CHOLESTYRAMINE POWDER FOR SUSPENSION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CHOLESTYRAMINE RESIN

متاح من:

SORRES PHARMA INC

ATC رمز:

C10AC01

INN (الاسم الدولي):

COLESTYRAMINE

جرعة:

4G

الشكل الصيدلاني:

POWDER FOR SUSPENSION

تركيب:

CHOLESTYRAMINE RESIN 4G

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30X5G POUCHES

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

BILE ACID SEQUESTRANTS

ملخص المنتج:

Active ingredient group (AIG) number: 0101047003; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2010-10-19

خصائص المنتج

PRODUCT MONOGRAPH
PR
CHOLESTYRAMINE
LIGHT POWDER
(Cholestyramine Resin for Oral Suspension, USP)
4g / 5g Dose
REGULAR POWDER
(Cholestyramine Resin for Oral Suspension, USP)
4g / 9g Dose
ANTIHYPERCHOLESTEROLEMIC AND ANTIDIARRHEAL
SORRES PHARMA INC.
DATE OF PREPARATION:
6111 Royalmount Avenue, suite#100
April 15, 2010
Montréal, CANADA
H4P 2T4
CONTROL # :
137563
-2- PRODUCT MONOGRAPH
PR
CHOLESTYRAMINE
(Cholestyramine Resin for Oral Suspension, USP)
Light Powder: 4g / 5g Dose
Regular Powder: 4g / 9g Dose
THERAPEUTIC CLASSIFICATION
Antihypercholesterolemic and Antidiarrheal
ACTION AND CLINICAL PHARMACOLOGY
Cholestyramine resin is a bile-acid sequestrant and cholesterol
lowering agent. Following oral
administration, cholestyramine resin releases chloride ions and
absorbs bile acid in the intestine,
forming a non-absorbable complex which is excreted along with
unchanged resin in the feces. This
results in partial removal of bile acid from the enterohepatic
circulation. The increased fecal loss
of bile acids following 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 cholestyramine resin produces an increase
in hepatic synthesis of
cholesterol, plasma cholesterol levels fall.
-3-
INDICATIONS AND CLINICAL USE
CHOLESTYRAMINE (cholestyramine resin) is indicated as adjunctive
therapy to diet and exercise
for the reduction of elevated serum cholesterol in patients with
primary hypercholesterolemia
(elevated low density lipoproteins). Such reduction of serum
cholesterol may reduce the risks of
atherosclerotic coronary artery disease and myocardial infarction.
Patients should be placed on a
standard cholesterol-lowering diet at least equivalent to the American
Heart Association (AHA) Step
1 Diet, which should be continued during treatment. If appropriate, a
programme of weight control
and physical exercise should be implemented. CHOLESTYRAMINE may be
useful in lowering
elevated