Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 11 January 2017

Indication(s)

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 therapy reduces the blood ammonia levels by 25-50 %; 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.

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Advisory information

contraindications
CONTRAINDICATIONS Since Generlac Solution (Lactulose Solution, USP) contains galactose (not more than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Special warnings and precautions

PRECAUTIONS General Since Generlac Solution contains galactose (not more than 1.6 g/15 mL) and lactose (not more than 1.2 g/15 mL), it should be used with caution in diabetics.

In the overall management of portal-systemic encephalopathy, it should be recognized that there is serious underlying liver disease with complications such as electrolyte disturbance (e.g., hypokalemia) for which other specific therapy may be required.

Infants receiving lactulose may develop hyponatremia and dehydration.

Drug Interactions There have been conflicting reports about the concomitant use of neomycin and lactulose.

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 Generlac Solution.

Other laxatives should not be used, especially during the initial phase of therapy for portalsystemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate Generlac Solution dosage has been achieved.

Carcinogenesis, Mutagenesis, Impairment of Fertility There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.

There are no known animal data on long-term potential for mutagenicity.

Administration of lactulose in the diet of mice for 18 months in concentrations of 3 % and 10 % (V/W) did not produce any evidence of carcinogenicity.

In studies in mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects on breeding, conception, or parturition.

Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in mice, rats, and rabbits at doses up to 2 or 4 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose.

There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Generlac Solution is administered to a nursing woman.

Pediatric Use Very little information on the use of lactulose in pediatric patients has been recorded (see DOSAGE AND ADMINISTRATION).

Adverse reactions
ADVERSE REACTIONS Precise frequency data are not available. Generlac Solution 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.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Oral Adult The usual adult oral dosage is 30 to 45 mL (2 to 3 tablespoonfuls, containing 20 g to 30 g of Generlac Solution) 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 Generlac Solution 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 Generlac Solution 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 Generlac Solution for this purpose is the same as the recommended daily dose.

Pediatric Very little information on the use of lactulose in pediatric patients 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 pediatric patients, the total daily dose is 40 to 90 mL.

If the initial dose causes diarrhea, the dose should be reduced immediately.

If diarrhea persists, Generlac Solution 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, Generlac Solution may be given as a retention enema via a rectal balloon catheter.

Cleansing enemas containing soapsuds or other alkaline agents should not be used.

Three hundred mL of Generlac Solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes.

Generlac

Solution enema may be repeated every 4 to 6 hours.

If the 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.

Generlac Solution, given orally in the recommended doses, should be started before Generlac Solution by enema is stopped entirely.

Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Generlac Solution is administered to a nursing woman.

Interactions

Drug Interactions There have been conflicting reports about the concomitant use of neomycin and lactulose.

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 Generlac Solution.

Other laxatives should not be used, especially during the initial phase of therapy for portalsystemic encephalopathy, because the loose stools resulting from their use may falsely suggest that adequate Generlac Solution dosage has been achieved.

More information

Category Value
Authorisation number ANDA074603
Agency product number 9U7D5QH5AE
Orphan designation No
Product NDC 60432-038
Date Last Revised 21-01-2014
Type HUMAN PRESCRIPTION DRUG
RXCUI 391937
Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Do Not Freeze Under recommended storage conditions, a normal darkening of color may occur.

Such darkening is characteristic of sugar solutions and does not affect therapeutic action.

Prolonged exposure to temperatures above 30°C (86°F) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable.

If this condition develops, do not use.

Prolonged exposure to freezing temperatures may cause change to a semisolid, too viscous to pour.

Viscosity will return to normal upon warming to room temperature.

Dispense in original container or in a tight, light-resistant container with child-resistant closure as defined in the USP.

To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.

Marketing authorisation holder Morton Grove Pharmaceuticals, Inc.