Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lactulose Solution, USP 10 g/15 mL is a colorless to yellow, unflavored solution available in the following container sizes: 15 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-15) 30 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-30) 8 fl. oz. (237 mL) white bottles (NDC 0116-4005-08) 16 fl. oz. (473 mL) white bottles (NDC 0116-4005-16) 32 fl. oz. (946 mL) white bottles (NDC 0116-4005-32) Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL). Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. Do not freeze. 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 30 °C (86 °F) 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 original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure. To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.; Lactulose 8-oz Label NDC 0116-4005-08 LACTULOSE SOLUTION, USP 10g/15mL INDICATIONS : For the Treatment of Constipation 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). USUAL ADULT DOSAGE: 1 to 2 tablespoonfuls (15 to 30 mL) daily. See attached insert for full prescribing information. 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 a normal bowel movement. Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water, or milk. Dispense in original container or in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Product may darken slightly but therapeutic action is not affected. Do not use if extreme darkening or turbidity occurs. See accompanying product information. Keep tightly closed. PHARMACIST: When ordering this product, include the NDC number in the description. Distributed by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 Rx Only Net Contents: 8 fl oz (237mL) 4005LACT08LBLA Rev. 06/2024 8oz bottle 8oz bottle 8oz bottle; Lactulose 16-oz Label NDC 0116-4005-16 LACTULOSE SOLUTION, USP 10g/15mL INDICATIONS : For the Treatment of Constipation 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). USUAL ADULT DOSAGE: 1 to 2 tablespoonfuls (15 to 30 mL) daily. See attached insert for full prescribing information. 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 a normal bowel movement. Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water, or milk. Dispense in original container or in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Product may darken slightly but therapeutic action is not affected. Do not use if extreme darkening or turbidity occurs. See accompanying product information. Keep tightly closed. PHARMACIST: When ordering this product, include the NDC number in the description. Distributed by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 Rx Only Net Contents: 16 fl oz (473mL) 4005LACT16LBLA Rev. 06/2024 16oz bottle 16oz bottle 16oz bottle; Lactulose 32-oz Label NDC 0116-4005-32 LACTULOSE SOLUTION, USP 10g/15mL INDICATIONS: For the Treatment of Constipation 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). USUAL ADULT DOSAGE : 1 to 2 tablespoonfuls (15 to 30 mL) daily. See attached insert for full prescribing information. 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 a normal bowel movement. Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water, or milk. Dispense in original container or in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Product may darken slightly but therapeutic action is not affected. Do not use if extreme darkening or turbidity occurs. See accompanying product information. Keep tightly closed. PHARMACIST: When ordering this product, include the NDC number in the description. Distributed by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 Rx Only Net Contents: 32 fl oz (946 mL) 4005LACT32LBLA Rev. 06/2024 32 oz bottle 32 oz bottle 32 oz bottle; LACTULOSE 15mL UNIT DOSE CUP UNIT DOSE Delivers 15mL NDC 0116-4005-15 LACTULOSE SOLUTION, USP 10g/15mL Rx Only Xttrium Laboratories, Inc. Mount Prospect, IL 60056 4005LACT15LIDA 15 ml lid; LACTULOSE 30 mL UNIT DOSE CUP UNIT DOSE Delivers 30mL NDC 0116-4005-30 LACTULOSE SOLUTION, USP 20g/30mL Rx Only Xttrium Laboratories, Inc. 4005LACT30LIDA 30 ml lid
- HOW SUPPLIED Lactulose Solution, USP 10 g/15 mL is a colorless to yellow, unflavored solution available in the following container sizes: 15 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-15) 30 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-30) 8 fl. oz. (237 mL) white bottles (NDC 0116-4005-08) 16 fl. oz. (473 mL) white bottles (NDC 0116-4005-16) 32 fl. oz. (946 mL) white bottles (NDC 0116-4005-32) Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL). Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. Do not freeze. 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 30 °C (86 °F) 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 original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure. To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.
- Lactulose 8-oz Label NDC 0116-4005-08 LACTULOSE SOLUTION, USP 10g/15mL INDICATIONS : For the Treatment of Constipation 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). USUAL ADULT DOSAGE: 1 to 2 tablespoonfuls (15 to 30 mL) daily. See attached insert for full prescribing information. 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 a normal bowel movement. Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water, or milk. Dispense in original container or in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Product may darken slightly but therapeutic action is not affected. Do not use if extreme darkening or turbidity occurs. See accompanying product information. Keep tightly closed. PHARMACIST: When ordering this product, include the NDC number in the description. Distributed by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 Rx Only Net Contents: 8 fl oz (237mL) 4005LACT08LBLA Rev. 06/2024 8oz bottle 8oz bottle 8oz bottle
- Lactulose 16-oz Label NDC 0116-4005-16 LACTULOSE SOLUTION, USP 10g/15mL INDICATIONS : For the Treatment of Constipation 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). USUAL ADULT DOSAGE: 1 to 2 tablespoonfuls (15 to 30 mL) daily. See attached insert for full prescribing information. 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 a normal bowel movement. Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water, or milk. Dispense in original container or in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Product may darken slightly but therapeutic action is not affected. Do not use if extreme darkening or turbidity occurs. See accompanying product information. Keep tightly closed. PHARMACIST: When ordering this product, include the NDC number in the description. Distributed by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 Rx Only Net Contents: 16 fl oz (473mL) 4005LACT16LBLA Rev. 06/2024 16oz bottle 16oz bottle 16oz bottle
- Lactulose 32-oz Label NDC 0116-4005-32 LACTULOSE SOLUTION, USP 10g/15mL INDICATIONS: For the Treatment of Constipation 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). USUAL ADULT DOSAGE : 1 to 2 tablespoonfuls (15 to 30 mL) daily. See attached insert for full prescribing information. 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 a normal bowel movement. Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water, or milk. Dispense in original container or in a tight, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Product may darken slightly but therapeutic action is not affected. Do not use if extreme darkening or turbidity occurs. See accompanying product information. Keep tightly closed. PHARMACIST: When ordering this product, include the NDC number in the description. Distributed by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 Rx Only Net Contents: 32 fl oz (946 mL) 4005LACT32LBLA Rev. 06/2024 32 oz bottle 32 oz bottle 32 oz bottle
- LACTULOSE 15mL UNIT DOSE CUP UNIT DOSE Delivers 15mL NDC 0116-4005-15 LACTULOSE SOLUTION, USP 10g/15mL Rx Only Xttrium Laboratories, Inc. Mount Prospect, IL 60056 4005LACT15LIDA 15 ml lid
- LACTULOSE 30 mL UNIT DOSE CUP UNIT DOSE Delivers 30mL NDC 0116-4005-30 LACTULOSE SOLUTION, USP 20g/30mL Rx Only Xttrium Laboratories, Inc. 4005LACT30LIDA 30 ml lid
Overview
Lactulose solution is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose 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 water, D&C Yellow No. 10, and FD&C Yellow No. 6. The pH range is 2.5 to 6.5. Lactulose solution is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-ß-D-galactopyranosyl-D-fructofuranose. It has the following structural formula: C 12 H 22 0 11 The molecular weight is 342.30. It is freely soluble in water. structure
Indications & Usage
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.
Dosage & Administration
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.
Warnings & Precautions
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 CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.
Contraindications
Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Adverse Reactions
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 Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
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