lactulose

FDA Drug Profile — KRISTALOSE, LACTULOSE Crystalline

Drug Details

Generic Name
lactulose
Brand Names
KRISTALOSE, LACTULOSE Crystalline
Application Number
ANDA074712
Sponsor
Cumberland Pharmaceuticals Inc.
NDC Codes
4
Dosage Forms
POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients
LACTULOSE

Indications and 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.

Warnings

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.