A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lescol Indications, Dosage, Storage, Stability - Fluvastatin sodium
Lescol Indications, Dosage, Storage, Stability - Fluvastatin sodium
INDICATIONS
AND USAGE
Therapy with lipid-altering agents should be a component of
multiple risk factor intervention in those individuals at significantly increased
risk for atherosclerosis vascular disease due to hypercholesterolemia.
Hypercholesterolemia (heterozygous familial and non familial)
and Mixed Dyslipidemia
Lescol® (fluvastatin sodium) and Lescol®
XL (fluvastatin sodium) are indicated as an adjunct to diet to reduce elevated
total cholesterol (Total-C), LDL-C, TG and Apo B levels, and to increase HDL-C
in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson
Type IIa and IIb) whose response to dietary restriction of saturated fat and
cholesterol and other nonpharmacological measures has not been adequate.
Atherosclerosis
Lescol and Lescol XL are also indicated to slow the progression
of coronary atherosclerosis in patients with coronary heart disease as part
of a treatment strategy to lower total and LDL cholesterol to target levels.
Therapy with lipid-altering agents should be considered only
after secondary causes for hyperlipidemia such as poorly controlled diabetes
mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver
disease, other medication, or alcoholism, have been excluded. Prior to initiation
of fluvastatin sodium, a lipid profile should be performed to measure Total-C,
HDL-C and TG. For patients with TG <400 mg/dL (<4.5 mmol/L), LDL-C can
be estimated using the following equation: LDL-C = Total-C - HDL-C - 1/5 TG
For TG levels >400 mg/dL (>4.5 mmol/L), this equation
is less accurate and LDL-C concentrations should be determined by ultracentrifugation.
In many hypertriglyceridemic patients LDL-C may be low or normal despite elevated
Total-C. In such cases, Lescol is not indicated.
Lipid determinations should be performed at intervals of no
less than 4 weeks and dosage adjusted according to the patient s response to
therapy.
The National Cholesterol Education Program (NCEP) Treatment
Guidelines are summarized below:
|
Table 3 : NCEP Treatment Guidelines: LDL-C Goals and Cutpoints
for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
|
|
Risk Category
|
LDL Goal
(mg/dL)
|
LDL Level at Which to Initiate Therapeutic Lifestyle Changes
(mg/dL)
|
LDL Level at Which to Consider Drug Therapy
(mg/dL)
|
|
CHD † or CHD risk equivalents
(10-year risk >20%)
|
<100
|
³ 100
|
³ 130
(100-129: drug optional) †
|
|
2+ Risk factors
(10-year risk £ 20%)
|
<130
|
³ 130
|
10-year risk 10%-20%: ³
130
10-year risk <10%: ³
160
|
|
0-1 Risk factor †††
|
<160
|
³ 160
|
³ 190
(160-189: LDL-lowering
drug optional)
|
|
†CHD, coronary heart disease
|
|
††Some authorities recommend use of LDL-lowering drugs
in this category if an LDL-C level of <100mg/Dl cannot be achieved
by therapeutic lifestyle changes. Others prefer use of drugs that primarily
modify triglycerides and HDL-C, e.g. nicotinic acid or fibrate. Clinical
judgement also may call for deferring drug therapy in this subcategory.
|
|
††† Almost all people with 0-1 risk factor have 10-year
risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor
is not necessary.
|
After the LDL-C goal has been achieved, if the TG is still
³ 200 mg/dL, non-HDL-C (total-C minus HDL-C)
becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher
than LDL-C goals for each risk category.
At the time of hospitalization for an acute coronary event,
consideration can be given to initiating drug therapy at discharge if the LDL-C
level is ³ 130 mg/dL (NCEP-ATP II).
