Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1416
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QUESTRAN (Powder, For Suspension)
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The recommended starting adult dose for all QUESTRAN powdered
products (QUESTRAN Powder and QUESTRAN LIGHT) is one packet or one level
scoopful once or twice a day. The recommended maintenance dose for all
QUESTRAN powered products is 2 to 4 packets or scoopfuls daily (8-16
grams anhydrous cholestyramine resin) divided into two doses. Four grams
of anhydrous cholestyramine resin is contained in each measured dose of
QUESTRAN as follows: 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 six packets or scoopfuls of
QUESTRAN (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, QUESTRAN may be administered
in 1���6 doses per day. QUESTRAN should not be taken in its dry form.
Always mix QUESTRAN with water or other fluids before ingesting. SeePreparation
Instructions.<br/>Concomitant Therapy: Preliminary evidence suggests that the lipid-lowering
effects of QUESTRAN on total and LDL-cholesterol are enhanced
when combined with a HMG-CoA reductase inhibitor, e.g., pravastatin, lovastatin, simvastatin, and fluvastatin. Additive
effects on LDL-cholesterol are also seen with combined nicotinic acid/QUESTRAN therapy. See the Drug Interactions subsection of the PRECAUTIONS section for recommendations on
administering concomitant therapy.<br/>PREPARATION: The color of QUESTRAN 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 packet or one
level scoopful of QUESTRAN in a glass or cup. Add an amount of
water or other non-carbonated beverage of your choice depending
on the product being used: Stir to uniform consistency and drink. QUESTRAN may also be mixed with highly fluid soups or
pulpy fruits with a high moisture content such as applesauce or
crushed pineapple.
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QUESTRAN' (Cholestyramine for Oral Suspension, USP), the
chloride salt of a basic anion exchange resin, a cholesterol lowering
agent, is intended for oral administration. Cholestyramine resin is
quite hydrophilic, but insoluble in water. The cholestyramine resin in
QUESTRAN is not absorbed from the digestive tract. Four grams of
anhydrous cholestyramine resin is contained in 9 grams of QUESTRAN
POWDER. Four grams of anhydrous cholestyramine resin is contained in 6.4
grams of QUESTRAN LIGHT. It is represented by the following structural
formula: Representation of structure of main polymeric groups QUESTRAN POWDER contains the following inactive ingredients:
acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No.
6, flavor (natural and artificial), polysorbate 80, propylene glycol
alginate, and sucrose (421 mg/g powder). QUESTRAN LIGHT (Orange Vanilla)
contains the following inactive ingredients: aspartame, citric acid USP
anhydrous, D&C Yellow No. 10, FD&C Yellow No. 6, flavors
(natural and artificial Orange, natural and artificial Vanilla Cream),
maltodextrin, magnesium sulfate USP heptahydrate, propylene glycol
alginate, colloidal silicon dioxide, and xanthan gum.
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QUESTRAN is contraindicated in patients with complete biliary
obstruction where bile is not secreted into the intestine and in those
individuals who have shown hypersensitivity to any of its
components.
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QUESTRAN' Powder (Cholestyramine for Oral Suspension,
USP) is available in cartons of sixty 9-gram packets. Four grams of
anhydrous cholestyramine resin are contained in 9 grams of QUESTRAN
Powder. NDC 49884-791-65 Cartons of 60, single dose packets NDC 49884-791-66 Cans, 378 grams QUESTRAN' LIGHT (Cholestyramine for Oral Suspension) is
available in cartons of sixty 6.4-gram packets. Four grams of anhydrous
cholestyramine resin are contained in 6.4 grams of QUESTRAN LIGHT. NDC 49884-792-65 Cartons of 60, single dose packets NDC 49884-792-89 Cans, 268 grams<br/>Storage: Store at room temperature.
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dailymed-instance:inactiveI... |
dailymed-ingredient:D&C_Yellow_No._10,
dailymed-ingredient:FD&C_Yellow_No._6,
dailymed-ingredient:acacia,
dailymed-ingredient:citric_acid,
dailymed-ingredient:flavor_(natural_and_artificial),
dailymed-ingredient:polysorbate_80,
dailymed-ingredient:propylene_glycol_alginate,
dailymed-ingredient:sucrose
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dailymed-instance:precautio... |
General: Chronic use of QUESTRAN may be associated with increased
bleeding tendency due to hypoprothrombinemia associated with
Vitamin K deficiency. This will usually respond promptly to
parenteral Vitamin Kand recurrences can be
prevented by oral administration of Vitamin K.
