Lek Pharma


Concise Prescribing Info
Rosuvastatin Ca
Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. Homozygous familial hypercholesterolemia as an adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate.
Dosage/Direction for Use
Hypercholesterolemia Initially 5 or 10 mg once daily. Severe hypercholesterolemia at high CV risk Final titration to a max of 40 mg. Prevention of CV events 20 mg daily. Childn & adolescent 6-17 yr (Tanner stage <II-V above) Initially 5 mg daily. Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. Elderly >70 yr, moderate renal impairment <60 mL/min, Asian & patient w/ predisposing factors to myopathy Start dose at 5 mg.
May be taken with or without food.
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 x ULN. Severe renal impairment (CrCl <30 mL/min). Myopathy. Patients receiving concomitant ciclosporin. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Proteinuria. Skeletal muscle effects eg, myalgia, myopathy & rarely, rhabdomyolysis. Clinical monitoring of creatinine kinase levels monitoring is recommended. Discontinue therapy if CK levels are markedly elevated (>5 x ULN). Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Not to be used in patients w/ acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Carry out liver function tests prior to & 3 mth following the initiation of treatment. Discontinue or reduce dose if the level of serum transaminases is >3 x ULN. Patients w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome. Concomitant use w/ PIs. Interstitial lung disease. DM. May affect ability to drive or operate machinery. Women of childbearing potential. Childn <6 yr. Asians.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Increase INR w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant). Increase in ethinyl estradiol & norgestrel AUC. Increased risk of myopathy w/ fusidic acid.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Robestar FC tab 10 mg
Robestar FC tab 20 mg
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