Drug Catalog - Product Detail
LACTULOSE ORAL (CONSTULOSE) SOL 10GM/15ML 946ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45963-0439-65 | ACTAVIS | 946 | 10GM/15ML | SOLUTION |
PACKAGE FILES
Generic Name
LACTULOSE
Substance Name
LACTULOSE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090503
Description
DESCRIPTION Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). 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: The molecular weight is 342 . 30. It is freely soluble in water. 3bfff862-figure-01
How Supplied
HOW SUPPLIED Lactulose Solution, USP is a natural colored and an unflavored solution available in 8 fl oz (237 mL) and 1 quart (946 mL) bottles. Lactulose Solution, USP contains lactulose 670 mg/mL (10 g/15 mL). Store between 36° to 86°F (2° to 30°C). 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 86°F (30°C) 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 a tight, light-resistant container as defined in the USP, with a child-resistant closure. Manufactured and packaged by: Fresenius Kabi Austria GmbH Estermannstraße 17 4020 Linz, Austria Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 USA Revised – June 2022
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.