Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lactulose Solution is a colorless to amber syrupy liquid. It is available in 15 mL Unit Dose Cups (NDC 68999-002-51) 20 Unit Dose Cups of 15 mL each (NDC 68999-002-24) 30 mL Unit Dose Cups (NDC 68999-004-43) 20 Unit Dose Cups of 30 mL each (NDC 68999-004-24) Lactulose Solution USP contains 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 semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature. Manufactured for: Chartwell Governmental & Specialty RX, LLC. Congers, NY 10920 L72781 Rev: 10/2025; Lactulose Oral Solution, USP 10 g/15 mL - NDC 68999-002-51 - 15 mL Unit Dose Cup Lactulose Oral Solution, USP 20 g/30 mL - NDC 68999-004-43 - 30 mL Unit Dose Cup "Image Description" "Image Description"
- HOW SUPPLIED Lactulose Solution is a colorless to amber syrupy liquid. It is available in 15 mL Unit Dose Cups (NDC 68999-002-51) 20 Unit Dose Cups of 15 mL each (NDC 68999-002-24) 30 mL Unit Dose Cups (NDC 68999-004-43) 20 Unit Dose Cups of 30 mL each (NDC 68999-004-24) Lactulose Solution USP contains 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 semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature. Manufactured for: Chartwell Governmental & Specialty RX, LLC. Congers, NY 10920 L72781 Rev: 10/2025
- Lactulose Oral Solution, USP 10 g/15 mL - NDC 68999-002-51 - 15 mL Unit Dose Cup Lactulose Oral Solution, USP 20 g/30 mL - NDC 68999-004-43 - 30 mL Unit Dose Cup "Image Description" "Image Description"
Overview
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 water. 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. The molecular formula is C 12 H 22 O 11 . It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water. "Image Description"
Indications & Usage
INDICATION AND 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 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.
Contraindications
CONTRAINDICTIONS 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 Chartwell Governmental & Specialty RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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