All the Active Ingredient Drugs
Statin. Rosuvastatin (as Calcium) 5, 10, 20, 40 mg. TABS: 28 x 5mg, 10 mg, 20 mg, 40
mg. Not to be chewed, crushed or
divided. May be given at any time of the
day, with or without food. Bef. tmt.
initiat. pt. to be on a standard
cholesterol-lower. diet that should
contin. dur. tmt. Individual. accord. to
the goal of the ther. and pt.
response. Start dose: 10 mg 1 x dly. Dose
adjust. to 20 mg can be made after 4 wks if necess. 40 mg only in pts. with
severe hypercholesterolem. at high CV
risk who do not achieve their tmt. goal
on 20 mg. Follow-up routine to be
performed. Not recommend. for ped.
No dos adjust. necess in elderly, or pts.
with mild to mod. ren. impair. Hepat.
impair. pts. with Child-Pugh scores of 8
and 9: Assess. of ren. funct. should be
considered.
Prim. hypercholesterolem. (type IIa incl.
heterozygous famil.
hypercholesterolem.) or mixed
dyslipidem. (type IIb) as an adjunct to
diet when response to diet and other
non-pharmacolog. tmts. (e.g exercise,
wt. reduct.) is inad. Homozygous famil.
hypercholesterolem. as an adjunct to
diet and other lipid lower. tmts (e.g. LDL
apheres.) or if such tmts. not approp.
C/I: Hypersens. to rosuvastatin or to any of
the excips.; active liver dis. incl.
unexplain., persist. elevat. serum
transaminases and any serum
transaminase elevat. exceed. 3 x the
upper limit of normal (ULN); severe ren.
impair. (creatinine clear. <30ml/min);
myopath. pts. receiv. concom.
cyclosporin; pregn., lact., women of
childbearing potential not using approp.
contracept. measures.
Statin. Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg. FC tabs 30 X 5/10/20/40 mg
The recommended start dose is 5 mg or 10 mg once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. Dose adjustment to the next dose level can be made after 4 weeks.
Adlts with: Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other nonpharmacological treatments (e.g. exercise, weight reduction) is inadequate.Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
C/I: hypersensitivity
- in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN).
- in patients with severe renal impairment (creatinine clearance <30 ml/min).
- in patients with myopathy.
- in patients receiving concomitant combination of sofosbuvir/velpatasvir/voxilaprevir
- in patients receiving concomitant ciclosporin.
- pregnancy and lactation
40 mg in pts with pre-disposing factors for myopathy/rhabdomyolysis:
- moderate renal impairment (creatinine clearance < 60 ml/min)
- hypothyroidism
- personal or family history of hereditary muscular disorders
- previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
- alcohol abuse
- situations where an increase in plasma levels may occur
- Asian patients
- concomitant use of fibrates.
Statin. Rosuvastatin (as Calcium) 5, 10, 20, 40 mg. TABS: 28 x 5 mg, 10 mg, 20 mg, 40 mg.
Not to be chewed, crushed or divided.
May be given at any time of the day,
with or without food. Bef. tmt. initiat.
pt. to be on a standard cholesterollower.
diet that should contin. dur. tmt.
Individual. accord. to the goal of the
ther. and pt. response. Start dose: 10
mg 1 x dly. Dose adjust. to 20 mg can
be made after 4 wks if necess. 40 mg
only in pts. with severe
hypercholesterolem. at high CV risk
who do not achieve their tmt. goal on
20 mg. Follow-up routine to be
performed. Not recommend. for ped.
No dos adjust. necess in elderly, or pts.
with mild to mod. ren. impair. Hepat.
impair. pts. with Child-Pugh scores of 8
and 9: Assess. of ren. funct. should be
considered.
Prim. hypercholesterolem. (type IIa incl.
heterozygous famil.
hypercholesterolem.) or mixed
dyslipidem. (type IIb) as an adjunct to
diet when response to diet and other
non-pharmacolog. tmts. (e.g. exercise,
wt. reduct.) is inad. Homozygous famil.
hypercholesterolem. as an adjunct to
diet and other lipid lower. tmts (e.g. LDL
apheres.) or if such tmts. not approp.
C/I: Hypersens. to rosuvastatin or to any
of the excips.; active liver dis. incl.
unexplain., persist. elevat. serum
transaminases and any serum
transaminase elevat. exceed. 3 x the
upper limit of normal (ULN); severe ren.
impair. (creatinine clear. <30ml/min);
myopath. pts. receiv. concom.
cyclosporin; pregn., lact., women of
childbearing potential not using
approp. contracept. measures.
