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Generlac
Overview
What is Generlac?
Generlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration.10 g lactulose (and not more than 1.6 g galactose, not more than 1.2 g lactose, not more than 0.8 g epilactose, and not more than 0.1 g fructose). The pH range is between 2.5 and 6.5.
Generlac Solution is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy.
The chemical name for lactulose is 4---D-galactopyranosyl-D-fructofuranose. It has the following structural formula:
CHO
The molecular weight is 342.30. It is freely soluble in water.
What does Generlac look like?
What are the available doses of Generlac?
Sorry No records found.
What should I talk to my health care provider before I take Generlac?
Sorry No records found
How should I use Generlac?
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.
What interacts with Generlac?
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.
What are the warnings of Generlac?
Magnesium-containing antacids and doxercalciferol injection should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.
What are the precautions of Generlac?
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
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).
What are the side effects of Generlac?
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.
What should I look out for while using Generlac?
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.
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 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 nonfermentable solution. Insufflation of CO as an additional safeguard may be pursued but is considered to be a redundant measure.
What might happen if I take too much Generlac?
How should I store and handle Generlac?
Handling Generlac Solution (Lactulose Solution, USP) is a colorless to yellow, unflavored solution containing 10 g of lactulose/15 mL (667 mg lactulose/mL). It is available in the following container sizes:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Lactulose causes a decrease in blood ammonia concentration and reduces the degree of portal-systemic encephalopathy. These actions are considered to be results of the following:
Experimental data indicate that lactulose is poorly absorbed. Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood. Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours.
When incubated with extracts of human small intestinal mucosa, lactulose was not hydrolyzed during a 24-hour period and did not inhibit the activity of these extracts on lactose. Lactulose reaches the colon essentially unchanged. There it is metabolized by bacteria with the formation of low molecular weight acids that acidify the colon contents.
Non-Clinical Toxicology
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.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 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 nonfermentable solution. Insufflation of CO as an additional safeguard may be pursued but is considered to be a redundant measure.
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.
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.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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