Rosuvastatin Sandoz

Rosuvastatin Sandoz





Zuellig Pharma
Concise Prescribing Info
Rosuvastatin Ca
Adjunct to diet in primary hypercholesterolaemia & mixed dyslipidaemia (type IIb) when response to diet or nonpharmacological treatments (eg, exercise, wt reduction) are inadequate. Adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate in homozygous familial hypercholesterolaemia. Prevention of CV events & major CV events in patients who are estimated to have a high risk for a 1st CV event as an adjunct to correction of other risk factors. Slow or delay the progression of atherosclerosis.
Dosage/Direction for Use
Primary hypercholesterolaemia or mixed dyslipidaemia (type IIb) Initially 5-10 mg once daily. May be adjusted after 4 wk if needed. Patients w/ severe hypercholesterolaemia at high CV risk Max dose: 40 mg once daily. Homozygous familial hypercholesterolaemia Initial dose: 20 mg once daily. Max dose: 40 mg once daily.
May be taken with or without food.
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. Severe renal impairment (CrCl <30 mL/min); myopathy; concomitant use of ciclosporin. Pregnancy & lactation.
Special Precautions
Proteinuria. Skeletal muscle effects eg, uncomplicated myalgia, myopathy & rarely rhabdomyolysis. Predisposing factors for rhabdomyolysis or myopathy eg, renal impairment, hypothyroidism, personal or family history of muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse & age >70 yr. Acute, serious conditions suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. Excessive alcohol consumption & history of liver disease. Childn.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Ciclosporin, vit K antagonists, PIs, antacid, erythromycin, OC/hormone-replacement therapy.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Rosuvastatin Sandoz FC tab 20 mg
Rosuvastatin Sandoz FC tab 10 mg
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