Inovamed Pharma Ltd.

Statin. Rosuvastatin 10 mg, 20 mg, 40 mg.
FCTabs : 30 X 10/20/40 mg
Recomm. start dose is 5 mg or 10 mg once /d in both statin naïve or pts switched from another HMG CoA reductase inhib. The choice of start dose should take into account the indiv. cholesterol level and future CV risk as well as the potent. risk for adverse reactions . Dose adjustm. to the next dose level can be made after 4 weeks, if necessary.
  For adults with:• primary hypercholesterolaemia (type IIa including heterozygous familial hypercholest.) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological tmts. (e.g. exercise weight reduction) is inadequate.• Homozygous familial hypercholest. as adjunct to diet and other lipid lowering tmts. (e.g. LDL apheresis) or if such tmts are not appropriate.
C/I: Hypersens./In pts.with active liver dis. incl. unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN)/ In pts with sev. renal impairm. (creatinine clearance <30 ml/min)/ In pts with myopathy/ In pts receiving concom. combin. of sofosbuvir/ velpatasvir/ voxilaprevir/ In pts receiving concom. ciclosporin/ During pregn. and lact. and in women of childbearing pot. not using appropriate contraceptive measures.
The 40 mg dose is contraind. in pts with pre-disposing factors for myopathy/rhabdomyolysis:- mod. renal impairm. (creatinine clearance < 60 ml/min)
- hypothyroidism - personal or family hist. of hereditary musc. disorders
- prev. hist. of musc. tox. with another HMG-CoA reductase inhib. or fibrate
- alcohol abuse - situations where an incr. in plasma levels may occur
- Asian pts - concom. use of fibrates. - In pts < 18 years