Data from FDA - Curated by EPG Health - Last updated 22 December 2016
This will usually respond
Reduction of serum or red cell folate has been reported over long term administration of cholestyramine resin.
Supplementation with folic acid should be considered in these cases.
There is a possibility that
This would especially be
Cholestyramine resin may produce or
In patients with preexisting constipation, the starting dose should be 1 pouch or 1 scoop once daily for 5 to 7 days,
Particular effort should be made to
Information for Patients
Inform your physician if you are pregnant or plan to become pregnant or are breast-feeding.
Sipping or holding the resin suspension in the mouth for
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
The LRC-CPPT showed a dose-related
Based on the
Interference with the absorption of oral phosphate supplements has been observed with another positively-charged bile acid sequestrant.
Cholestyramine resin may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation.
The discontinuance of cholestyramine resin could pose a
Because cholestyramine binds bile acids, cholestyramine resin 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 cholestyramine resin is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of
SINCE CHOLESTYRAMINE RESIN MAY BIND OTHER DRUGS GIVEN CONCURRENTLY,
The relevance of this laboratory observation from studies in
In the LRC-CPPT study referred to above,
When the many different categories of tumors are examined, various alimentary system
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
Pregnancy Pregnancy Category C There are
The use of cholestyramine in pregnancy or lactation or by
Cholestyramine is not absorbed systemically, however, it is known to interfere with absorption of fat-soluble vitamins; accordingly, regular prenatal supplementation may not be
Pediatric Use Although an
In calculating pediatric dosages, 70.2 mg of anhydrous cholestyramine resin are contained in 100 mg of Cholestyramine for Oral Suspension USP Light.
The effects of
When used as a cholesterol-lowering agent predisposing factors for
Occasional calcified material has been observed in the biliary tree, including calcification of the gallbladder, in patients to whom cholestyramine resin 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 a cholestyramine for oral suspension product.
One patient diagnosed as
Other events (not necessarily drug related) reported in patients taking cholestyramine resin include: Gastrointestinal: GI-rectal
Laboratory Test Changes: Liver function
Hematologic: Prolonged prothrombin time, ecchymosis, anemia.
Hypersensitivity: Urticaria, asthma, wheezing,
Renal: Hematuria, dysuria,
DOSAGE AND ADMINISTRATION The
The suggested time of administration is at mealtime but may be
Cholestyramine for Oral Suspension USP Light 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
Additive effects on LDL-cholesterol are also seen with combined nicotinic acid/cholestyramine therapy.
See the PRECAUTIONS, Drug Interactions for
Preparation The color of Cholestyramine for
Place the contents of one single-dose pouch or one level scoopful of
Cholestyramine for Oral
Suspension USP Light powder in a glass or cup.
Add at least 2 to 3 ounces of water or the beverage of your choice.
Stir to a uniform consistency.
Cholestyramine for Oral Suspension USP Light powder may also be mixed with highly
|Agency product number||4B33BGI082|
|Date Last Revised||28-03-2016|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].|
|Marketing authorisation holder||Eon Labs, Inc.|