CHOLESTYRAMINE powder, for suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Cholestyramine (UNII: 4B33BGI082) (Cholestyramine - UNII:4B33BGI082)

Dostępny od:

TAGI Pharma, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 for Oral Suspension, USP 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 initiatin

Podsumowanie produktu:

Cholestyramine for Oral Suspension, USP orange flavor is available in cartons of sixty 8.3 gram pouches and in a can containing 348.6 grams. 8.3 grams of Cholestyramine for Oral Suspension, USP contain 4 grams of anhydrous cholestyramine resin. NDC 51224-011-20 Carton of 60 single-dose pouches NDC 51224-011-10 Can, 348.6 g (containing a scoop that is not interchangeable with scoops from other products) Store at 20°C 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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CHOLESTYRAMINE- CHOLESTYRAMINE POWDER, FOR SUSPENSION
TAGI PHARMA, INC.
----------
CHOLESTYRAMINE FOR ORAL SUSPENSION, USP
RX ONLY
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. Cholestyramine
resin is not absorbed
from the digestive tract. 8.3 grams of Cholestyramine for Oral
Suspension, USP contain
4 grams of cholestyramine resin. It is represented by the following
structural formula:
REPRESENTATION OF STRUCTURE OF MAIN POLYMERIC GROUPS
INACTIVE INGREDIENTS: sucrose (429.5 mg/g), propylene glycol alginate,
natural orange
flavor, anhydrous citric acid, 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 levels by
cholestyramine resin reduces excess bile acids deposited in the dermal
tissue with
resultant decrease in pruritus.
CLINICAL STUDIES
In a large, plac