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 2550%; 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 randomised, double-blind study of polyethylene glycol 4000 and lactulose in the
treatment of constipation in children. 
treatment of chronic constipation in young children... CONCLUSIONS: PEG 4000 has superior efficacy to lactulose for the treatment of
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...
Clinical Trials Related to Generlac (Lactulose)
Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition [Recruiting]
This study will test the influence of lactulose of the human gut microbiota. Healthy
volunteers will ingest 50g of lactulose and donate stool samples 1 day before as well as 1-2
days and 14 days after the test. Using sequencing and metabolomics techniques the
investigators will identify changes in microbiota composition upon lactulose exposure.
Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.) [Withdrawn]
The purpose of this study is to evaluate whether the use of polyethylene glycol is superior
and more safe in treating hepatic encephalopathy compared to lactulose and also to determine
if treatment with polyethylene glycol will reduce the duration of hospital stay.
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation [Not yet recruiting]
Constipation following elective Caesarean sections (CS) is a common problem experienced by
up to 50% of patients (1). The causes for this are multifactorial and include manipulation
of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic
techniques. To try to alleviate the problem of postoperative constipation, some
anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia,
although no data exists that shows whether this has any beneficial effect on postoperative
1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4):
Lactulose Supplementation in Premature Infants [Completed]
A pilot study to test the safety of use of lactulose in preterm infants and to preliminary
assess the hypothesis that lactulose would support the early growth of Lactobacilli in the
stools of premature infants and possibly would also improve nutritional status and decrease
NEC and late-onset sepsis.
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis [Recruiting]
To assess the effects of lactulose for the prevention of first episode of altered sensorium
(hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.
Reports of Suspected Generlac (Lactulose) Side Effects
Chronic Obstructive Pulmonary Disease (12),
OFF Label USE (2),
Lung Disorder (1)