CHOLESTYRAMINE powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLESTYRAMINE (UNII: 4B33BGI082) (CHOLESTYRAMINE - UNII:4B33BGI082)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1) 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. Cholestyramine 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, 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 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 therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of Cholestyramine or adding other lipid-lowering agents in combination with Cholestyramine should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4 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 ≥190 (≥4.9) <160 (<4.1) NO YES ≥160 (≥4.1) <130 (<3.4) YES YES or NO ≥130 (≥3.4) ≤100 (≤2.6) Cholestyramine monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine for oral suspension 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. Cholestyramine for oral suspension 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.

Product summary:

Cholestyramine for Oral Suspension USP is a yellow colored orange flavored powder available in cans containing 378 grams. Four grams of anhydrous cholestyramine resin are contained in 9 grams of Cholestyramine for Oral Suspension USP. The 378 g can includes a 15 cc scoop. The scoop is not interchangeable with scoops from other products. Made in U.S.A. NDC: 63629-2164-1 Can, 378 g Storage Store between 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Excursions permitted to 15º to 30ºC (59º to 86ºF). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHOLESTYRAMINE- CHOLESTYRAMINE POWDER, FOR SUSPENSION
BRYANT RANCH PREPACK
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CHOLESTYRAMINE FOR ORAL SUSPENSION
DESCRIPTION
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
Cholestyramine is not absorbed from the digestive tract. Four grams of
anhydrous
cholestyramine resin is contained in 9 grams of Cholestyramine for
Oral Suspension
USP. Four grams of anhydrous cholestyramine resin is contained in 5
grams of
Cholestyramine for Oral Suspension USP, Light. It is represented by
the following
structural formula:
Cholestyramine for Oral Suspension USP contains the following inactive
ingredients:
acacia, citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor
(natural and artificial
Orange), polysorbate 80, propylene glycol alginate and sucrose.
Cholestyramine for Oral
Suspension USP, Light contains the following inactive ingredients:
aspartame, citric acid,
colloidal silicon dioxide, D&C Yellow No. 10, FD&C Red No. 40, flavor
(natural and artificial
Orange), maltodextrin, propylene glycol alginate and xanthan gum.
ACTIONS/CLINICAL PHARMACOLOGY
Cholesterol is probably the sole precursor of bile acids. During
normal digestion, bile
acids are secreted into the intestines. A major portion of the bile
acids is absorbed from
the intestinal tract and returned to the liver via the enterohepatic
circulation. Only very
small amounts of bile acids are found in normal serum.
Cholestyramine resin adsorbs and combines with the bile acids in the
intestine to form
an insoluble complex which is excreted in the feces. This results in a
partial removal of
bile acids from the enterohepatic circulation by preventing their
absorption.
The increased fecal loss of bile acids due to Cholestyramine
administration leads to an
increased oxidation of cholesterol to bile acids, a decrease in beta
lipoprotein or low
density lipoprotein