PREVALITE- cholestyramine powder, for suspension

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

cholestyramine (UNII: 4B33BGI082) (cholestyramine - UNII:4B33BGI082)

Sẵn có từ:

Upsher-Smith Laboratories, LLC

INN (Tên quốc tế):

cholestyramine

Thành phần:

cholestyramine 4 g in 5.5 g

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

1) Prevalite® (cholestyramine for oral suspension, USP) 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. Prevalite® (cholestyramine for oral suspension, USP) 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

Tóm tắt sản phẩm:

Prevalite® (cholestyramine for oral suspension, USP) powder is available in cartons of forty-two and sixty single-dose packets and in cans containing 231 grams. 5.5 grams of Prevalite® (cholestyramine for oral suspension, USP) powder contain 4 grams of anhydrous cholestyramine resin. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PREVALITE- CHOLESTYRAMINE POWDER, FOR SUSPENSION
UPSHER-SMITH LABORATORIES, LLC
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PREVALITE
(CHOLESTYRAMINE FOR ORAL SUSPENSION, USP)
RX ONLY
DESCRIPTION
Prevalite
(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. The cholestyramine resin
in Prevalite
(cholestyramine for
oral suspension, USP) is not absorbed from the digestive tract. 5.5
grams of Prevalite
(cholestyramine
for oral suspension, USP) contain 4 grams of anhydrous cholestyramine
resin. It is represented by the
following structural formula:
Prevalite
(cholestyramine for oral suspension, USP) powder contains the
following inactive
ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80,
propylene glycol alginate, and
orange flavor.
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 deposited in