LACTITOL

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C12H24O11
Molecular Weight	344.3124
Optical Activity	UNSPECIFIED
Defined Stereocenters	9 / 9
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

OC[C@H](O)[C@@H](O)[C@H](O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O)[C@H](O)CO

InChI

InChIKey=VQHSOMBJVWLPSR-JVCRWLNRSA-N

InChI=1S/C12H24O11/c13-1-4(16)7(18)11(5(17)2-14)23-12-10(21)9(20)8(19)6(3-15)22-12/h4-21H,1-3H2/t4-,5+,6+,7+,8-,9-,10+,11+,12-/m0/s1

HIDE SMILES / InChI

Description
Sources: http://www.angelini.it/wps/wcm/connect/it/home/prodotti/farmaci/portolac-polvere-10g
Curator's Comment: description was created based on several sources, including: https://health.mail.ru/drug/importal_n/ | http://www.druginfosys.com/drug.aspx?drugcode=2283&type=1 | https://medikamio.com/fr-ch/medicaments/importal-sachets-de-poudre-10-g/pil | http://www.tabletwise.com/medicine/lactitol-monohydrate

Lactitol is a sugar alcohol. This ingredient has been determined to be GRAS for specified uses as a direct food additive and foods containing lactitol are eligible for a health claim related to dental caries. Lactitol is used as an oral powder or solution in the management of hepatic encephalopathy and in case of short-term treatment of occasional constipation. Intestinal flora of large intestine is metabolize lactitol to low-molecular organic acid, which leads to an increase in osmotic pressure in intestine, increase in volume of fecal masses bowel function normalization. This drug might cause abdominal discomfort, especially flatulence and abdominal pain rarely or sometimes abdominal distension. These effects tend to diminish or disappear after a few days of regular intake of the drug. Since 'antacids and neomycin can neutralize ' acidifying effect of lactitol on stool, they should not be co-administered with lactitol in cirrhotic patients with hepatic encephalopathy; however both substances do not alter the 'laxative effect in patients with constipation.

Originator

Approval Year

Conditions

Condition	Modality	Targets	Highest Phase	Product
Constipation 112 Sources: https://medikamio.com/fr-ch/medicaments/importal-sachets-de-poudre-10-g/pil http://en.pharmacodia.com/web/drug/1_11996.html	Primary		Approved 8429	Importal Approved Use It is recommended for the treatment of occasional constipation, stool regulation and chronic hepatic encephalopathy.
Hepatic encephalopathy 5 Sources: https://health.mail.ru/drug/importal_n/ https://www.ncbi.nlm.nih.gov/pubmed/7569287	Primary		Approved 8429	Importal Approved Use It is recommended for the treatment of occasional constipation, stool regulation and chronic hepatic encephalopathy.

C_max

Value	Dose	Analyte	Population
776 ng/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf	20 g single, oral dose: 20 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL serum	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
2780 ng/mL OTHER GOV https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211281Orig1s000MultidisciplineR.pdf	21 g single, oral dose: 21 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FASTED
776 ng/mL OTHER GOV https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211281Orig1s000MultidisciplineR.pdf	21 g single, oral dose: 21 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: HIGH-FAT

AUC

Value	Dose	Analyte	Population
6.019 ng × h/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf	20 g single, oral dose: 20 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL serum	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
14941 ng × h/mL OTHER GOV https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211281Orig1s000MultidisciplineR.pdf	21 g single, oral dose: 21 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FASTED
6019 ng × h/mL OTHER GOV https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211281Orig1s000MultidisciplineR.pdf	21 g single, oral dose: 21 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: HIGH-FAT

T_1/2

Value	Dose	Analyte	Population
2.4 h DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf	20 g single, oral dose: 20 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL serum	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
2.16 h OTHER GOV https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211281Orig1s000MultidisciplineR.pdf	21 g single, oral dose: 21 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FASTED
2.43 h OTHER GOV https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211281Orig1s000MultidisciplineR.pdf	21 g single, oral dose: 21 g route of administration: Oral experiment type: SINGLE co-administered:	LACTITOL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: HIGH-FAT

