Lactulose: Package Insert / Prescribing Info

Lactulose Description

LACTULOSE For Oral Solution is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0.

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 formula is C 12H 22O 11. The molecular weight is 342.30.
It is freely soluble in water.

Lactulose - Clinical Pharmacology

LACTULOSE is poorly absorbed from the gastro-intestinal 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 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.

Indications and Usage for Lactulose

LACTULOSE For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Contraindications

Since LACTULOSE For Oral Solution contains galactose (less than 0.3 g/10 g as a total sum with lactose), it is contraindicated in patients who require a low galactose diet.

Warnings

A theoretical hazard may exist for patients being treated with lactulose who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H 2gas 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 2as an additional safeguard may be pursued but is considered to be a redundant measure.

Precautions

Adverse Reactions/Side Effects

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.

Overdosage

Lactulose Dosage and Administration

The usual adult dosage is 10 g to 20 g of lactulose daily. The dose may be increased to 40 g daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.

How is Lactulose supplied

LACTULOSE For Oral Solution is available in single dose packets of 10 g (NDC 69067-010-15) andd single dose packets of 20 g (NDC 69067020-15). The packets are supplied as follows:

NDC 69067-010-15 (Carton of fifteen 10 g packets)

NDC 69067-020-14 (carton of fifteen 20g paclets)

To report SUSPECTED ADVERSE REACTIONS, contact Foxland Pharmaceuticals Inc. at 1-844-700-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Distributed by:
FOXLAND PHARMACEUTICALS, INC.
Hazlet, NJ 07730

Issued: October 2024

PRINCIPAL DISPLAY PANEL - 10 Gram Packet Carton

NDC 69067-010-15

Rx Only

Lactulose 10 g packets

For Oral Solution

Fifteen Single Dose Packets

Foxland Pharmaceuticals, Inc

NDC 69067-020-15

Rx Only

Lactulose, 20 g Packets

Fifteen single dose packets

Foxland, Pharmaceuticals, Inc.