QUESTRAN- cholestyramine powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

CHOLESTYRAMINE

Composition:

CHOLESTYRAMINE 4 g in 9 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1) QUESTRAN (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. QUESTRAN 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 QUEST

Product summary:

QUESTRAN ® Powder (Cholestyramine for Oral Suspension USP) is available in cans containing 378 grams and in cartons of sixty 9 gram packets. Four grams of anhydrous cholestyramine resin are contained in 9 grams of QUESTRAN Powder. The 378 g can includes a 15 cc scoop. The scoop is not interchangeable with scoops from other products. NDC 49884-936-66 Can, 378 g NDC 49884-936-65 Carton of 60, 9 g packets QUESTRAN ® LIGHT (Cholestyramine for Oral Suspension USP), Light is available in cans containing 210 grams and in cartons of sixty 5 gram packets. Four grams of anhydrous cholestyramine resin are contained in 5 grams of QUESTRAN LIGHT. The 210 g can includes a 9 cc scoop. The scoop is not interchangeable with scoops from other products. NDC 49884-937-67 Can, 210 g NDC 49884-937-65 Carton of 60, 5 g packets Store between 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature]. Excursions permitted to 15º-30ºC (59º-86ºF).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUESTRAN- CHOLESTYRAMINE POWDER, FOR SUSPENSION
PAR PHARMACEUTICAL, INC.
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QUESTRAN POWDER FOR ORAL SUSPENSION
DESCRIPTION
QUESTRAN
(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
QUESTRAN is not absorbed from the
digestive tract. Four grams of anhydrous cholestyramine resin is
contained in 9 grams of QUESTRAN
powder. Four grams of anhydrous cholestyramine resin is contained in 5
grams of QUESTRAN
LIGHT. It is represented by the following structural formula:
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.
QUESTRAN 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 QUESTRAN 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,
QUESTRAN 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 QUESTRAN
reduces excess bile acids deposited in the dermal tissue with
resultant decrease in pruritus.
QUESTRAN (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 an