Doses

Dose	Population	Adverse events
20 g 1 times / day steady, oral Recommended Dose: 20 g, 1 times / day Route: oral Route: steady Dose: 20 g, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf	unhealthy, 18-87 years n = 298 Health Status: unhealthy Condition: chronic idiopathic constipation Age Group: 18-87 years Sex: M+F Population Size: 298 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf	Other AEs: Urinary tract infection, Abdominal pain... Other AEs: Urinary tract infection (5%) Abdominal pain (3%) Hypersensitivity reaction Rash Pruritus Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf
20 g 1 times / day steady, oral Recommended Dose: 20 g, 1 times / day Route: oral Route: steady Dose: 20 g, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf	unhealthy, 18-88 years n = 291 Health Status: unhealthy Condition: chronic idiopathic constipation Age Group: 18-88 years Sex: M+F Population Size: 291 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf	Disc. AE: Flatulence, Diarrhea... Other AEs: Upper respiratory tract infection, Flatulence... AEs leading to discontinuation/dose reduction: Flatulence (1%) Diarrhea (1%) Blood creatine phosphokinase increased (1%) Increased blood pressure (1%) Other AEs: Upper respiratory tract infection (9%) Flatulence (8%) Diarrhea (4%) Blood creatine phosphokinase increased (4%) Abdominal distension (3%) Increased blood pressure (3%) Diarrhea (grade 3, 1%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf
130 g 1 times / day single, oral Highest studied dose Dose: 130 g, 1 times / day Route: oral Route: single Dose: 130 g, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/3552029/	healthy, 23-48 years n = 21 Health Status: healthy Age Group: 23-48 years Sex: M+F Population Size: 21 Sources: https://pubmed.ncbi.nlm.nih.gov/3552029/	Sources: https://pubmed.ncbi.nlm.nih.gov/3552029/
74 g 1 times / day single, oral MTD Dose: 74 g, 1 times / day Route: oral Route: single Dose: 74 g, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/3552029/	healthy, 23-48 years n = 21 Health Status: healthy Age Group: 23-48 years Sex: M+F Population Size: 21 Sources: https://pubmed.ncbi.nlm.nih.gov/3552029/	DLT: Diarrhea, Gastrointestinal symptom NOS... Dose limiting toxicities: Diarrhea (15 patients) Gastrointestinal symptom NOS (severe, 4 patients) Sources: https://pubmed.ncbi.nlm.nih.gov/3552029/

AEs

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:75323	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:75323
ChemicalBook	CB5363096	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB5363096
ChemicalBook	CB6668853	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB6668853
MolPort	MolPort-006-069-327	https://www.molport.com/shop/molecule-link/MolPort-006-069-327
ZINC	ZINC000005225520	http://zinc15.docking.org/substances/ZINC000005225520
eMolecules	26985447	https://www.emolecules.com/cgi-bin/more?vid=26985447

