Lactulose

Overview

Lactulose is a synthetic disaccharide derivative of lactose that is most commonly used as a laxative agent despite also being formally indicated to serve as an adjunct therapy in treating portal-systemic encephalopathy (PSE). Despite being first synthesized in 1929, investigations regarding its possible use as a laxative for the treatment of chronic constipation did not occur until the 1960s and its first clinical use for treating PSE was not until 1966. Nevertheless, although lactulose received formal FDA approval in 1977 and has since become a readily available generic and brand-name non-prescription medication listed on the World Health Organization's List of Essential Medicines as one of the most effective and safe medicines employed in a health system, data regarding its optimal place in therapy is often ambiguous. Especially considering the use of lactulose as a laxative is typically only considered after lifestyle and dietary modifications fail and the fact that lactulose therapy cannot be ethically withheld from patients diagnosed with PSE in a placebo study, the substance may just be one of many options available for treating constipation and its efficacy in managing PSE may never be formally confirmed or refuted via clinical investigation.

Indication

Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients. Additionally, lactulose is also employed as an adjunct to protein restriction and supportive therapy for the prevention and treatment of portal-systemic encephalopathy (PSE), including both the hepatic pre-coma and coma variations. In particular, lactulose solution has been effective at managing PSE resulting from surgical portacaval shunts or from chronic hepatic diseases like cirrhosis. Moreover, there have also been studies demonstrating the capacity for lactulose to minimize the formation of gallstones and even some investigations regarding the experimental use of the agent in developing novel anticancer agents owing to its ability to bind galactin carbohydrates involved in various tumor progressions .

Associated Conditions

Constipation
Hepatic Encephalopathy (HE)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients	2025/07/15	NCT07065942	Not Applicable	Recruiting	Peking Union Medical College Hospital
A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy.	2025/06/25	NCT07037394	Phase 4	Completed	Qurratul Ain Jamil
Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.	2025/06/04	NCT07002827	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis	2025/02/19	NCT06835361	Phase 2	Recruiting	AVVA Pharmaceuticals Ltd.
Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)	2025/02/04	NCT06808009	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy	2024/12/27	NCT06748638	Phase 4	ENROLLING_BY_INVITATION	Haifeng Lan
Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.	2024/12/17	NCT06738550	Not Applicable	ENROLLING_BY_INVITATION	NIN Institute
BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE	2024/08/05	NCT06538077	Phase 4	Recruiting	Post Graduate Institute of Medical Education and Research, Chandigarh
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)	2024/07/03	NCT06483737	Not Applicable	Recruiting	General Hospital of Shenyang Military Region
Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis	2024/05/13	NCT06411314	Phase 3	Completed	Avva Rus, JSC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
LACTULOSE	Lannett Company, Inc.	0527-5125	ORAL	10 g in 15 mL	1/30/2020
LACTULOSE	Lannett Company, Inc.	0527-5120	ORAL	10 g in 15 mL	7/27/2022
Lactulose	Morton Grove Pharmaceuticals, Inc.	60432-037	ORAL	10 g in 15 mL	11/4/2019
Lactulose	Aidarex Pharmaceuticals LLC	53217-009	ORAL	10 g in 15 mL	10/2/2013
Generlac	Morton Grove Pharmaceuticals, Inc.	60432-038	ORAL, RECTAL	10 g in 15 mL	1/8/2019
LACTULOSE	Pharmaceutical Associates, Inc.	0121-0873	ORAL	10 g in 15 mL	12/21/2022
Lactulose	Xttrium Laboratories, Inc.	0116-4005	ORAL	10 g in 15 mL	3/21/2023
Lactulose	Bio-Pharm, Inc.	59741-249	ORAL	10 g in 15 mL	6/15/2018
LACTULOSE	VistaPharm, Inc.	66689-039	ORAL	10 g in 15 mL	11/19/2020
Lactulose	Chartwell RX, LLC	62135-002	ORAL	10 g in 15 mL	4/5/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DUPHALAC SYRUP	ABBOTT BIOLOGICALS B V	SIN02818P	SYRUP	67 g/100 ml	5/18/1989
LACTUS SYRUP 66% w/v	ICM PHARMA PTE. LTD.	SIN10132P	SYRUP	66% w/v	10/2/1998
LACTUL SOLUTION 670MG/ML	Y.S.P. INDUSTRIES (M) SDN. BHD.	SIN14720P	SOLUTION	670mg/ml	1/12/2015
DHACTULOSE SYRUP	PT Actavis Indonesia	SIN11494P	SYRUP	3.35 g/5 ml	4/25/2001

