All the Active Ingredient Drugs
Statin. Simvastatin 10, 20, 40, 80 mg. TABS: 30. Coron. heart dis: Initial: 10
mg/ day as single dose in evening.
Dosage adjust. (if necess.): at intervals
of not less than 4 wks., to max. of 40
mg dly as single dose in evening.
Famil. homozygous
hypercholesterolem: 40 mg/day in
even., or 80 mg/ day in 3 div. doses.
See lit.
Adjunct to diet for reduct. of elevated total
and LDL cholesterol, Apo B and TG and to
increase HDL cholesterol in prim.
hypercholesterolem.
(types 11a and 11b)
mixed dyslipidem. and homozygous
familial hypercholesterolem. when
response to diet and other non-pharm.
measures alone has been inad, in pts. with
homozygous familial hypercholesterolem.
Second. prevent. in pts. with
hypercholesterem. and coron. heart dis. to
reduce the risk of total mort. by reduct.
coron. death, reduct. non-fatal M.I., reduct.
risk mycocard. revasc.
C/I: Hypersens. to compon., active liver
dis., unexplained persist. elevation
serum transaminases, pregn., lact. pts.
under 20 yrs., concom. ther. with tetralol
class calc. channel blocker. Not
recommend in pts. under 20 yrs.
Statin. Simvastatin 10, 20, 40, 80 mg. TABS: 30. Coron. heart dis: Initial: 20 mg
dly as single dose in even. Adjust if
reqd. at intervals of not less than 4 wks
to max. of 80 mg dly as single dose.
Homozygous famil.
hypercholesterolem: 40 mg dly in even.
as single dose or 80 mg/day in 3 div.
doses (20 mg, 20 mg and even. dose of
40 mg).
Adjunct to diet for reduct. of elevated total
and LDL cholesterol, Apo B and TG and to
increase HDL cholesterol in prim.
hypercholesterolem.
(types 11a and 11b)
mixed dyslipidem. and homozygous
familial hypercholesterolem. when
response to diet and other non-pharm.
measures alone has been inad, in pts. with
homozygous familial hypercholesterolem.
Second. prevent. in pts. with
hypercholesterem. and coron. heart dis. to
reduce the risk of total mort. by reduct.
coron. death, reduct. non-fatal M.I., reduct.
risk mycocard. revasc.
C/I: Hypersens. to compon., active liver
dis., unexplained persist. elevation
serum transaminases, pregn., lact. pts.
under 20 yrs., concom. ther. with tetralol
class calc. channel blocker. Not
recommend in pts. under 20 yrs.
Statin. Simvastatin 10, 20, 40, 80 mg. CAPLET.: 30. CHD: can be init.
simultaneous. with diet. Usual initial.
is 10- 20 mg/d given as a single dose in
the evening. Lipid profile should be
perform. after 4 wks. of ther.and
periodic. thereafter. Adjust. of dosage,
if requir.should be made at interval. of
not less than 4 wks., to a max. of 80
mg/d. Hypercholesterolaemia: the pt.
should be placed on a standard
cholesterol-low. diet, and should cont.
on this diet during tmt.. The usual init.
dose is 10-20mg/d given as a single
dose in the ev. Pts. who require a large
reduc. in LDL-C (more than 45 %) may
be init. at 20-40 mg/d. given as a single
dose in the ev. Adjust. of dosage, if
required, should be made at interv. of
not less than 4 wks. up to a max. of 80
mg/d. Homozygous famil.
hypercholesterolaemia: 40 mg/d in the
ev. Should be used as an adjunct to
other lipid-low. tmt. (e.g., LDL
apheresis) in these pts. or if such tmts.
are unavail.
Simvastatin exposure is approx.
doubled with concom. use of
lomitapide, therefore the dose of
Simvastatin should be reduced by 50%
if initiat. lomitapide.
Simvastatin dosage should not exceed
20mg/d. (or 40mg/d. for pts. who have
prev. taken Simvastatin 80mg/d.
chronic., e.g. for 12 mnths. or more,
without evidence of muscle toxicity)
while taking lomitapide. Restricted
Dosing for 80 mg: due to incr. risk of
myopathy, includ. rhabdomyolysis,
particul. during the 1st year of tmt.,
use of 80mg dose should be restricted
to pts. who have been taking
simvastatin 80mg chron.(e.g. for 12
mnths. or more) without evidence of
muscle toxic. Pts. who are current.
tolerat. the 80mg dose who need to be
init. on an interact. drug that is
contraindic.or is assoc. with a dose cap
for simvastatin should be switched to
an altern. statin with less potent. for
the drug-drug interact. Due to the incr.
risk of myopathy, include.
rhabdomyolysis, assoc. with the 80mg
dose, pts. unable to achieve their
LDL-C goal utiliz.the 40mg dose
should not be titrat.to 80mg dose, but
should be placed on alternat. LDL-C
low. tmt. that provides greater LDL-C
low. See lit. Concom. ther./ ren.
insuffic./Chinese pts.: See lit.
In pts. with CHD & hypercholesterolemia:
reduce the risk of total mortal.by reduc.
coronary death; reduce the risk of nonfatal
MI; reduce the risk for underg.
myocard. revasculariz. proced. ; reduce the
risk of stroke and TIA’s. Hyperlipidemia: As
adjunct to diet to reduce elevated TOTAL-C
LDL-C Apo B and TG; to incr.HDL-C in pts.
with prim. hypercholesterolemia
(heterozygous famil.and nonfamil.) and
mixed dyslipidem.(Frederickson Types IIa
and IIb), therefore low. the LDL-C/HDL-C,
and the total- C/HDL-C ratios.
Homozygous famil. hypercholesterolemia:
as adjunct to diet and other non-diet.
measures in reduc. elevat. total cholesterol,
LDL-cholesterol, apo-lipoprotein B in pts.
with homozygous famil.
hypercholesterolemia when response to
these measures is inadequate.
Hypertriglyceridemia (Fredrickson type IV
hyperlipidemia). Tmt. of pts. with prim.
dysbetalipoproteinemia (Fredrickson type
III hyperlipidemia).See lit
Simvaxon 80mg is also indic.in pts. at a
high risk of coron. events because of
existing CHD, diabetes, periph. vessel dis.,
history of stroke or other cerebrovas. dis.:
to reduce the risk of total mortal.by reduc.
CHD deaths; reduce the risk of non-fatal MI
&stroke; reduce the need for coron. &noncoron.
revascularizat. proced. See lit
C/I: Hypersens. Pregn., may become
pregnant,lact., hep. impair., act. hep. dis./
unexplain. persist. elevat.of serum
transaminases., co- admin. of potent
CYP3A4 inhib. (e.g. itraconazole,
ketoconazole, posaconazole,
voriconazole, HIV protease inhib. (e.g.
nelfinavir), boceprevir, telaprevir,
erythromycin, clarithromycin,
telithromycin and nefazodone),
co-admin of gemfibrozil, cyclosporin, or
danazol. In pts. with HoFH, concom. admin. of lomitapide with doses >40mg
Simvaxon, See lit.