Reduction of serum or red cell folate has been reported over
long term administration of QUESTRAN. Supplementation with folic
acid should be considered in these cases. There is a possibility that prolonged use of QUESTRAN,
since it is a chloride form of anion exchange resin, may produce
hyperchloremic acidosis. This would especially be true in
younger and smaller patients where the relative dosage may be
higher. Caution should also be exercised in patients with renal
insufficiency or volume depletion, and in patients receiving
concomitant spironolactone. QUESTRAN may produce or worsen pre-existing constipation.
The dosage should be increased gradually in patients to minimize
the risk of developing fecal impaction. In patients with
pre-existing constipation, the starting dose should be 1 packet
or 1 scoop once daily for 5���7 days, increasing to twice daily
with monitoring of constipation and of serum lipoproteins, at
least twice, 4���6 weeks apart. Increased fluid intake and fiber
intake should be encouraged to alleviate constipation and a
stool softener may occasionally be indicated. If the initial
dose is well tolerated, the dose may be increased as needed by
one dose/day (at monthly intervals) with periodic monitoring of
serum lipoproteins. If constipation worsens or the desired
therapeutic response is not achieved at one to six doses/day,
combination therapy or alternate therapy should be considered.
Particular effort should be made to avoid constipation in
patients with symptomatic coronary artery disease. Constipation
associated with QUESTRAN may aggravate hemorrhoids.<br/>Information for Patients: Inform your physician if you are pregnant or plan to
become pregnant or are breastfeeding. Drink plenty of fluids and
mix each 9-gram dose of QUESTRAN POWDER in at least 2 to 6
ounces of fluid. Mix each 6.4 gram dose of QUESTRAN LIGHT in at
least 4 to 6 ounces of fluid before taking. Sipping or holding
the resin suspension in the mouth for prolonged periods may lead
to changes in the surface of the teeth resulting in
discoloration, erosion of enamel or decay; good oral hygiene
should be maintained.<br/>Laboratory Tests: Serum cholesterol levels should be determined frequently
during the first few months of therapy and periodically
thereafter. Serum triglyceride levels should be measured
periodically to detect whether significant changes have
occurred. The LRC-CPPT showed a dose-related increase in serum
triglycerides of 10.7%���17.1% in the cholestyramine-treated
group, compared with an increase of 7.9%���11.7% in the placebo
group. Based on the mean values and adjusting for the placebo
group, the cholestyramine-treated group showed an increase of 5%
over pre-entry levels the first year of the study and an
increase of 4.3% the seventh year.<br/>Drug Interactions: QUESTRAN (Cholestyramine for Oral Suspension, USP) may
delay or reduce the absorption of concomitant oral medication
such as phenylbutazone, warfarin, thiazide diuretics (acidic),
or propranolol (basic), as well as tetracycline, penicillin G,
phenobarbital, thyroid and thyroxine preparations, estrogens and
progestins, and digitalis. Interference with the absorption of
oral phosphate supplements has been observed with another
positively-charged bile acid sequestrant. QUESTRAN may interfere
with the pharmacokinetics of drugs that undergo enterohepatic
circulation. The discontinuance of QUESTRAN could pose a hazard
to health if a potentially toxic drug such as digitalis has been
titrated to a maintenance level while the patient was taking
QUESTRAN. Because cholestyramine binds bile acids, QUESTRAN may
interfere with normal fat digestion and absorption and thus may
prevent absorption of fat-soluble vitamins such as A, D, E and
K. When QUESTRAN is given for long periods of time, concomitant
supplementation with water-miscible (or parenteral) forms of
fat-soluble vitamins should be considered. SINCE QUESTRAN MAY BIND OTHER DRUGS
GIVEN CONCURRENTLY, IT IS RECOMMENDED THAT PATIENTS TAKE
OTHER DRUGS AT LEAST ONE HOUR BEFORE OR 4 TO 6 HOURS AFTER QUESTRAN (OR AT AS GREAT AN INTERVAL
AS POSSIBLE) TO AVOID IMPEDING THEIR ABSORPTION.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: In studies conducted in rats in which cholestyramine
resin was used as a tool to investigate the role of various
intestinal factors, such as fat, bile salts and microbial flora,
in the development of intestinal tumors induced by potent
carcinogens, the incidence of such tumors was observed to be
greater in cholestyramine resin-treated rats than in control
rats. The relevance of this laboratory observation from studies in rats to the clinical use of QUESTRAN is not known. In the
LRC-CPPT study referred to above, the total incidence of fatal
and nonfatal neoplasms was similar in both treatment groups.
