Lactulose 10 g/15mL
Lactulose · SOLUTION · Xttrium Laboratories, Inc.
Lactulose is a solution containing lactulose at 10 g/15mL, taken oral. Manufactured by Xttrium Laboratories, Inc..
Key Facts
- Brand Name
- Lactulose
- Generic Name
- Lactulose
- NDC Code (Product)
0116-4005- Manufacturer
- Xttrium Laboratories, Inc.
- Strength
- 10 g/15mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075911
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 07/01/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 & 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.
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.
Contraindications
CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Drug Interactions
Drug Interactions Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.
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.
Frequently Asked Questions
What is Lactulose used for?
Lactulose contains Lactulose. It is a solution taken oral. Consult your doctor for specific uses.
Is Lactulose a controlled substance?
Lactulose is not classified as a controlled substance by the DEA.
What is the generic name for Lactulose?
The generic name for Lactulose is Lactulose. There are 7 other brand versions of Lactulose.
What is the NDC code for Lactulose 10 g/15mL?
The NDC (National Drug Code) for Lactulose 10 g/15mL is 0116-4005, listed by Xttrium Laboratories, Inc..