LACTULOSE

Generic: LACTULOSE

Prescription DrugORAL

Drug Information

Brand Name
LACTULOSE
Generic Name
LACTULOSE
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Product Type
Prescription Drug
Route
ORAL
Application Number
0f19e4ed-c90a-4330-a7fa-bf911aa98f09

Pharmacological Class

Osmotic Laxative [EPC]

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.

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 solu...

Read full 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.

Adverse Reactions

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 Pharmaceutical Associates, Inc. at 1-800-845-8210.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

LACTULOSE - Side Effects, Warnings, Uses | FDA Drug Database