LACTULOSE SOLUTION, USP | Lactulose

23:09 EDT 31st October 2014 | BioPortfolio
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FOR ORAL ADMINISTRATION

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 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 342.30. It is freely soluble in water.

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.

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.

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.

Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics.

In the event that an unusual diarrheal condition occurs, contact your physician.

Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.

Results of preliminary studies in humans and rats suggest that non-absorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.

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.

Pregnancy category B. Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.

Safety and effectiveness in pediatric patients have not been established.

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.

There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.

Oral LD : The acute oral LD of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.

Dialysis: Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.

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 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.

Rx only

Distributed by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

MG #9201

Rev. 779:04 3/10

UNIT DOSE

Delivers 15 mL

NDC 50383-779-15

Lactulose Solution USP 10 g/15 mL

Indications: For the treatment of constipation. See Insert

Rx ONLY

 

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 779:00 2/09

NDC 50383-779-16

LACTULOSE SOLUTION, USP

10 g/15 mL

 

INDICATIONS: For the treatment of constipation. See attached insert labeling for full information.

 

Rx only

 

16 fl oz (473 mL)

IMAGE 965dd69b-0d4d-42d1-aded-e9860fa25e36-03.jpg

Manufacturer

Hi-Tech Pharmacal Co., Inc.

Active Ingredients

Source

Clinical Trials [22 Associated Clinical Trials listed on BioPortfolio]

Is Continuous Lactulose Therapy Necessary for Patients With Hepatic Encephalopathy? A Study of Controlled Lactulose Withdrawal

After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is routinely continued indefinitely as maintenance therapy. Although widely used for this indication, la...

A Preference Study Comparing Kristalose® and Liquid Lactulose

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Efficacy of Combined Oral L-Ornithine-L-Aspartate and Lactulose in Patients With Hepatic Encephalopathy

Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, do...

Lactulose for the Prevention of Nosocomial Infections in Children

The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to prevent hospital acquired infection in children

Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women

This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulo...

PubMed Articles [26 Associated PubMed Articles listed on BioPortfolio]

Continuous synthesis of lactulose in an enzymatic membrane reactor reduces lactulose secondary hydrolysis.

Newly developed parallel small-scale enzymatic membrane reactors (EMRs) were used to enhance the synthesis of lactulose using β-galactosidase. Under batch operation, the productivity of lactulose dec...

In Vitro Fermentation of Lactulose by Human Gut Bacteria.

Lactulose has been known as a prebiotic that can selectively stimulate the growth of beneficial bifidobacteria and lactobacilli. Recent studies have indicated that Streptococcus mutans, Clostridium pe...

Intestinal permeability in patients with metastatic colon cancer treated with patupilone.

Abstract Background: Only a limited number of cytotoxic drugs have shown activity in metastatic colorectal carcinoma. Patupilone is a novel agent with promising activity in this common cancer. Diarrhe...

Standardising the Lactulose Mannitol Test of Gut Permeability to Minimise Error and Promote Comparability.

Lactulose mannitol ratio tests are clinically useful for assessing disorders characterised by changes in gut permeability and for assessing mixing in the intestinal lumen. Variations between currently...

Lactulose and Lactobacillus plantarum: a potential complementary synbiotic to control post-weaning colibacillosis in piglets.

The potential of a prebiotic oligosaccharide lactulose, a probiotic strain of Lactobacillus plantarum, or their synbiotic combination to control post-weaning colibacillosis in pigs were evaluated usin...

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