CHOLESTYRAMINE powder, for suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Bryant Ranch Prepack

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 Cholestyram

Povzetek izdelek:

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. NDC: 72162-1504-02: 378 g in a CAN. Storage Store between 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Excursions permitted to 15º to 30ºC (59º to 86ºF).

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

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