LACTULOSE liquid

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

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下载 产品特点 (SPC)
13-01-2018

有效成分:

Lactulose (UNII: 9U7D5QH5AE) (Lactulose - UNII:9U7D5QH5AE)

可用日期:

Patrin Pharma

INN(国际名称):

Lactulose

组成:

Lactulose 10 g in 15 mL

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

                                LACTULOSE- LACTULOSE LIQUID
PATRIN PHARMA
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LACTULOSE SOLUTION, USP (10 G/15 ML)
FOR ORAL OR RECTAL ADMINISTRATION
RX ONLY
DESCRIPTION
Lactulose is a synthetic disaccharide in solution form for oral or
rectal administration. Each 15 mL of
lactulose solution contains 10 grams lactulose (and less than 1.6
grams galactose, less than 1.2 grams
lactose, and 0.1 grams or less of fructose).
Lactulose is a colonic acidifier for treatment and prevention of
portal-systemic encephalopathy.
The chemical name for lactulose is
4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following
structural formula:
The molecular weight is 342.30. It is freely soluble in water.
CLINICAL PHARMACOLOGY
Lactulose causes a decrease in blood ammonia concentration and reduces
the degree of portal-systemic
encephalopathy. These actions are considered to be results of the
following:
Bacterial degradation of lactulose in the colon acidifies the colonic
contents.
This acidification of colonic contents results in the retention of
ammonia in the colon as the ammonium
ion. Since the colonic contents are then more acid that the blood,
ammonia can be expected to migrate
from the blood into the colon to from the ammonium ion.
The acid colonic contents converts NH to the ammonium ion (NH )+,
trapping it and preventing its
absorption.
The laxative action of the metabolites of lactulose then expels the
trapped ammonium ion from the
colon.
Experimental data indicate that lactulose is poorly absorbed.
Lactulose given orally to man and
3
4
experimental animals resulted in only small amounts reaching the
blood. Urinary excretion has been
determined to be 3% or less and is essentially complete within 24
hours.
When incubated with extracts of human small intestinal mucosa,
lactulose was not hydrolyzed during a
24-hour period and did not inhibit the activity of these extracts on
lactose. Lactulose reaches the colon
essentially unchanged. There it is metabolized by bacteria with the
formation of low molecular weight
acids that acidify the colon conten
                                
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