LACTULOSE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

LACTULOSE

Composition:

LACTULOSE 10 g in 15 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur. 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 available as follows: 32 fl oz (946 mL) bottle Lactulose Solution contains lactulose 667 mg/mL (10 g/15 mL). Store at controlled room temperature 15°-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 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 original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Rx only Distributed by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 MG #9201 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Rev. 779:04 3/10

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LACTULOSE- LACTULOSE SOLUTION
AIDAREX PHARMACEUTICALS LLC
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LACTULOSE SOLUTION, USP
FOR ORAL ADMINISTRATION
DESCRIPTION
Lactulose is a synthetic disaccharide in solution form for oral
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 4.8 to 6.0.
Lactulose is a colonic acidifier which promotes laxation.
The chemical name for lactulose is
4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular
formula is C
H O . t has the following structural formula:
The molecular weight is 342.30. It is freely soluble in water.
CLINICAL PHARMACOLOGY
Lactulose is poorly absorbed from the gastrointestinal tract and no
enzyme capable of hydrolysis of this
disaccharide is present in human gastrointestinal tissue. As a result,
oral doses of lactulose reach the
colon virtually unchanged. In the colon, lactulose is broken down
primarily to lactic acid, and also to
small amounts of formic and acetic acids, by the action of colonic
bacteria, which results in an increase
in osmotic pressure and slight acidification of the colonic contents.
This in turn causes an increase in
stool water content and softens the stool.
Since lactulose does not exert its effect until it reaches the colon,
and since transit time through the
colon may be slow, 24 to 48 hours may be required to produce the
desired bowel movement.
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.
INDICATIONS AND USAGE
For the treatment of constipation. In patients with a history of
chronic constipation, lactulose solution
12
22
11
therapy increases the number of bowel movements per day and the number
of days on which bowel
movements occur.
CONTRAINDICATIONS
Since lactulose solution contains galactose (less than 1.6 g/15 mL),
it is contraindicated in patients who
req