CHOLESTYRAMINE LIGHT powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EPIC PHARMA, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1) Cholestyramine for Oral Suspension, USP Light 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 Light 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 over

Product summary:

Cholestyramine for Oral Suspension, USP Light powder orange flavor is available in cartons of sixty 5.7 gram pouches and in cans containing 239.4 grams. Each 5.7 gram dose of Cholestyramine for Oral Suspension, USP Light powder contains 4 grams of anhydrous cholestyramine resin. NDC # 42806-270-95 Carton of 60 pouches NDC # 42806-271-97 Can, 239.4 g (containing a scoop that is not interchangeable with scoops from other products) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Always replace plastic lid after using. KEEP OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHOLESTYRAMINE LIGHT- CHOLESTYRAMINE LIGHT POWDER, FOR SUSPENSION
EPIC PHARMA, LLC
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CHOLESTYRAMINE FOR ORAL SUSPENSION, USP LIGHT
DESCRIPTION
Cholestyramine for Oral Suspension, USP Light powder, 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.
Cholestyramine resin is
not absorbed from the digestive tract. Each 5.7 grams of
Cholestyramine for Oral
Suspension, USP Light powder contain 4 grams of cholestyramine resin.
It is
represented by the following structural formula:
REPRESENTATION OF STRUCTURE OF MAIN POLYMERIC GROUPS
INACTIVE INGREDIENTS: aspartame, citric acid anhydrous, colloidal
silicon dioxide,
fructose, mannitol, mono ammonium glycyrrhizinate, pectin, propylene
glycol alginate,
sorbitol, xanthan gum, natural and artificial orange flavor, D&C
yellow No. 10 aluminum
lake and FD&C yellow No. 6 aluminum lake.
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 resin
administration leads to
an increased oxidation of cholesterol to bile acids, a decrease in
beta lipoprotein or low
density lipoprotein plasma levels and a decrease in serum cholesterol
levels. Although in
man, cholestyramine resin produces an increase in hepatic synthesis of
cholesterol,
plasma cholesterol levels fall.
In patients with partial biliary obstruction, the reduction of serum
bile acid level