考来烯胺(消胆安)说明书-施贵宝.docxVIP

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考来烯胺(消胆安)说明书-施贵宝考来烯胺(消胆安)说明书-施贵宝

QUESTRAN LITE PowderSCHEDULING STATUSS2PROPRIETARY NAME(and dosage form):QUESTRAN LITE PowderCOMPOSITION?Each sachet of QUESTRAN LITE powder contains 4?g or 8?g of anhydrous?cholestyramine, the active ingredient. Each 4?g sachet contains 16,8?mg phenylalanine and each 8?g sachet contains 33,6?mg phenylalanine, from aspartame, as sweetener.PHARMACOLOGICAL CLASSIFICATIONA7.5 - Serum-cholesterol reducers.PHARMACOLOGICAL ACTION?QUESTRAN LITE is the chloride salt of a basic anion-exchange resin, cholestyramine. Cholestyramine is very hydrophilic, but it is not soluble in water, nor is it hydrolysed by digestive enzymes. Thus, QUESTRAN LITE is not absorbed from the intestinal tract.Cholestyramine resin adsorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the faeces. The increased faecal loss of bile acids leads to an increased oxidation of cholesterol to bile acids and a decrease in serum cholesterol levels and low density lipoprotein cholesterol serum levels.When administered properly, QUESTRAN LITE usually leads to a significant reduction (15% or more) in serum cholesterol levels.In patients with pruritis associated with partial biliary obstruction the reduction of serum bile acid levels by QUESTRAN LITE is thought to reduce excess bile acids deposited in the dermal tissues and promote their excretion with the faeces. The relief from itching afforded to most of these patients by QUESTRAN LITE is attributed to this mobilisation. It is postulated that in bile-salt diarrhoea, QUESTRAN LITE binds conjugated dihydroxy bile salts which are known to have a cathartic effect.INDICATIONSFor reduction of serum cholesterol and low density cholesterol, lipoprotein levels in primary hypercholesterolaemia in conjunction with an appropriate diet. QUESTRAN LITE is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolaemia (elevated low density lipoproteins)

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