LACTULOSE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

LACTULOSE

Composition:

LACTULOSE 10 g in 15 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 reduced the blood ammonia levels by 25-50%; this is generally paralleled by an improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of the 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.

Product summary:

Lactulose Solution 10 g/15 mL for Oral or Rectal Administration is available as follows: 16 fl oz (473 mL) bottle 64 fl oz (1893 mL) bottle Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL). Store at controlled room temperature 15° to 30°C (59° to 86°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 30°C (86°F) 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 a 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. Rx Only Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Rev. 795:05 06/22

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LACTULOSE- LACTULOSE SOLUTION
AKORN
----------
LACTULOSE SOLUTION, USP
FOR ORAL OR RECTAL ADMINISTRATION
DESCRIPTION
Lactulose is a synthetic disaccharide in solution form for oral or
rectal administration.
Each 15 mL of lactulose solution contains 10 g lactulose (and less
than 1.6 g galactose,
less than 1.2 g lactose, and 1.2 g or less of other sugars). Also
contains water. The pH
range is 3.0 to 7.0.
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. The
molecular formula is C
H
O
.
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 than
the blood,
12
22
11
ammonia can be expected to migrate from the blood into the colon to
form the
ammonium ion.
The acid colonic contents convert 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 molec