PHL-CHOLESTYRAMINE POWDER FOR SUSPENSION 400GM/CAN

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CHOLESTYRAMINE RESIN

Dostopno od:

PHARMEL INC

Koda artikla:

C10AC01

INN (mednarodno ime):

COLESTYRAMINE

Odmerek:

400G

Farmacevtska oblika:

POWDER FOR SUSPENSION

Sestava:

CHOLESTYRAMINE RESIN 400G

Pot uporabe:

ORAL

Enote v paketu:

400G

Tip zastaranja:

Prescription

Terapevtsko območje:

BILE ACID SEQUESTRANTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0101047004; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2010-10-06

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
PHL-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
PHARMEL INC.
DATE OF PREPARATION:
8699 8th Avenue
October 26, 2004
Montréal, Quebec
H1Z 2X4
CONTROL # :
094312
-2- PRODUCT MONOGRAPH
PR
PHL
-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
phl-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.
phl-
CHOLESTYRAMINE may be useful in lowering elevated cho