LACTULOSE- lactulose solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LACTULOSE- LACTULOSE SOLUTION
PAR PHARMACEUTICAL
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LACTULOSE SOLUTION, USP
RX ONLY
DESCRIPTION
Lactulose solution, USP 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 FD&C Blue No. 1, FD&C
Yellow No. 6, flavoring and
purified water. A minimal quantity of sodium hydroxide is used to
adjust pH, when necessary. The pH
range is 2.5 to 6.5.
Lactulose solution is a colonic acidifier which promotes laxation.
The chemical name for lactulose is
4-_O-β_-D-galactopyranosyl-D-fructofuranose. It has the following
structural formula:
It has the molecular formula of C
H O and the molecular weight is 342.30. It is freely soluble in
water.
CLINICAL PHARMACOLOGY
Lactulose solution 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 solution reach the colon virtually unchanged. In the colon,
lactulose solution 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 solution 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
12
22
11
For the treatment of constipation. In patients with a history of
chronic constipation, lactulose solution
therapy increases the number of bowel movements per day a