LACTULOSE SOLUTION- lactulose solution usp, 10 g/15 ml solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

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 reduces the blood ammonia level by 25 to 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 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 solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution 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, USP, 10 g/15 mL is a clear, yellow to golden-yellow solution supplied in 4-ounce (118 mL) amber plastic bottle, 8-ounce (236 mL) white plastic bottle, 1-pint (473 mL) amber plastic bottle, 32-ounce (946 mL) white plastic bottle. Lactulose solution contains: 667 mg lactulose/mL (10 g/15 mL). Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Do not freeze. Keep tightly closed. 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 semisolid, 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: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 Issued: 04/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LACTULOSE SOLUTION- LACTULOSE SOLUTION USP, 10 G/15 ML SOLUTION
RISING PHARMACEUTICALS, INC.
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LACTULOSE SOLUTION USP, 10 G/15 ML
RISING PHARMACEUTICALS, INC.
DESCRIPTION
Lactulose is a synthetic disaccharide in solution form for oral or
rectal administration.
Each 15 mL of Lactulose Solution USP contains 10 g lactulose (and less
than 1.6 g
galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). It
also contains D&C
Yellow No. 10, FD & C Yellow No. 6 and Purified Water.
Lactulose is a colonic acidifier for treatment and prevention of
portal-systemic
encephalopathy.
The chemical name for lactulose is
4-0-ß-D-galactopyranos-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
than the blood,
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
3
4
+
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 met