Lactulose

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# Overview
Lactulose is a gastrointestinal, laxative and hyperosmotic agent that is FDA approved for the treatment of constipation.   Common adverse reactions include bloating symptom, diarrhea, epigastric pain, flatulence, nausea, vomiting, muscular cramps, intestinal cramps..

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- 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.
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lactulose in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Lactulose in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Lactulose in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lactulose in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Lactulose in pediatric patients.

# Contraindications
- Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.

# 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 H2 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 CO2 as an additional safeguard may be pursued but is considered to be a redundant measure.

# Adverse Reactions

## Clinical Trials Experience
- 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.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Lactulose in the drug label.

# Drug Interactions
- 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.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 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.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lactulose in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Lactulose during labor and delivery.

### Nursing Mothers
- 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.

### Pediatric Use
There is no FDA guidance on the use of Lactulose with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Lactulose with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Lactulose with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Lactulose with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Lactulose in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Lactulose in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lactulose in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Lactulose in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Lactulose in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Lactulose in the drug label.

# Overdosage
- 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 LD50: The acute oral LD50 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.

# Pharmacology

## Mechanism of Action
- 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.

## Structure
- 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 0.1 g or less of fructose).
- Lactulose is a colonic acidifier which promotes laxation.
- The chemical name for lactulose is 4-O--D-galactopyranosyl-D-fructofuranose. It has the following structural formula:

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Lactulose in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Lactulose in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Lactulose in the drug label.

# Clinical Studies

### Carcinogenesis, Mutagenesis, Impairment of Fertility=
- 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.

# How Supplied
- Lactulose Solution is a natural colored and an unflavored solution available in 8 fl oz (237 mL) and 1 quart (946 mL) bottles.
- Lactulose Solution contains lactulose 670 mg/mL (10 g/15 mL).
- 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 86F (30C) 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 a tight, light-resistant container as defined in the USP, with a child-resistant closure.
- Manufactured and packaged by:
- Fresenius Kabi Austria GmbH
- Estermannstrae 17
- 4020 Linz Austria
- Distributed by:
- Actavis Inc.
- 60 Columbia Rd., Bldg. B
- Morristown, NJ 07960 USA
- FORM NO. 1358
- Rev. January 2011

## Storage
- Store between 36-86F (2-30C). Do not freeze.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- In the event that an unusual diarrheal condition occurs, contact your physician.

# Precautions with Alcohol
- Alcohol-Lactulose interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Kristalose
- Cholac
- Constilac
- Constulose
- Generlac
- Enulose

# Look-Alike Drug Names
There is limited information regarding Lactulose Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price