Lactulose Information
Lactulose ()
Lactulose () 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 16 g galactose, less than 12 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 CHO. t has the following structural formula:
The molecular weight is 34230. It is freely soluble in water.
Lactulose () 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.
Lactulose () 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.
Lactulose () Contraindications
Since Lactulose () solution contains galactose (less than 16 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Lactulose () Warnings
A theoretical hazard may exist for patients being treated with Lactulose () solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with Lactulose () , patients on Lactulose () therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO as an additional safeguard may be pursued but is considered to be a redundant measure.
Lactulose () Precautions
There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.
There are no known animal data on long-term potential for mutagenicity.
Administration of Lactulose () solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity.
In studies of mice, rats, and rabbits, doses of Lactulose () solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.
Lactulose () Adverse Reactions
Precise frequency data are not available.
Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.
Nausea and vomiting have been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Lactulose () Dosage And Administration
The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of Lactulose () ) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.
Note: Some patients have found that Lactulose () solution may be more acceptable when mixed with fruit juice, water or milk.
Lactulose () How Supplied
Lactulose () Solution USP 10 g/15 mL is available as follows:
8 fl oz (237 mL) bottle
16 fl oz (473 mL) bottle
32 fl oz (946 mL) bottle
15 mL unit dose in trays of 10 cups
30 mL unit dose in trays of 10 cups
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.
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
MG #9201
Rev. 779:04 3/10
Lactulose () Principal Display Panel
UNIT DOSE
Delivers
NDC 50383-779-15
Indications: For the treatment of constipation. See Insert
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Rev. 779:00 2/09
Lactulose () Principal Display Panel
