dyslipidemia, isolated hypertriglyceridemia, slowing of progression of atherosclerosis) Adult Initially 10 mg once daily. Severe hypercholesterolaemia (including heterozygous familial hypercholesterolaemia) 20 mg once daily. Patient w/ moderate renal impairment (CrCl <60 mL/min), w/ predisposing factors to myopathy Initially 5 mg. Elderly >70 yr Initially 5 mg.
May be taken with or without food.
Hypersensitivity. Active liver disease; myopathy. Concomitant use w/ ciclosporin. Use of 40 mg dose in patients w/ predisposing factors for myopathy/rhabdomyolysis. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.
Special Precautions
Discontinue use if creatinine kinase levels are markedly elevated (>5 x ULN) or muscular symptoms are severe; suspected interstitial lung disease. Not to be used in patients w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis. Predisposing factors for myopathy/rhabdomyolysis; DM. Patients w/ excessive alcohol consumption &/or history of liver disease. Assess renal function during routine follow-up. Carry out liver function tests prior to & 3 mth following initiation of treatment. Not recommended in concomitant use w/ fibric derivatives eg, gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, PIs & macrolides. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May cause dizziness which may affect ability to drive & use machines. Renal impairment. Women of childbearing potential should use effective contraception. Not recommended in childn <6 yr. Elderly >70 yr.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Plasma conc & risk of myopathy may be increased w/ inhibitors of hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Increased AUC w/ ciclosporin; ezetimibe. May strongly increase exposure w/ PIs. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & niacin (≥1 g daily). Decreased plasma conc w/ antacid containing Al & Mg hydroxide. Decreased AUC & Cmax w/ erythromycin. May increase INR w/ vitamin K antagonists eg, warfarin or coumarin anticoagulants. Increased ethinyl estradiol & norgestrel AUC. May increase risk of myopathy including rhabdomyolysis w/ fusidic acid.
MIMS Class
Dyslipidaemic Agents
Perosu FC tab 10 mg
3 × 10's
Perosu FC tab 20 mg
3 × 10's
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