LACTULOSE SOLUTION, USP

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 of other sugars). Also contains FD&C Yellow No. 6, purified water, USP and wild cherry flavoring. A minimal quantity of sodium hydroxide, NF is used to adjust pH when necessary. The pH range is 2.5 to 6.5.

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:

C₁₂H₂₂O₁₁

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 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.

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.

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 is available as a cherry-flavored solution, 10 g/15 mL, supplied as follows:

NDC 66689-039-01: 15 mL unit dose cup.

NDC 66689-039-50: Case contains 50 unit dose cups of 15 mL (66689-039-01), packaged in 5 trays of 10 unit dose cups each.

Lactulose Solution is available as a cherry-flavored solution, 20 g/30 mL, supplied as follows:

NDC 66689-038-01: 30 mL unit dose cup.

NDC 66689-038-50: Case contains 50 unit dose cups of 30 mL (66689-038-01), packaged in 5 trays of 10 unit dose cups each.

NDC 66689-038-99: Case contains 100 unit dose cups of 30 mL (66689-038-01), packaged in 10 trays of 10 unit dose cups each.

Lactulose Solution contains lactulose 667 mg/mL (10 g/15 mL).

When ordering this product, include the product code number or NDC in the description.

Rx Only. Keep this and all drugs out of the reach of children.

Manufactured by:
VistaPharm
Largo, FL 33771

VP2051R2
10/19

Xact DOSE™

LACTULOSE
SOLUTION, USP
20 g/30 mL

NDC 66689-038-01

INDICATIONS AND DOSAGE: For the
treatment of constipation. See insert.
Avoid subfreezing temperatures.
Store at 20°–25°C (68°–77°F)
[See USP CONTROLLED RM TEMP]

Rx Only     This cup delivers 30 mL    VP2050

Manufactured by VistaPharm, Inc.
Largo, FL 33771

Xact DOSE™

LACTULOSE
SOLUTION, USP
10 g/15 mL

NDC 66689-039-01

INDICATIONS AND DOSAGE: For the
treatment of constipation. See insert.
Avoid subfreezing temperatures.
Store at 20°–25°C (68°–77°F)
[See USP CONTROLLED RM TEMP]

Rx Only     This cup delivers 15 mL    VP2049

Manufactured by VistaPharm, Inc.
Largo, FL 33771