Lactulose Solution

Lactulose Solution is an FDA-registered drug product whose active ingredient is LACTULOSE SOLUTION USP, 10 G/15 ML. It is labelled by Kesin Pharma Corporation taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 81033-241, application ANDA076645, label effective 20260803. It is one of 3 FDA drug label records sharing the active ingredient LACTULOSE SOLUTION USP, 10 G/15 ML. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LACTULOSE SOLUTION USP, 10 G/15 ML are most often described in connection with: lactulose solution, controlled studies, treatment portal-systemic, encephalopathy including, stages hepatic, therapy reduces, blood ammonia, generally paralleled. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 AND ADMINISTRATION 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 children and adolescents, the total daily dose is 40 to 90 mL. If the initial dose causes diarrhea, the dose should be reduced immediately. If diarrhea persists, lactulose should be discontinued. Rectal When the adult patient is in the impending coma or coma stage of portal-systemic encephalopathy and the danger of aspiration exists, or when the necessary endoscopic or intubation procedures physically interfere with the administration of the recommended oral doses, lactulose solution may be given as a retention enema via a rectal balloon catheter. Cleansing enemas containing soap suds or other alkaline agents should not be used. Three hundred mL of lactulose should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Lactulose enema may be repeated every 4 to 6 hours. If this lactulose enema is inadvertently evacuated too promptly, it may be repeated immediately. The goal of treatment is reversal of the coma stage in order that the patient may be able to take oral medication. Reversal of coma may take place within 2 hours of the first enema in some patients. Lactulose given orally in the recommended doses, should be started before lactulose by enema is stopped entirely.

CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.

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 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 1-656-218-2725 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 3 drug label records with LACTULOSE SOLUTION USP, 10 G/15 ML as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Lactulose Solution used for?
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 …

Who makes Lactulose Solution?
Kesin Pharma Corporation is the labeler of record for Lactulose Solution. 3 FDA label records share the active ingredient LACTULOSE SOLUTION USP, 10 G/15 ML, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Lactulose Solution come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Lactulose Solution prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LACTULOSE SOLUTION USP, 10 G/15 ML?
Yes. 3 FDA drug label records list LACTULOSE SOLUTION USP, 10 G/15 ML as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Lactulose Solution been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.