LACTULOSE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE)

Tillgänglig från:

Torrent Pharmaceuticals Limited

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 years in controlled studies. Since lactulose solution contains galactose (less than 1.6 g/15 mL) it is contraindicated in patients who require a low galactose diet.

Produktsammanfattning:

Lactulose Solution, USP, 10 g/15 mL is a clear, colorless to pale brownish-yellow viscous, unflavored solution supplied in 8 fl oz (237 mL) NDC # 13668-574-08, 16 fl oz (473 mL) NDC # 13668-574-10 and 32 fl oz (946 mL) NDC # 13668-574-12 bottles. Lactulose Solution contains: 667 mg lactulose / mL (10 g/15 mL). Store between 15 o  to 30 o C (59 o  to 86 o F). Do not freeze. Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use. Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Distributed by: ​TORRENT PHARMA INC. Basking Ridge, NJ 07920 Rev10/2020

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LACTULOSE- LACTULOSE SOLUTION
TORRENT PHARMACEUTICALS LIMITED
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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 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