I05770920
R09/20

Rx ONLY

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 FD&C Yellow No. 6, purified water, and flavoring. Sodium hydroxide used to adjust pH. The pH range is 2.5 to 6.5.

Lactulose is a colonic acidifier which promotes laxation.

The chemical name for lactulose is 4-0-ß-D-galactopyranosyl-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.

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 Pharmaceutical Associates, Inc. at 1-800-845-8210.

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.

NDC 0121-0577-08:    8 fl oz (237 mL) bottles
NDC 0121-0577-16:    16 fl oz (473 mL) bottles
NDC 0121-0577-32:    32 fl oz (946 mL) bottle

NDC 0121-4577-15:    15 mL unit dose cup
NDC 0121-4577-40:    Case contains 40 unit dose cups of 15 mL (0121-4577-15) packaged in 4 trays of 10 unit dose cups each.

NDC 0121-4577-06:    Case contains 96 unit dose cups of 15 mL (0121-4577-15) packaged in 6 cartons of 16 unit dose cups each.

NDC 0121-1154-30:    30 mL unit dose cup
NDC 0121-1154-40:    Case contains 40 unit dose cups of 30 mL (0121-1154-30) packaged in 4 trays of 10 unit dose cups each.
NDC 0121-1154-00:    Case contains 100 unit dose cups of 30 mL (0121-1154-30) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1154-06:    Case contains 96 unit dose cups of 30 mL (0121-1154-30) packaged in 6 cartons of 16 unit dose cups each.

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

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

R02/19

NDC 0121-0577-16

Lactulose Solution USP

10 g/15 mL

Each 15 mL 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 FD&C Yellow
No. 6, purified water, and flavoring. Sodium hydroxide
used to adjust pH. The pH range is 2.5 to 6.5.

Dispense in original container or tight, light-resistant
container with a child-resistant closure.

To the Pharmacist: When ordering this product,
include the product number (or NDC) in the
description.

Rx ONLY

16 fl oz (473 mL)

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

UNIT DOSE
Delivers 15 mL
NDC 0121-4577-15

LACTULOSE
SOLUTION USP 10 g/15 mL

Indication: For the treatment
of constipation. See Insert.
FOR INSTITUTIONAL USE ONLY

Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

F45771500

UNIT DOSE
Delivers 30 mL
NDC 0121-1154-30

LACTULOSE
SOLUTION USP 20 g/30 mL

Indication: For the treatment
of constipation. See Insert.
FOR INSTITUTIONAL USE ONLY

Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

A45773001