Lactulose Solution

What is Lactulose Solution?

DESCRIPTION Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15mL contains: Lactulose 10g (less than 1.6g galactose, less than 1.2g lactose, and 0.1g or less of fructose). It also contains D&C Yellow No. 10, FD & C Yellow No. 6 and Purified Water. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-0-ß-D-galactopyranos-D-fructofuranose. It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water. Structure

Uses of Lactulose Solution

Established uses

• 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

How to take Lactulose Solution

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 an

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

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 an

Side effects of Lactulose Solution

Common

• 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.

Warnings and who should not take it

Who should NOT take Lactulose Solution?

• 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 and precautions

• 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.

Overdose

OVERDOSAGE Signs and Symptoms There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated. Oral LD 50 The acute oral LD 50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats. Dialysis Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.

Safety at a glance

Children and elderly

Interactions

Medicine and medicine

• 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.

Frequently asked questions