Since the goal of treatment is to lower LDL-C, the NCEP recommends
that the LDL-C levels be used to initiate and assess treatment response. Only
if LDL-C levels are not available, should the Total-C be used to monitor therapy.
|
Table 4 : Classification of Hyperlipoproteinemias
|
|
Type
|
Lipoproteins
Elevated
|
Lipid Elevations
|
|
Major
|
Minor
|
|
I (rare)
|
Chylomicrons
|
TG
|
® C
|
|
IIa
|
LDL
|
C
|
-
|
|
IIb
|
LDL, VLDL
|
C
|
TG
|
|
III (rare)
|
IDL
|
C/TG
|
-
|
|
IV
|
VLDL
|
TG
|
® C
|
|
V (rare)
|
Chylomicrons, VLDL
|
TG
|
® C
|
|
C = cholesterol, TG = triglycerides, LDL = low density
lipoprotein, VLDL = very low density lipoprotein,
|
|
IDL = intermediate density lipoprotein
|
Neither Lescol nor Lescol XL have been studied in conditions
where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e.,
hyperlipoproteinemia Types I, III, IV, or V).
DOSAGE AND ADMINISTRATION
The patient should be placed on a standard cholesterol-lowering
diet before receiving Lescol® (fluvastatin sodium) or Lescol®
XL (fluvastatin sodium) and should continue on this diet during treatment with
Lescol or Lescol XL. (See NCEP Treatment Guidelines for details on dietary therapy.)
For patients requiring LDL-C reduction to a goal of =25%, the recommended starting
dose is 40 mg as one capsule, 80 mg as one Lescol XL tablet administered as
a single dose in the evening or 80 mg in divided doses of the 40 mg capsule
given twice daily. For patients requiring LDL-C reduction to a goal of <25%
a starting dose of 20 mg may be used. The recommended dosing range is 20-80
mg/day. Lescol or Lescol XL may be taken without regard to meals, since there
are no apparent differences in the lipid-lowering effects of fluvastatin sodium
administered with the evening meal or 4 hours after the evening meal. Since
the maximal reductions in LDL-C of a given dose are seen within 4 weeks, periodic
lipid determinations should be performed and dosage adjustment made according
to the patient s response to therapy and established treatment guidelines. The
therapeutic effect of Lescol or Lescol XL is maintained with prolonged administration.
Concomitant Therapy
Lipid-lowering effects on total cholesterol and LDL cholesterol
are additive when immediate release Lescol is combined with a bile-acid binding
resin or niacin. When administering a bile-acid resin (e.g., cholestyramine)
and fluvastatin sodium, Lescol should be administered at bedtime, at least 2
hours following the resin to avoid a significant interaction due to drug binding
to resin. (See also ADVERSE REACTIONS:
Concomitant Therapy.)
Dosage in Patients with Renal Insufficiency
Since fluvastatin sodium is cleared hepatically with less than
6% of the administered dose excreted into the urine, dose adjustments for mild
to moderate renal impairment are not necessary. Fluvastatin has not been studied
at doses greater than 40 mg in patients with severe renal impairment; therefore
caution should be exercised when treating such patients at higher doses.
HOW SUPPLIED
Lescol® (fluvastatin sodium) Capsules
20 mg
Brown and light brown imprinted twice with and 20 on one
half and LESCOL and the Lescol® (fluvastatin sodium) logo twice
on the other half of the capsule.
Bottles of 30 capsules........................................................................(NDC
0078-0176-15)
Bottles of 100 capsules......................................................................(NDC
0078-0176-05)
40 mg
Brown and gold imprinted twice with and 40 on one half
and LESCOL and the Lescol® (fluvastatin sodium) logo twice on
the other half of the capsule.
Bottles of 30 capsules........................................................................(NDC
0078-0234-15)
Bottles of 100 capsules......................................................................(NDC
0078-0234-05)
Lescol® XL (fluvastatin sodium) Extended-Release
Tablets
80 mg
Yellow, round, slightly biconvex film-coated tablet with beveled
edges debossed with Lescol XL on one side and 80 on the other.
Bottles of 30 tablets...........................................................................(NDC
0078-0354-15)
Bottle of 100 tablets...........................................................................(NDC
0078-0354-05)
Store and Dispense
Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF).
[See USP Controlled Room Temperature]. Dispense in a tight container. Protect
from light.
*Trademark of Medical Economics Company, Inc.
Distributed by: Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
T2001-78 REV: OCTOBER 2001 Printed in U.S.A.
89011104, © 2001 Novartis
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