Generlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 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.
GENERLAC (Lactulose) is indicated for the following:
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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Published Studies Related to Generlac (Lactulose)
A randomized controlled trial comparing lactulose, probiotics, and L-ornithine L-aspartate in treatment of minimal hepatic encephalopathy. [2011.08]
BACKGROUND: Minimal hepatic encephalopathy (MHE) impairs daily functioning and health-related quality of life (HRQoL). The modalities of treatment of MHE have not been adequately studied. AIMS: To compare lactulose, probiotics, and L-ornithine L-aspartate (LOLA) in treatment of MHE and effect on HRQoL by Sickness Impact Profile questionnaire... CONCLUSION: Lactulose, probiotics, and LOLA significantly improve MHE and HRQoL in patients with chronic liver disease.
Prophylaxis of hepatic encephalopathy in acute variceal bleed: a randomized controlled trial of lactulose versus no lactulose. [2011.06]
BACKGROUND AND AIMS: Acute variceal bleed (AVB) is an important precipitating factor for development of hepatic encephalopathy (HE). However, there is paucity of data on the role of lactulose for prevention of HE after AVB. We evaluated the role of lactulose for prophylaxis of HE after AVB... CONCLUSIONS: Lactulose is effective in prevention of HE in patients with cirrhosis and acute variceal bleed. (c) 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.
Can partially hydrolyzed guar gum be an alternative to lactulose in treatment of childhood constipation? [2010.12]
BACKGROUND/AIMS: In the present study, we aimed to investigate if partially hydrolyzed guar gum (PHGG) can be used safely as a fiber source for treatment of constipation in children and to compare its success with the most commonly used osmotic laxative, lactulose... CONCLUSIONS: Treatment with partially hydrolyzed guar gum is as effective as lactulose treatment in relieving stool withholding and constipation-associated abdominal pain, and its use improves stool consistency. Lactulose seemed to have more side effects, including flatulence and sensation of bad taste.
Gastric emptying and orocaecal transit time of meals containing lactulose or inulin in men. [2010.08]
The H(2) breath test is ideal for orocaecal transit time (OCTT) measurement, as it is non-invasive and inexpensive. Indigestible substrates added to a test meal are metabolised by the colonic bacteria, resulting in the production of H(2) which is detected in end-exhalation breath...
The effects of lactulose supplementation to enteral feedings in premature infants: a pilot study. [2010.02]
OBJECTIVE: To assess the safety and prebiotic effects of lactulose in preterm infants... CONCLUSIONS: This pilot study supports the safety of supplementing preterm infants' feeds with low doses of lactulose. It also demonstrated trends that may suggest positive prebiotic effects. Copyright 2010 Mosby, Inc. All rights reserved.
Clinical Trials Related to Generlac (Lactulose)
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial [Recruiting]
The study will be double blind with respect to rifaximin, and randomization will be
performed using tables of computer-generated random numbers. All subjects will be followed
up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the
Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided
doses so that patient passes 2-3 semisoft stools per day along with placebo . In the
lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three
times a day along with lactulose. Primary endpoints will be recovery of overt HE patients
who will not recover from HE after 10 days will be continued on the same treatment. Total
duration of the study is 1 year.
A Preference Study Comparing Kristalose® and Liquid Lactulose [Not yet recruiting]
This study will evaluate whether patients have an overall preference for Kristalose® or
liquid lactulose based on taste, consistency, and portability.
Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults [Recruiting]
The purpose of this study is to determine the efficacy of a split-dose regimen of
crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as
assessed by the physician's determination of the cleanliness of the colon using the Boston
Bowel Prep Scale (BBPS).
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy [Recruiting]
The purpose of this study is to evaluate the safety and effectiveness of the experimental
drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life [Recruiting]
This study is a randomized, open, parallel group, active comparator, single center trial.
Objectives of the study are hereby given below:
- To study the health related quality of life (HRQOL) in patients with chronic liver
- To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with
chronic liver disease and assessment of HRQOL in patients with MHE.
- To compare the effect of probiotics and lactulose in the treatment of MHE
- To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.
Reports of Suspected Generlac (Lactulose) Side Effects
Chronic Obstructive Pulmonary Disease (12),
OFF Label USE (2),
Lung Disorder (1)