LACTULOSE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Xttrium Laboratories, Inc.

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 a colorless to yellow, unflavored solution available in the following container sizes: 15 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-15) 30 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-30) 8 fl. oz. (237 mL) white bottles (NDC 0116-4005-08) 16 fl. oz. (473 mL) white bottles (NDC 0116-4005-16) 32 fl. oz. (946 mL) white bottles (NDC 0116-4005-32) Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL). Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. 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 change to a semisolid, 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. To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LACTULOSE- LACTULOSE SOLUTION
XTTRIUM LABORATORIES, INC.
----------
LACTULOSE SOLUTION, USP
LACTULOSE SOLUTION, USP
10G/15ML
FOR ORAL ADMINISTRATION
RX ONLY
DESCRIPTION
​Lactulose solution is a synthetic disaccharide in solution form for
oral administration.
Each 15 mL of lactulose 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, D&C Yellow
No. 10, and FD&C Yellow No. 6. 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-ß-D-galactopyranosyl-D-fructofuranose. It has
the following structural formula:
C
H
0
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
12
22
11
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 therapy increases the number of bowel movements per
day and the
number of days on whic