PubMed

Title	Date	PubMed
Tributyrin and lactitol synergistically enhanced the trophic status of the intestinal mucosa and reduced histamine levels in the gut of nursery pigs.	2002 Mar	11890403
Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties.	2003 Dec	19087388
Comparison of rifaximin and lactitol in the treatment of acute hepatic encephalopathy: results of a randomized, double-blind, double-dummy, controlled clinical trial.	2003 Jan	12480560
Cyclic treatment of chronic hepatic encephalopathy with rifaximin. Results of a double-blind clinical study.	2003 Mar	16481971
Chemoenzymatically synthesized glycoconjugate polymers.	2003 Mar-Apr	12625739
Effect of sugar alcohols on gut function and body composition in normal and cecectomized rats.	2004 Jul	15297710
Oxalate degradation by intestinal lactic acid bacteria in dogs and cats.	2004 Jul 14	15223120
Constipation in adults.	2004 Jun	15652023
Combination of polydextrose and lactitol affects microbial ecosystem and immune responses in rat gastrointestinal tract.	2004 Jun	15182394
Effects of hyperosmolar agents--lactulose, lactitol, sodium phosphate and polyethylene glycol--on cecal coliform bacteria during traditional bowel cleansing: an experimental study in rats.	2004 May-Jun	15178905
Sugar alcohols: what is the evidence for caries-preventive and caries-therapeutic effects?	2004 May-Jun	15153702
Review: lactulose or lactitol may improve hepatic encephalopathy but may be less effective than antibiotics.	2004 Nov-Dec	15518443
Maximum permissive dosage of lactose and lactitol for transitory diarrhea, and utilizable capacity for lactose in Japanese female adults.	2005 Apr	16022189
[Nonabsorbable disaccharides for the treatment of hepatic encephalopathy--a systemic review of randomized clinical trials--a secondary publication].	2005 Jan 10	15697132
Pharmacological prophylaxis of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt: a randomized controlled study.	2005 May	15826716
Short-chain fatty acid formation in the hindgut of rats fed oligosaccharides varying in monomeric composition, degree of polymerisation and solubility.	2005 Nov	16277772
Attenuated response of the serum triglyceride concentration to ingestion of a chocolate containing polydextrose and lactitol in place of sugar.	2005 Oct	16244429
Dietary lactitol fermentation increases circulating peptide YY and glucagon-like peptide-1 in rats and humans.	2005 Oct	16157241
[Intestinal function tests].	2005 Sep 14	16193906
Management of hepatic encephalopathy: focus on antibiotic therapy.	2006	16498257
Carbohydrate preference, acid tolerance and bile tolerance in five strains of Bifidobacterium.	2006 Apr	16553741
Direct simultaneous determination of eight sweeteners in foods by capillary isotachophoresis.	2006 May	16830728
Constipation in adults.	2007 Aug 1	19454117
Effects of lactitol on intestinal microflora and plasma endotoxin in patients with chronic viral hepatitis.	2007 Jan	17049992
[A case of recurrent pneumatosis cystoides intestinalis associated with recurrent pneumoperitoneum].	2007 Sep	17885285
Ecological characterization of the colonic microbiota of normal and diarrheic dogs.	2008	19282974
Relevance of the diversity among members of the Trypanosoma cruzi trans-sialidase family analyzed with camelids single-domain antibodies.	2008	18949046
[Influence of the bifidobacteria and lactitol containing products on lypoperoxidation processes and intestinal microflora].	2008	18505097
Rifaximin for the treatment of hepatic encephalopathy.	2008 Aug	18657018
Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland.	2008 Dec 31	19117521
Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study.	2008 Jan 15	18197974
Xylitol-supplemented nutrition enhances bacterial killing and prolongs survival of rats in experimental pneumococcal sepsis.	2008 Mar 11	18334022
Treatment of minimal hepatic encephalopathy.	2008 Nov	19125944
Intestinal metabolism of weaned piglets fed a typical United States or European diet with or without supplementation of tributyrin and lactitol.	2008 Nov	18502885
Sensory properties and color measurements of dietary chocolates with different compositions during storage for up to 360 days.	2009	22573997
The role of rifaximin in the treatment and chemoprophylaxis of travelers' diarrhea.	2009	19898648
Influence of a combination of Lactobacillus acidophilus NCFM and lactitol on healthy elderly: intestinal and immune parameters.	2009 Feb	18634707
Standards of medical care in diabetes--2009.	2009 Jan	19118286
Some putative prebiotics increase the severity of Salmonella enterica serovar Typhimurium infection in mice.	2009 Nov 30	19948011
Idiopathic proximal hemimegacolon in an adult woman.	2010 Apr	20535353
Successful drug development despite adverse preclinical findings part 2: examples.	2010 Dec	22272032
Microbial and bioconversion production of D-xylitol and its detection and application.	2010 Dec 15	21179590
Duodenal administered seal oil for patients with subjective food hypersensitivity: an explorative open pilot study.	2010 Dec 6	21189836
Standards of medical care in diabetes--2010.	2010 Jan	20042772
Constipation in adults.	2010 Jul 5	21418672
Xylo-oligosaccharides and lactitol promote the growth of Bifidobacterium lactis and Lactobacillus species in pure cultures.	2010 Jun	21840802
Synbiotic effects of lactitol and Lactobacillus acidophilus NCFM™ in a semi-continuous colon fermentation model.	2010 Jun	21840801
Lactitol or lactulose in the treatment of chronic constipation: result of a systematic.	2010 Nov	21510584
Differences between reversible (self-association) and irreversible aggregation of rHuG-CSF in carbohydrate and polyol formulations.	2010 Nov	20854908
Current and emerging strategies for treating hepatic encephalopathy.	2010 Sep	20691385

Patents

Sample Use Guides

In Vivo Use Guide

Initial dose - 20 g at once during 4-5 days. Next, 10 g per day.

Route of Administration: Oral

In Vitro Use Guide

The species of bifidobacteria, which were detected in vessel of each fermentation after adaptation to an Lactitol 1% (wt/vol): Bifidobacterium adolescentis, B. bifidum, B. longum, B. dentium and B. catenulatum. B. angulatum, B. breve and B. infantis were not detected.

Name

Type

Language

LACTITOL

Official Name

English

LACTITOL ANHYDROUS

Common Name

English

LACTOBIOSIT

Common Name

English

MIRUHEN

Common Name

English

LACTITOL ACM 50

Common Name

English

LACTITOL [ORANGE BOOK]

Common Name

English

NSC-231323

Code

English

E-966

Code

English

IMPORTAL

Brand Name

English

4-O-.BETA.-D-GALACTOPYRANOSYL-D-GLUCITOL

Common Name

English

LACTITOL [USP-RS]

Common Name

English

Lactitol [WHO-DD]

Common Name

English

LACTY (SACCHARIDE)

Common Name

English

INS-966

Code

English

D-LACTITOL

Common Name

English

MILCHEN

Common Name

English

LACTITOL [MI]

Common Name

English

LACTOSITOL

Common Name

English

lactitol [INN]

Common Name

English

FINLAC DC

Common Name

English

LACTOSIT

Common Name

English

INS NO.966

Code

English

LACTITOL [INCI]

Common Name

English

Classification Tree Code System Code

WHO-VATC

QA06AD12