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
Baycol Indications, Dosage, Storage, Stability - Cerivastatin
Baycol Indications, Dosage, Storage, Stability - Cerivastatin
INDICATIONS
Therapy with lipid- altering drugs should be a component
of multiple risk factor
intervention in
those patients at significantly high risk
for atherosclerotic vascular
disease due to hypercholesterolemia.
BAYCOL (cerivastatin sodium tablets) is indicated as an adjunct
to diet for the reduction
of elevated total and LDL
cholesterol levels
in patients with primary
hypercholesterolemia and mixed
dyslipidemia (Fredrickson Types IIa and IIb) when the response to
dietary restriction
of saturated fat
and cholesterol
and other non-pharmacological measures alone has been inadequate.
Before considering therapy
with lipid- altering agents, secondary
causes of hypercholesterolemia,
e.g., poorly controlled diabetes
mellitus, hypothyroidism, nephrotic syndrome,
dysproteinemias, obstructive liver
disease, other drug
therapy, alcoholism,
should be excluded and a lipid profile
performed to measure Total-C, HDL-C, and TRIGLYCERIDES (TG). For
patients with TG less than 400 mg/dL, LDL-C can be estimated using
the following equation:
LDL-C = [Total-C] minus [HDL-C + TG/5]
for TG levels > 400 mg/dL, this equation
is less accurate and LDL-C concentrations should be directly
measured by preparative ultracentrifugation. In many hypertriglyceridemic
patients, LDL-C may be low or normal
despite elevated Total-C. In
such cases, BAYCOL (cerivastatin
sodium tablets) is not
indicated.
Lipid determinations should be performed at intervals of no
less than four weeks.
The National Cholesterol Education Program (NCEP) Treatment Guidelines
are summarized in Table 2.
Table 2
|
National Cholesterol Education Program
(NCEP)
Treatment Guidelines
|
| |
LDL-Cholesterol |
mgML (mmol/L) |
|
| Definite
Atherosclerotic Disease*
|
Two or More Other Risk Factors**
|
Initiatio
Level***
|
Goal |
| NO |
NO |
³
190 ( ³ 4.9) |
<160 (< 4.1) |
| NO |
YES |
³
160 ( ³ 4.1) |
<130 (< 3.4) |
| YES |
YES or NO |
³
130 ( ³ 3.4) |
<100 (< 2.6) |
| * Coronary
heart disease
or peripheral
vascular disease
(including symptomatic
carotid artery disease).
** Other risk
factors for coronary heart disease
(CHD) include the following: age
males: ³ 45 years:
females: ³ 55 years or premature
menopause
without estrogen
replacement
therapy); family history
of premature
CHD; current
cigarette smoking; hypertension; confirmed HDL- C < 35
mg/dL < 0.91 mmol/ L), and diabetes
mellitus. Subtract one risk
actor if HDL- C is ³ 60
3’ mg/ dL (³ 1.6 mmol/ L).
*** In CHD
patients with LDL- C levels 100- l29 mg/dL, the physician
should exercise
clinical judgement in deciding whether to
initiate drug treatment
|
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 >/=130 mg/dL (NCEP-ATP II). Since the goal
of treatment is to
lower LDL-C, the NCEP recommends that 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. Although BAYCOL may be useful to reduce elevated LDL-cholesterol
levels in patients with combined hypercholesterolemia and hypertriglyceridemia
where hypercholesterolemia
is the major abnormality (Type Ilb hyperlipoproteinemia), it has
not 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
cholesterollowering diet before receiving cerivastatin sodium
and should continue on this diet
during treatment with cerivastatin sodium. (See NCEP Treatment Guidelines
for details on dietary
therapy.)
The recommended dose is
0.3 mg once daily in the
evening. Cerivastatin sodium may be taken with or without food.
The recommended starting dose in patients with significant
renal impairment
(creatinine clearance
160 mL/min/1.73m2) is 0.2 mg
once daily in the evening.
Since the maximal effect
of cerivastatin sodium
is seen within 4 weeks, lipid determinations should be performed
at this time.
Concomitant Therapy
The lipid-lowering effects on LDL-C and Total-C are additive
when cerivastatin sodium is combined with a bile
acid-binding resin. When coadministering cerivastatin sodium
and a bile- acidexchange resin, e.g., cholestyramine, cerivastatin
sodium should be given
at least 2 hours after the resin
(See also ADVERSE REACTIONS:
Concomitant Therapy).
Dosage in Patients with Renal Insufficiency
No dose adjustment
is necessary for patients with mild renal
dysfunction (Clcr 61-90 mL/min/l.73m2). For patients
with moderate or severe renal dysfunction, a starting dose
of 0.2 mg is recommended
(see CLINICAL PHARMACOLOGY
- Special Populations - Renal).
HOW SUPPLIED
|
Strength
|
Color
|
Markings
|
| |
|
Front |
Back |
| 0.2 mg |
light yellow |
283 |
200 MCG |
| 0.3 mg |
yellow brown |
284 |
300 MCG |
| BAYCOL (cerivastatin
sodium tablets) is supplied as follows: |
| Bottles
of 100: |
0.2 mg
(NDC 0026- 2883- 51) |
| 0.3 mg
(NDC 0026- 2884- 51) |
The tablets should be protected from moisture and stored below
77° F (25° C).
Dispense in tight containers.
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