Drug Catalog - Product Detail
LACTULOSE ORAL SOLUTION SOL 10GM/15ML 473ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50383-0779-16 | AKORN | 473 | 10GM/15ML | SOLUTION |
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Description
DESCRIPTION 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 4.8 to 6.0. 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. Chemical Structure
How Supplied
HOW SUPPLIED Lactulose Solution, USP 10 g/15 mL is available as follows: 8 fl oz (237 mL) bottle 16 fl oz (473 mL) bottle 32 fl oz (946 mL) bottle 15 mL unit dose in trays of 10 cups 30 mL unit dose in trays of 10 cups Lactulose solution contains lactulose 667 mg/mL (10 g/15mL). Store at controlled room temperature 15° to 30°C (59° to 86° F). 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. Dispense in original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Rx only Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Rev. 779:08 06/22
Indications & Usage
INDICATIONS 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 and Administration
DOSAGE AND 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.