All the Drug Class 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. Atorvastatin (as calcium) 10, 20, 40, 80 mg. F.C. TABS: 30 x 10 mg, 20 mg. Init: 10-20-
mg 1 x dly. Pts requir. larger reduct. in
LDL (more than 45%) may be started
at 40 mg 1 x dly. Adjust. dose at
intervals of 4 wks or more. Max. dose:
80 mg 1 x dly. Doses may be given at
any time of day w/o regard to
meals. Lipid levels to be analyzed
within 2-4 wks and dose adjust.
accord. See lit.
F.C. TABS: 30 x 40 mg, 80 mg.
Initial: 10 mg 1 x dly. Incr. grad. to max.
80 mg 1 x dly w/o regard to meals.
Hypercholesterol.:adjunct. to diet for tmt. elevated total
and LDL cholesterol, apo B, triglyc. in pts.
with prim. hypercholesterolem.,
incl. famil. hypercholesterolem. (heterozyg.)
or combined (mixed) hyperlipidemia
(types IIa, IIb Fredrickson classific.) when
resp. to diet and other non-pharm.
meas. alone has been inad. To reduce
total-C and LDL-C in pts. with homozyg.
famil. hypercholesterolem. as adjunct to
other tmts. Ped: 10-17 yrs: Adjunct to diet
to reduce total-C, LDL-C, apo B levels in
boys and postmenarchal girls with
heterozyg. famil. hypercholest. aft.
an adeq. trial of diet ther. with foll.
findings: LDL-C remains ≥ 190 mg/dL or
LDL-C remains ≥ 160 mg/dL with
posit. fam. history of prem. CV dis. or 2
or more other CVD risk factors present.
Prevent. CV and/or cerebrovasc. events
such as MI or stroke. Adjunct to correct.
other risk factors such as hypertens. (in
pts. with 3 or more addit. risk factors
or diabetes with one addit. risk factor).
In pts. with clin. coronary heart dis., for
risk red. of non-fatal MI, of fatal and non-fatal stroke,
for revasculariz. proced. and hospitaliz. for CHF.
Risk red. of angina.
C/I: Ac. liver fail. or decompens. cirrhosis
Hypersens. Hypersens. react., incl. anaphylaxis, angioneurot. edema, erythema multif., Stevens-Johnson syndr. and toxic epid. necrolys. have been reported.
HMG-CoA Reductase Inhibitor, Statin. Atorvastatin (as Calcium) 10, 20, 40, 80 mg. Tabs.: 30 X 10, 20 mg, 40 mg, 80mg.
Usual start. dose :10 mg or 20 mg once/day. Dosage range is 10 to 80 mg once/day. Doses should be individualiz. accord. to baseline LDL-C levels, goal of ther., and ptt. resp. Adjust. should be made at intervals of 4 weeks or more. Max. dose is 80 mg once /day.
After init. and/or upon titr., lipid levels should be analyzed within 2 to 4 weeks and dosage adjust. accord. See lit.
Indic. as adjunct to diet for reduct. of elev. total cholesterol, LDL-cholest., apolipoprotein B and triglycerides and to increase HDL Cholesterol in pts. with primary hypercholesterol. includ. familial hypercholesterol. (heterozygous variant) or combined (mixed) hyperlipidemia (correspond. to types IIa and IIb of the fredrickson classification) when resp. to diet and other non-pharmacol. measures is inadeq.
Also indic. to reduce total-C and LDL-C in pts. with homozygous familial hypercholesterol. as an adjunct to other lipid-lowering tmt. (e.g. LDL apheresis) or if such tmts. are unavailable.
Ped. pts. (10-17 years of age):
indic. as adjunct to diet to reduce total-C, LDL-C and apo B levels in boys and postmenarchal girls 10 to 17 years of age, with heterozygous familial hypercholesterol. if after an adeq. trial of diet ther. the follow. findings are present:
1. LDL-C remains >or = 190 mg/dl or
2. LDL-C remains >or = 160 mg/dl and: there is a posit. family hist. of premature cardiovasc. dis. or two or more other CVD risk factors in the ped. ptt.
Prevent. of CV and/or cerebrovasc. event such as MI or stroke as adjunct to correct. of other risk factors such as hypertens. in pt.s with three or more addit. risk factors or diabetes with one addit. risk factor.
In pts. with clin. evident coron. heart disease, indic. to:
Red. risk of non-fatal MI.
Red. risk of fatal and non-fatal stroke.
Red. the risk for revascular. procedures.
Red. the risk of hospitaliz. for CHF.
Red. the risk of angina.
C/I:
Ac. liver fail. or decompens. cirrhosis.
Hypersens. to atorvastatin or to excipts. Hypersens. reactions, incl. anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndr. and toxic epiderm. necrol. have been reported.
See lit.
Statin. Pravastatin Sodium 10, 20, 40 mg. TABS: 30 x 10 mg, 20 mg,
40 mg. 10-40 mg dly at bedt.
Response within 1-2 wks. Max. effect.
4 wks. Elderly: Initiate at lower dose
and monitor.
Prim. prevent. coron. events: In
hypercholest. pts. to reduce risks of M.I.
revascularizat. and deaths due to CV
causes with no incr. in deaths from non-CV
causes. Second. prevent. CV events: In
hypercholesterolem. pts. incl. prior M.I. to
slow the progress. of coron. atheroscleros.
and reduce the risk of acute coron. events.
In pts. with prev. M.I. to reduce the risk of
recur. M.I., risk of myocard. revasc. proced.,
reduce the risk of stroke or transient
ischem. attacks. In hypercholesterolem.
and mixed dyslipidem. (Frederickson types
lla and llb): As adjunct to diet to reduce
elevat. total cholesterol, LDL - cholesterol
and triglyceride levels.
Statin. Pravastatin Sodium 20 mg, 40 mg. TAB: 30 x 20 mg,
40 mg. Usual dosage range: 10-40
mg dly at bedt. Dose response effect is
apparent within 1-2 wks; Max. effect: 4
wks. Perform periodic lipid determ. at
intervals of not less than 4 wks. and
adjust dosage. Not to be used under 18
yrs of age. Elderly and pts. with hepat.
or ren. impair: Initiate tmt. at the lower
dosage range and monitor pts.
Prim. prevent. coron. events: In
hypercholest. pts. to reduce risks of M.I..
revascularizat. and deaths due to CV causes
with no incr. in deaths from non-CV causes.
Second. prevent. CV events: In
hypercholesterolem. pts. incl. prior M.I. to
slow the progress. of coron. atheroscleros.
and reduce the risk of acute coron. events.
In pts. with prev. M.I. to reduce the risk of recur. M.I., risk of myocard. revasc. proced.,
reduce the risk of stroke or transient ischem.
attacks. In hypercholesterolem. and mixed
dyslipidem. (Frederickson types lla and llb):
As adjunct to diet to reduce elevat. total
cholesterol, LDL - cholesterol and
triglyceride levels.
C/I: Known hypersens. to any ingred.,
pregn., lact.; active liver dis. or
unexplained, persistent elevat. in liver
funct. tests.
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.
