Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CHOLESTYRAMINE (UNII: 4B33BGI082) (CHOLESTYRAMINE - UNII:4B33BGI082)
Par Pharmaceutical, Inc.
CHOLESTYRAMINE
CHOLESTYRAMINE 4 g in 9 g
ORAL
PRESCRIPTION DRUG
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
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).
Abbreviated New Drug Application
QUESTRAN- CHOLESTYRAMINE POWDER, FOR SUSPENSION PAR PHARMACEUTICAL, INC. ---------- 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 Læs hele dokumentet