LACTULOSE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PAI Holdings, 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 0121-0577-08:    8 fl oz (237 mL) bottles NDC 0121-0577-16:    16 fl oz (473 mL) bottles NDC 0121-0577-32:    32 fl oz (946 mL) bottle NDC 0121-4577-15:    15 mL unit dose cup NDC 0121-4577-40:    Case contains 40 unit dose cups of 15 mL (0121-4577-15) packaged in 4 trays of 10 unit dose cups each. NDC 0121-4577-06:    Case contains 96 unit dose cups of 15 mL (0121-4577-15) packaged in 6 cartons of 16 unit dose cups each. NDC 0121-1154-30:    30 mL unit dose cup NDC 0121-1154-40:    Case contains 40 unit dose cups of 30 mL (0121-1154-30) packaged in 4 trays of 10 unit dose cups each. NDC 0121-1154-00:    Case contains 100 unit dose cups of 30 mL (0121-1154-30) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1154-06:    Case contains 96 unit dose cups of 30 mL (0121-1154-30) packaged in 6 cartons of 16 unit dose cups each. Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL). Store at controlled room temperature, 20°-25°C (68°-77°F). [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 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. Keep tightly closed. Dispense in original container or tight, light-resistant container 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
PAI HOLDINGS, LLC
----------
LACTULOSE SOLUTION USP 10 G/15 ML
I05770920
R09/20
RX ONLY
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
4-0-ß-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 th