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Lactulose Oral Solution	青岛黄海制药有限责任公司	国药准字H20249749	化学药品	口服溶液剂	12/17/2024
Lactulose Oral Solution	湖北凯纳药业有限公司	国药准字H20253366	化学药品	口服溶液剂	2/11/2025
Lactulose Oral Solution	重庆健能医药开发有限公司	国药准字H20253369	化学药品	口服溶液剂	2/11/2025
Lactulose Oral Solution	重庆健能医药开发有限公司	国药准字H20253370	化学药品	口服溶液剂	2/11/2025
Lactulose Oral Solution	保定爱晖药业有限公司	国药准字H20249742	化学药品	口服溶液剂	12/17/2024
Lactulose Oral Solution	重庆迈川医药科技有限公司	国药准字H20249795	化学药品	口服溶液剂	12/25/2024
Lactulose Oral Solution	安徽美来药业股份有限公司	国药准字H20253075	化学药品	口服溶液剂	1/8/2025
Lactulose Oral Solution	华萃国际生物科技（广东）有限公司	国药准字H20249305	化学药品	口服溶液剂	11/5/2024
Lactulose Oral Solution	海南万玮制药有限公司	国药准字H20249253	化学药品	口服溶液剂	11/5/2024
Lactulose Oral Solution	河北智恒医药科技股份有限公司	国药准字H20249283	化学药品	口服溶液剂	11/5/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
MARTULOSE SOLUTION 3.35G/5ML	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	11/28/2002

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BLOOMS THE CHEMIST LACTULOSE 667 mg/mL oral liquid bottle	366773	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/21/2021
APOHEALTH LACTULOSE 667 mg/mL oral liquid bottle	337591	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/9/2020
DULOSE lactulose 667 mg/mL oral liquid bottle	220095	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/13/2014
DUPHALAC Lactulose 667mg/mL oral liquid bottle	13295	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/28/1991
CHEMISTS' OWN CONSTIPATION RELIEF SYRUP lactulose 667 mg/mL oral liquid bottle	220096	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/13/2014
ACTILAX lactulose 660 mg/mL oral liquid bottle	43582	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/24/1993

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• A post-hoc analysis revealed that rifaximin monotherapy significantly reduced overt hepatic encephalopathy (OHE) recurrence compared to lactulose monotherapy over 6 months. • Rifaximin demonstrated a longer time to breakthrough OHE episodes and significantly lower all-cause mortality compared to lactulose in patients with cirrhosis. • The study highlights rifaximin as a potential preferred option for secondary prophylaxis of OHE, especially for patients with lactulose intolerance or adherence issues. • Despite the higher cost of rifaximin, its effectiveness in reducing hospital readmissions and improving patient outcomes may offset the initial expense.

Xifaxan Monotherapy Shows Superiority to Lactulose in Reducing Hepatic Encephalopathy Recurrence

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• Analysis of two randomized trials reveals that Xifaxan monotherapy is more effective than lactulose in reducing overt hepatic encephalopathy (OHE) recurrence and mortality. • New data highlights Xifaxan's impact on reducing rehospitalizations for OHE in both commercially insured and Medicare patient populations. • Plenvu's efficacy as a bowel preparation medication is confirmed in colonoscopy patients with comorbid conditions or those on medications affecting bowel prep quality.

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