PMS-LACTULOSE SYR 667MG/ML SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

LACTULOSE

Beschikbaar vanaf:

PHARMASCIENCE INC

ATC-code:

A06AD11

INN (Algemene Internationale Benaming):

LACTULOSE

Dosering:

667MG

farmaceutische vorm:

SOLUTION

Samenstelling:

LACTULOSE 667MG

Toedieningsweg:

ORAL

Eenheden in pakket:

1 L/15ML/30ML/250ML/500ML

Prescription-type:

OTC

Therapeutisch gebied:

AMMONIA DETOXICANTS

Product samenvatting:

Active ingredient group (AIG) number: 0113020001; AHFS:

Autorisatie-status:

MARKETED

Autorisatie datum:

1996-10-16

Productkenmerken

PRESCRIBING INFORMATION
PMS-LACTULOSE
LACTULOSE SOLUTION, USP
667 MG/ML
COLONIC CONTENT ACIDIFIER - LAXATIVE
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision:
January 21, 2015
Submission Control No: 180273
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_pms-LACTULOSE Prescribing Information _
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PRESCRIBING INFORMATION
PMS-LACTULOSE
LACTULOSE SOLUTION, USP
667 MG/ML
THERAPEUTIC CLASSIFICATION
Colonic Content Acidifier - Laxative
ACTION AND CLINICAL PHARMACOLOGY
pms-LACTULOSE (lactulose solution), a disaccharide sugar containing
one molecule of
galactose and one molecule of fructose, is a synthetic derivative of
lactose. pms-LACTULOSE is
a solution in water prepared from Lactulose concentrate. It contains
lactulose, galactose, lactose,
fructose and epilactose.
In patients with portal-systemic encephalopathy (PSE), lactulose
solution causes a decrease in
blood ammonia concentration and reduces the degree of PSE. Although
the mechanism of action
of lactulose solution has not been clearly defined, it appears to be
associated primarily with the
metabolism of the sugar in the lower intestinal tract. The breakdown
of lactulose solution to
organic acids (i.e., lactic acid and small amounts of formic and
acetic acids) by the saccharolytic
bacteria in the colon acidifies the contents of the colon. In patients
with PSE who respond to
lactulose solution, a decrease in fecal pH occurs. Acidification of
colon contents inhibits the
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_pms-LACTULOSE Prescribing Information _
_Page 3 of 14_
nonionic diffusion of ammonia from the colon into the blood. In
addition, since the contents of
the colon are more acidic than is blood, ammonia (NH
3
) can diffuse from the blood into the
colon. In the acidic colon, ammonia is converted to ammonium ions (NH4
+
) thereby preventing
its absorption. In a similar manner, the absorption of amines (which
may also contribute to the
development of PSE) may also be reduced.
Finally the cathartic action of lactulose solution (which is probably
caused by the osmotic