CHOLESTYRAMINE powder, for suspension

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Upsher-Smith Laboratories, Inc.

ИНН (Международная Имя):

CHOLESTYRAMINE

состав:

CHOLESTYRAMINE 4 g in 9 g

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

1) Cholestyramine for Oral Suspension 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 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 overweight. Prior to initi

Обзор продуктов:

Cholestyramine for Oral Suspension, USP powder orange flavor is available in cartons of sixty 9 gram pouches and in cans containing 378 grams. Nine grams of Cholestyramine for Oral Suspension, USP powder contain 4 grams of anhydrous cholestyramine resin. 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.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CHOLESTYRAMINE- CHOLESTYRAMINE POWDER, FOR SUSPENSION
UPSHER-SMITH LABORATORIES, INC.
----------
CHOLESTYRAMINE FOR ORAL SUSPENSION, USP
RX ONLY
DESCRIPTION
Cholestyramine for Oral Suspension, USP 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. Nine
grams of Cholestyramine for Oral Suspension, USP powder contain 4
grams of cholestyramine resin. It
is represented by the following structural formula:
REPRESENTATION OF STRUCTURE OF MAIN POLYMERIC GROUPS
INACTIVE INGREDIENTS: citric acid anhydrous, fructose, mono ammonium
glycyrrhizinate, pectin,
propylene glycol alginate, sorbitol, sucrose, xanthan gum, natural and
artificial orange flavor, D&C
yellow No. 10 aluminum lake, 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 levels by cholestyramine
resin reduces excess bile acids d