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1
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
LESCOL/LESCOL XL
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist.
LESCOL/LESCOL XL has been prescribed for you personally and you should
not
share your medicine with other people. It may harm them, even if their
symptoms
are the same as yours.
_ _
SCHEDULING STATUS
S4
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_ _
PROPRIETARY NAME AND DOSAGE FORM
:
LESCOL
® 20 MG CAPSULE
LESCOL
® 40 MG CAPSULE
LESCOL XL
® FILM-COATED TABLET
Fluvastatin sodium
1.
WHAT LESCOL/LESCOL XL CONTAINS_ _
_ _
The ACTIVE SUBSTANCE of Lescol capsules and Lescol XL tablets is
fluvastatin
sodium.
The OTHER INGREDIENTS of Lescol capsules are: magnesium stearate,
sodium
hydrogen
carbonate,
talc,
cellulose
microcrystalline,
maize
starch,
calcium
carbonate, gelatin, iron oxide red and yellow, titanium dioxide,
shellac.
2
_ _
The
OTHER
ingredients
of
Lescol
XL
tablets
are:
cellulose
microcrystalline,
hypromellose, hydroxypropyl cellulose, potassium hydrogen carbonate,
povidone,
magnesium stearate, iron oxide yellow, titanium dioxide, macrogol 8000
.
_ _
2.
WHAT LESCOL/LESCOL XL IS USED FOR
Each Lescol 20 mg capsule contains 21,06 mg fluvastatin sodium
equivalent to 20 mg
fluvastatin free acid.
Each Lescol 40 mg capsule contains 42,12 mg fluvastatin sodium
equivalent to 40 mg
fluvastatin free acid.
Each Lescol XL 80 mg tablet contains 84,24 mg fluvastatin sodium
equivalent to 80 mg
fluvastatin free acid.Adults and children/adolescents (aged 9 years
and older).
_ _
_Adults: _
LESCOL/LESCOL XL is indicated as an add-on to diet for the reduction
of elevated
“bad” cholesterol and for the increase of “good” cholesterol.
Lescol/Lescol XL also slows the progression of coronary
atherosclerosis.
_Paediatric population: _
LESCOL/LESCOL XL is indicated as an add-on to diet for the reduction
of elevated
“bad” cholesterol in children and adolescents aged 9 years and
older with
heterozygous familial hypercholesterolaemia.
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製品の特徴
1
SCHEDULING STATUS S4
PROPRIETARY NAMES AND DOSAGE FORMS
LESCOL
® 20 MG CAPSULE
LESCOL
® 40 MG CAPSULE
LESCOL XL
® FILM-COATED TABLET
COMPOSITION
LESCOL 20 mg:
Each capsule contains 20 mg fluvastatin as fluvastatin sodium.
LESCOL 40 mg:
Each capsule contains 40 mg fluvastatin as fluvastatin sodium.
LESCOL XL:
Each tablet contains 80 mg fluvastatin as fluvastatin sodium.
PHARMACOLOGICAL CLASSIFICATION
A 7.5 Serum-cholesterol reducers.
PHARMACOLOGICAL ACTION
Fluvastatin, a fully synthetic cholesterol-lowering agent, is a
competitive inhibitor of HMG–CoA
reductase, which is responsible for the conversion of HMG–CoA to
mevalonate, a precursor of
sterols, including cholesterol. Fluvastatin exerts its main effect in
the liver and is mainly a racemate
of the two erythro enantiomers of which one exerts the pharmacological
activity. The inhibition of
cholesterol biosynthesis reduces the cholesterol in hepatic cells,
which stimulates the synthesis of
LDL receptors and thereby increases the uptake of LDL particles. The
ultimate results of these
mechanisms are a reduction of the plasma cholesterol concentration.
In patients with hypercholesterolemia, treatment with LESCOL/LESCOL XL
reduced total-C, LDL-C
and apo-lipoprotein B. Fluvastatin also variably reduces triglycerides
whereas an increase in HDL-
C is modest and variable.
PHARMACOKINETICS:
_Absorption: _
Fluvastatin is absorbed rapidly and completely (98 %) after oral
administration of a solution to
fasted volunteers. The absolute oral bioavailability assessed from
systemic blood concentrations is
24 % for the LESCOL capsules. The systemic exposure with LESCOL XL 80
was approximately 25
% lower to that of the capsules. After oral administration of LESCOL
XL 80, and in comparison with
the capsules, the absorption rate of fluvastatin is about 60 % slower
compared to LESCOL
capsules while the mean residence time of fluvastatin is increased by
approximately 4 hours. In fed
state, the drug is absorbed at a reduced rate.
_Distribution: _
Fluvastatin exerts its main ef
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