When the many different categories of tumors are examined,
various alimentary system cancers were somewhat more prevalent
in the cholestyramine group. The small numbers and the multiple
categories prevent conclusions from being drawn. However, in
view of the fact that cholestyramine resin is confined to the GI
tract and not absorbed, and in light of the animal experiments
referred to above, a six-year post-trial follow-up of the
LRC-CPPT5 patient population has been completed (a total of 13.4
years of in-trial plus post-trial follow-up) and revealed no
significant difference in the incidence of cause-specific
mortality or cancer morbidity between cholestyramine and placebo
treated patients.<br/>Pregnancy: Pregnancy Category C There are no adequate and well controlled studies in
pregnant women. The use of QUESTRAN in pregnancy or lactation or
by women of childbearing age requires that the potential
benefits of drug therapy be weighed against the possible hazards
to the mother and child. QUESTRAN is not absorbed systemically,
however, it is known to interfere with absorption of fat-soluble
vitamins; accordingly, regular prenatal supplementation may not
be adequate (see PRECAUTIONS: Drug
Interactions).<br/>Nursing Mothers: Caution should be exercised when QUESTRAN is administered
to a nursing mother. The possible lack of proper vitamin
absorption described in the���Pregnancy���section may have an effect on nursing
infants.<br/>Pediatric Use: Although an optimal dosage schedule has not been
established, standard texts(6,7) list a usual pediatric dose of 240 mg/kg/day of
anhydrous cholestyramine resin in two to three divided doses,
normally not to exceed 8 gm/day with dose titration based on
response and tolerance. In calculating pediatric dosages, 44.4 mg of anhydrous
cholestyramine resin are contained in 100 mg of QUESTRAN POWDER
and 62.7 mg of anhydrous cholestyramine resin are contained in
100 mg of QUESTRAN LIGHT. The effects of long-term administration, as well as its
effect in maintaining lowered cholesterol levels in pediatric
patients, are unknown.
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Overdosage with QUESTRAN has been reported in a patient taking
150% of the maximum recommended daily dosage for a period of several
weeks. No ill effects were reported. Should an overdosage occur, the
chief potential harm would be obstruction of the gastrointestinal tract.
The location of such potential obstruction, the degree of obstruction,
and the presence or absence of normal gut motility would determine
treatment.
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cholestyramine
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QUESTRAN (Powder, For Suspension)
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The most common adverse reaction is constipation. When used as a
cholesterol-lowering agent predisposing factors for most complaints of
constipation are high dose and increased age (more than 60 years old).
Most instances of constipation are mild, transient, and controlled with
conventional therapy. Some patients require a temporary decrease in
dosage or discontinuation of therapy. Less Frequent Adverse Reactions: Abdominal discomfort and/or
pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, and
steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K
deficiency) as well as Vitamin A (one case of night blindness reported)
and D deficiencies, hyperchloremic acidosis in children, osteoporosis,
rash and irritation of the skin, tongue and perianal area. Rare reports
of intestinal obstruction, including two deaths, have been reported in
pediatric patients. Occasional calcified material has been observed in the biliary
tree, including calcification of the gallbladder, in patients to whom
QUESTRAN has been given. However, this may be a manifestation of the
liver disease and not drug related. One patient experienced biliary colic on each of three occasions
on which he took QUESTRAN. One patient diagnosed as acute abdominal
symptom complex was found to have a���pasty mass���in the transverse colon
on x-ray. Other events (not necessarily drug related) reported in patients
taking QUESTRAN include: Gastrointestinal���GI-rectal bleeding, black stools, hemorrhoidal
bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer
attack, sour taste, pancreatitis, rectal pain, diverticulitis. Laboratory test changes���Liver function abnormalities. Hematologic���Prolonged prothrombin time, ecchymosis, anemia. Hypersensitivity���Urticaria, asthma, wheezing, shortness of breath. Musculoskeletal���Backache, muscle and joint pains, arthritis. Neurologic���Headache, anxiety, vertigo, dizziness, fatigue,
tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia. Eye���Uveitis. Renal���Hematuria, dysuria, burnt odor to urine, diuresis. Miscellaneous���Weight loss, weight gain, increased libido, swollen
glands, edema, dental bleeding, dental caries, erosion of tooth enamel,
tooth discoloration.
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dailymed-instance:indicatio... |
1) QUESTRAN (Cholestyramine for Oral Suspension, USP) 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. QUESTRAN 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 QUESTRAN, 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 QUESTRAN 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 QUESTRAN therapy. The therapy should be
continued to sustain cholesterol reduction. If adequate cholesterol
reduction is not attained, increasing the dosage of QUESTRAN or adding
other lipid-lowering agents in combination with QUESTRAN 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. QUESTRAN monotherapy has been demonstrated to retard the rate of
progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) QUESTRAN is indicated for the relief of pruritus associated
with partial biliary obstruction. QUESTRAN 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 part of
their disease.
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QUESTRAN
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