Lactulose Solution 10 g/15mL
Lactulose Solution USP, 10 g/15 mL · SOLUTION · Kesin Pharma Corporation
Lactulose Solution is a solution containing lactulose solution usp, 10 g/15 ml at 10 g/15mL, taken oral. Manufactured by Kesin Pharma Corporation.
Key Facts
- Brand Name
- Lactulose Solution
- Generic Name
- Lactulose Solution USP, 10 g/15 mL
- NDC Code (Product)
81033-241- Manufacturer
- Kesin Pharma Corporation
- Strength
- 10 g/15mL
- Dosage Form
- SOLUTION
- Route
- ORAL, RECTAL
- Marketing Status
- Application #
- ANDA076645
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 04/16/2021
Recall History
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
VistaPharm, Inc.
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
VistaPharm, Inc.
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
VistaPharm, Inc.
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia level by 25 to 50%; this is generally paralleled by an improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been given for over 2 years in controlled studies.
Dosage & Administration
DOSAGE AND ADMINISTRATION Oral Adult: The usual adult oral dosage is 2 to 3 tablespoonfuls (30 to 45 mL, containing 20 g to 30 g of lactulose) three or four times daily. The dosage may be adjusted every day or two to produce 2 or 3 soft stools daily. Hourly doses of 30 to 45 mL of lactulose may be used to induce the rapid laxation indicated in the initial phase of the therapy of portal-systemic encephalopathy. When the laxative effect has been achieved, the dose of lactulose may then be reduced to the recommended daily dose. Improvement in the patient’s condition may occur within 24 hours but may not begin before 48 hours or even later. Continuous long-term therapy is indicated to lessen the severity and prevent the recurrence of portal-systemic encephalopathy. The dose of lactulose for this purpose is the same as the recommended daily dose. Pediatric: Very little information on the use of lactulose in young children and adolescents has been recorded. As with adults, the subjective goal in proper treatment is to produce 2 to 3 soft stools daily. On the basis of information available, the recommended initial daily oral dose in infants is 2.5 to 10 mL in divided doses. For older chil…
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 There have been conflicting reports about the concomitant use of neomycin and lactulose solution. Theoretically, the elimination of certain colonic bacteria by neomycin and possibly other anti-infective agents may interfere with the desired degradation of lactulose and thus prevent the acidification of colonic contents. Thus the status of the lactulose-treated patient should be closely monitored in the event of concomitant oral anti-infective therapy. 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. Other laxatives should not be used, especially during the initial phase of therapy for portal-systemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate lactulose dosage has been achieved.
Adverse Reactions
ADVERSE REACTIONS Precise frequency data are not available. Lactulose may produce gaseous distention with flatulence or belching and abdominal discomfort such as cramping in about 20% of patients. 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 Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Lactulose Solution used for?
Lactulose Solution contains Lactulose Solution USP, 10 g/15 mL. It is a solution taken oral. Consult your doctor for specific uses.
Is Lactulose Solution a controlled substance?
Lactulose Solution is not classified as a controlled substance by the DEA.
What is the generic name for Lactulose Solution?
The generic name for Lactulose Solution is Lactulose Solution USP, 10 g/15 mL. There are no other listed brand versions of Lactulose Solution USP, 10 g/15 mL.
What is the NDC code for Lactulose Solution 10 g/15mL?
The NDC (National Drug Code) for Lactulose Solution 10 g/15mL is 81033-241, listed by Kesin Pharma Corporation.
Other Lactulose Solution Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)