All the Active Ingredient Drugs
HMG-CoA Reductase Inhibitor, Lipid Modifying Agent. Ezetimibe 10 mg, Atorvastatin 10, 20, 40, 80 mg. F.C. TABS.: 30. Hypercholesterolaemia and/or CHD with ACS History). The pt. should be on an appropriate lipid-lower. diet and should cont. on this diet during tmt. with this drug.
The dose range is 10/10 mg/d. through 10/80 mg/d. The typical dose is 10/10 mg ×1/d. The pt’s. low-density lipoprotein cholesterol (LDL-C) level, CHD status, and response to current cholesterol-lower. ther. should be consid. when starting ther. or adjust. the dose.
The dose should be individual. based on the known efficacy of the various dose strengths of and the response to the current cholesterol-lower. ther. Adjust. of dose should be made at intervals of 4 wks. or more.
HoFH: 10/10-10/80 mg dly. The drug may be used as an adjunct to other lipid-lower. tmts. (e.g., LDL apheresis) in these pts. or if such tms. are unavailab.
May be taken with/without food.
Prevent. of Cardiovasc. Event: Indicat. to reduce the risk of cardiovasc. events in pts. with coron. heart dis.(CHD) and a hist. of acute coron. syndr. (ACS), either previous. treated with a statin or not.
Hypercholesterolaemia: The drug indicat. as adjunct. ther. to diet for use in adult. with prim. (heterozygous famil. and non-famil.) hypercholesterolaemia or mixed hyperlipidaemia where use of a comb. product is appropriate, pts. not appropriat. control. with a statin alone, pts. already treated with a statin and ezetimibe.
Homozyg. Familial Hypercholesterolaemia (HoFH): Indicat. as adjunct. ther. to diet for use in adults with HoFH. Pts. may also receive adjunct. tmts. (e.g., low-density lipoprotein [LDL] apheresis).
C/I: Hypersens. Preg., lact. , and in women of child-bear. potent.
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. Atorvastatin 10, 20, 40, 80 mg. 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 without regard to meals. Lipid
levels should be analyzed within 2-4
wks and dose adjust. accord. See lit.
TABS: 30 x 40 mg, 80 mg.
Initial: 10 mg 1 x dly. Incr. grad. to max.
80 mg 1 x dly without regard to meals.
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
response to diet and other non-pharm.
measures 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. hypercholesterem. aft. an
adequate trial of diet ther. with foll.
findings: LDL-C remains ≥ 190 mg/dL or
LDL-C remains ≥ 160 mg/dL with positive
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
additional risk factors or diabetes with one
additional risk factor.)
C/I: Hypersens.
Active liver dis., unexplained elevat. serum transaminase.
Myopathy.
Pregn, lact.
Concom. use with yclosporine, telaprevir (hepatitis C tmt.) or a comb with tipranavir, ritonavir (HIV tmt.).