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Lactulose

Generic Name
Lactulose
Brand Names
Constulose, Enulose, Generlac, Kristalose
Drug Type
Small Molecule
Chemical Formula
C12H22O11
CAS Number
4618-18-2
Unique Ingredient Identifier
9XH2P2N8EP

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.

Background

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)

FDA Approved Products

Lactulose Solution
Manufacturer:Rising Pharmaceuticals, Inc.
Route:ORAL, RECTAL
Strength:10 g in 15 mL
Approved: 2023/05/24
NDC:64980-592
Lactulose Solution
Manufacturer:Bajaj Medical, LLC
Route:ORAL, RECTAL
Strength:10 g in 15 mL
Approved: 2022/12/26
NDC:61037-471
Lactulose
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:10 g in 15 mL
Approved: 2009/12/31
NDC:54868-3101
Lactulose
Manufacturer:Fresenius Kabi Austria GmbH
Route:ORAL, RECTAL
Strength:10 g in 15 mL
Approved: 2019/12/31
NDC:18124-002
Lactulose
Manufacturer:Atlantic Biologicals Corps
Route:ORAL
Strength:10 g in 15 mL
Approved: 2021/01/28
NDC:17856-1378

Singapore Approved Products

No Singapore products found for this drug

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