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
Questran Indications, Dosage, Storage, Stability - Cholestyramine
Questran Indications, Dosage, Storage, Stability - Cholestyramine
INDICATIONS
1) Cholestyramine for Oral Suspension, USP powder is indicated as adjunctive
therapy to diet for the reduction of elevated serum cholesterol in patients
with primary hypercholesterolemia (elevated low density lipoprotein [LDL]
cholesterol) who do not respond adequately to diet. Cholestyramine for
Oral Suspension, USP powder may be useful to lower LDL cholesterol in
patients who also have hypertriglyceridemia, but it is not indicated where
hypertriglyceridemia is the abnormality of most concern.
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 specific for
the type of hyperlipoproteinemia determined prior to initiation of drug
therapy. Excess body weight may be an important factor and caloric restriction
for weight normalization should be addressed prior to drug therapy in
the overweight.
Prior to initiating therapy with cholestyramine resin, 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 assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals
with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using
the following equation:
LDL-C = Total cholesterol - [( TG/5) + HDL-C]
For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations
should be determined by ultracentrifugation. In hypertriglyceridemic patients,
LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine
resin may not be indicated.
Serum cholesterol and triglyceride levels should be determined periodically
based on NCEP guidelines to confirm initial and adequate long-term response.
A favorable trend in cholesterol reduction should occur during the first
month of cholestyramine resin therapy. The therapy should be continued
to sustain cholesterol reduction. If adequate cholesterol reduction is
not attained, increasing the dosage of cholestyramine resin or adding
other lipid-lowering agents in combination with cholestyramine resin should
be considered.
Since the goal of treatment is to lower LDL-C, the NCEP4 recommends
that LDL-C levels be used to initiate and assess treatment response. If
LDL-C levels are not available then Total-C alone may be used to monitor
long-term therapy. A lipoprotein analysis (including LDL-C determination)
should be carried out once a year. The NCEP treatment guidelines are summarized
below.
| |
|
LDL-Cholesterol
mg/dL (mmol/L)
|
|
Definite
Atherosclerotic
Disease*
|
Two or More
Other Risk
Factors
|
Initiation
Level
|
Goal
|
| NO |
NO |
³190
(³4.9) |
<160
(< 4. 1) |
| NO |
YES |
³160
(³4.1) |
<130
(< 3. 4) |
| YES |
YES or NO |
³130
(³3.4) |
£100
(£2.6) |
*Coronary heart disease or peripheral vascular disease (including symptomatic
carotid artery disease).
** Other risk factors for coronary heart disease (CHD) include: age (males
³45
years; females: ³55
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 ³60
mg/dL (³1.6
mmol/L).
Cholestyramine resin monotherapy has been demonstrated to retard the
rate of progression2,3 and increase the rate of regression3
of coronary atherosclerosis.
2) Cholestyramine for Oral Suspension, USP powder is indicated for the
relief of pruritus associated with partial biliary obstruction. Cholestyramine
resin has been shown to have a variable effect on serum cholesterol in
these patients. Patients with primary biliary cirrhosis may exhibit an
elevated cholesterol as party of their disease.
DOSAGE AND ADMINISTRATION
The recommended starting adult dose for Cholestyramine for Oral Suspension,
USP powder is 1 pouch or 1 level scoopful (9 grams of Cholestyramine for
Oral Suspension, USP powder contains 4 grams of anhydrous cholestyramine
resin) once or twice a day. The recommended maintenance dose for Cholestyramine
for Oral Suspension, USP powder is 2 to 4 pouches of scoopfuls daily (8
to 16 grams anhydrous cholestyramine resin) divided into two doses. It
is recommended that increases in dose be gradual with periodic assessment
of lipid/lipoprotein levels at intervals of not less than 4 weeks. The
maximum recommended daily dose is 6 pouches or scoopfuls of Cholestyramine
for Oral Suspension, USP powder (24 grams of anhydrous cholestyramine
resin) The suggested time of administration is at mealtime but may be
modified to avoid interference with absorption of other medications. Although
the recommended dosing schedule is twice daily, Cholestyramine for Oral
Suspension, USP powder may be administered in 1 to 6 doses per day.
Cholestyramine for Oral Suspension, USP powder should not be taken
in its dry form. Always mix the dry powder with water or other fluids
before ingesting. See Preparation Instructions.
Concomitant Therapy
Preliminary evidence suggests that the lipid-lowering effects of cholestyramine
on total and LDL-cholesterol are enhanced when combined with a HMG-CoA
reductase inhibitor, e.g., pravastatin, lovastatin, simavastatin, and
fluvastatin. Additive effects on LDL-cholesterol are also seen with combined
nicotinic acid/cholestyramine therapy. See the Drug Interactions subsection
of the PRECAUTIONS section for recommendations on administering concomitant
therapy.
Preparation
The color of Cholestyramine for Oral Suspension, USP powder may vary
somewhat from batch to batch but this variation does not affect the performance
of the product. Place the contents of one single-dose pouch or one level
scoopful of Cholestyramine for Oral Suspension, USP powder in a glass
or cup. Add at least 2 to 6 ounces of water or the beverage of your choice.
Stir to a uniform consistency.
Cholestyramine for Oral Suspension, USP powder may also be mixed with
highly fluid soups or pulpy fruits with a high moisture content such as
applesauce or crushed pineapple.
HOW SUPPLIED
Cholestyramine for Oral Suspension, USP powder orange flavor is available
in cartons of sixty 9 gram pouches and in cans containing 378 grams. Nine
grams of Cholestyramine for Oral Suspension, USP powder contain 4 grams
of anhydrous cholestyramine resin.
Carton of 60 pouches
Can, 378 g (containing a scoop that is not interchangeable with scoops
from other products)
Storage: Store at controlled room temperature 15°-30°C (59°-86°F).
Rx only
REFERENCES
1. The Lipid Research Clinics Coronary Primary Prevention
Trial Results: (I) Reduction in Incidence of Coronary Heart Disease; (II)
The Relationship of Reduction in Incidence of Coronary Heart Disease to
Cholesterol Lowering. JAMA. 1984;251:351-374
2. Brensike JF, Levy RI, Kelsey SF, et al. Effects of
therapy with cholestyramine on progression of coronary arteriosclerosis:
results of the NHLBI type II coronary intervention study. Circulation
1984; 69:313-24.
3. Watts GF, Lewis B, Brunt JNH, Lewis ES, et al. Effects
on coronary artery disease of lipid lowering diet or diet plus cholestyramine,
in the St. Thomas Atherosclerosis Regression Study (STARS). Lancet
1992; 339:563-89.
4. National Cholesterol Education Program. Second Report
of the Expert Panel on Detection, Evaluation, and Treatment of High Blood
Cholesterol in Adults (Adult Treatment Panel II). Circulation 1994
Mar;89 (3):1933-445.
5. The Lipid Research Clinics Investigators. The Lipid
Research Clinics Coronary Primary Prevention Trial Results of 6 Years
of Post-Trial Follow-up. Arch Intern Med 1992; 152:1399-1410.
6. Behrman RE et al (eds): Nelson, Textbook of Pediatrics,
ed 15. Philadelphia, PA, WB Saunders Company, 1996.
7. Takemoto CK et al (eds): Pediatric Dosage Handbook,
ed 3. Cleveland/Akron, OH, Lexi-Comp, Inc., 1996/1997.
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