LACTULOSE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Care Products, 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:

NDC 49999-0800-32 Bottles of 32 fl oz (946 mL) Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL ) Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP] 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 30ºC (86ºF) 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. Keep tightly closed. Dispense in original container or tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LACTULOSE- LACTULOSE SOLUTION
QUALITY CARE PRODUCTS, LLC
----------
LACTULOSE 10G/15ML
32 FL OZ (946 ML) SOLUTION
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 FD&C Yellow No. 6, purified water, and
flavoring. Sodium hydroxide
used to adjust pH . The pH range is 2.5 to 6.5.
Lactulose 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:
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 solution
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 solution 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 which bowel
movements occur.
CONTRAINDICATIONS
Since lactulose solution contains galactose (less than