Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15mL contains: Lactulose 10g (less than 1.6g galactose, less than 1.2g lactose, and 0.1g or less of fructose). It also contains D&C Yellow No. 10, FD & C Yellow No. 6 and Purified Water.
Lactulose is a colonic acidifier which promotes laxation.
The chemical name for lactulose is 4-0-ß-D-galactopyranos-D-fructofuranose. It 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 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.

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 2 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 2 as an additional safeguard may be pursued but is considered to be a redundant measure.

General
Since lactulose solution contains galactose (less than1.6 g/15 mL) and lactose (less than 1.2 g/15 mL), it should be used with caution in diabetics. Infants receiving lactulose may develop hyponatremia and dehydration.

Precise frequency data are not available. Lactulose may produce gaseous distention with flatulence or belching and abdominal discomfort such as cramping in about 20% of patients. 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 Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Signs and Symptoms

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 50

The acute oral LD 50 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.

Adult
The usual adult oral dosage is 2 to 3 tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily.

Pediatric

Very little information on the use of lactulose in young children and adolescents has been recorded. As with adults, the subjective goal in proper treatment is to produce 2 to 3 soft stools daily. On the basis of information available, the recommended initial daily oral dose in infants is 2.5 to 10 mL in divided doses. For older children and adolescents, the total daily dose is 40 to 90 mL. If the initial dose causes diarrhea, the dose should be reduced immediately. If diarrhea persists, lactulose should be discontinued.
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 a clear, yellow to golden-yellow solution supplied as follows:
NDC: 81033-241-15 - 15 mL Unit Dose Cup
NDC: 81033-241-50 - Case containing 100 (15mL unit dose cups)
NDC: 81033-241-30 - 30 mL Unit Dose Cup
NDC: 81033-241-51 - Case containing 100 (30mL unit dose cups)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Keep tightly closed.
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 semisolid, 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.

Packaged by:
Kesin Pharma
Oldsmar FL, 34677
PI Rev. 10/2024

Delivers 15ml

NDC 81033-241-15

LACTULOSE SOLUTION, USP 10 g/15 mL

FOR ORAL OR RECTAL ADMINISTRATION

Store at 20-25°C (68-77°F)

PKG By Kesin Pharma

Oldsmar, FL

Rx Only

For Institutional Use Only| See Insert

Delivers 30ml

NDC 81033-241-30

LACTULOSE SOLUTION, USP 20 g/35 mL

FOR ORAL OR RECTAL ADMINISTRATION

Store at 20-25°C (68-77°F)

PKG By Kesin Pharma

Oldsmar, FL

Rx Only

For Institutional Use Only

See Insert