INDICATIONS
Since no drug is innocuous, strict attention
should be paid to the indications and contraindications,
particularly when selecting drugs for chronic long-term
use.
COLESTID Tablets are indicated as adjunctive therapy
to diet for the reduction of elevated serum total and
LDL-C in patients with primary hypercholesterolemia (elevated
LDL-C) who do not respond adequately to diet. Generally,
COLESTID Tablets have no clinically significant effect
on serum triglycerides, but with their use, triglyceride
levels may be raised in some patients.
Therapy with lipid-altering agents should be a component
of multiple risk factor intervention in those individuals
at significantly increased risk for atherosclerotic vascular
disease due to hypercholesterolemia. Treatment should
begin and continue with dietary therapy (see NCEP guidelines).
A minimum of six months of intensive dietary therapy and
counseling should be carried out prior to initiation of
drug therapy. Shorter periods may be considered in patients
with severe elevations of LDL-C or with definite CHD.
According to the NCEP guidelines, the goal of treatment
is to lower LDL-C, and LDL-C is to 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.
The NCEP treatment guidelines are shown below.
Definite
Atherosclerotic
Disease* |
Two or More
Other Risk
Factors** |
Initiation
Level |
Goal |
|
No |
No |
2190
(24.9) |
<160
(<4.1) |
|
No |
Yes |
2160
(24.1) |
<130
(<3.4) |
|
Yes |
Yes or No |
2130
(>3.4) |
<100
(52.6) |
*Coronary heart disease or peripheral vascular disease
(including symptomatic carotid artery disease).
** Other risk factors for coronary heart disease (CHD)
include: age (males: >45 years; female: >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
factor if HDL-C is >60 mg/dL (1.6 mmol/L).
DOSAGE AND ADMINISTRATION
For adults, COLESTlD Tablets are recommended in doses
of 2 to 16 grams/day given once or in divided doses. The
starting dose should be 2 grams once or twice daily. Dosage
increases of 2 grams, once or twice daily should occur
at 1- or 2-month intervals. Appropriate use of lipid profiles
as per NCEP guidelines including LDL-C and triglycerides,
is advised so that optimal but not excessive doses are
used to obtain the desired therapeutic effect on LDL-C
level. If the desired therapeutic effect is not obtained
at a dose of 2 to 16 grams/day with good compliance and
acceptable side effects, combined therapy or alternate
treatment should be considered. COLESTID Tablets must
be taken one at a time and be promptly swallowed whole,
using plenty of water or other appropriate liquid. Do
not cut, crush, or chew the tablets. Patients should take
other drugs at least one hour before or four hours after
COLESTID Tablets to minimize possible interference with
their absorption. (See DRUG INTERACTIONS.)
Before Administration of COLESTID Tablets
- Define the type of hyperlipoproteinemia, as described
in NCEP guidelines.
- Institute a trial of diet and weight reduction.
- Establish baseline serum total and LDL-C and triglyceride
levels.
During Administration of COLESTID Tablets
- The patient should be carefully monitored clinically,
including serum cholesterol and triglyceride levels.
Periodic determinations of serum cholesterol levels
as outlined in the NCEP guidelines should be done to
confirm a favorable initial and long-term response.
- Failure of total or LDL-C to fall within the desired
range should lead one to first examine dietary and drug
compliance. If these are deemed acceptable, combined
therapy or alternate treatment should be considered.
- Significant rise in triglyceride level should be considered
as indication for dose reduction, drug discontinuation,
or combined or alternate therapy.
HOW SUPPLIED
COLESTID Tablets are yellow, elliptical, imprinted U,
and are supplied as follows:
COLESTID Tablets are yellow, elliptical, imprinted U,
and are supplied as follows:
- Bottles of 120 .....................NDC 0009-0450-03
- Bottles of 500 .....................NDC 0009-0450-04
Each tablet contains 1 gram of colestipol hydrochloride.
Store at controlled room temperature 20° to 25°
C (68° to 77° F) [see USP].
REFERENCES
- Summary of the Second Report of the National Cholesterol
Education Program (NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol
in Adults (Adult Treatment Panel II). JAMA 1993; 269(23):
3015-3023.
- Lipid Metabolism-Atherogenesis Branch, National Heart,
Lung, and Blood institute, Bethesda, MD: The Lipid Research
Clinics Coronary Primary Prevention Trial Results. I.
Reduction in Incidence of Coronary Heart Disease. JAMA
1984; 251:351-364.
- Parra HJ, et al. Differential electroimmunoassay of
human LpA-I lipoprotein particles on ready-to-use plates.
Clin. Chem. 1990; 36(8): 1431-l 435.
- Barbaras R, et al. Cholesterol efflux from cultured
adipose cells is mediated by LpAI particles but not
by LpAI:AII particles. Biochem. Biophys. Res. Comm.
1987; 142( 1):63-69.
- Kane JP, et al. Normalization of low-density-lipoprotein
levels in heterozygous familial hypercholesterolemia
with a combined drug regimen. N Engl. J. Med. 1981;
304:251-258.
- Illingworth DR, et al. Colestipol plus nicotinic acid
in treatment of heterozygous familial hypercholesterolemia.
Lancet 1981; 1:296-298.
- Kuo PT, et al. Familial type II hyperlipoproteinemia
with coronary heart disease: Effect of diet-colestipol-
nicotinic acid treatment. Chest 1981; 79:286-291.
- Blankenhorn DH, et al. Beneficial Effects of Combined
Colestipol-Niacin Therapy on Coronary Atherosclerosis
and Coronary Venous Bypass Grafts. JAMA 1987; 257(23):3233-3240
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