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

Molecular Formula	C12H24O11
Molecular Weight	344.3124
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	9 / 9
E/Z Centers	0
Optical Activity	UNSPECIFIED

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 8583	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 8583	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 Health Status: unhealthy Age Group: 18-87 years Sex: M+F 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 Health Status: unhealthy Age Group: 18-88 years Sex: M+F 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 Health Status: healthy Age Group: 23-48 years Sex: M+F 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 Health Status: healthy Age Group: 23-48 years Sex: M+F 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
eMolecules	26985447	https://www.emolecules.com/cgi-bin/more?vid=26985447
MolPort	MolPort-006-069-327	https://www.molport.com/shop/molecule-link/MolPort-006-069-327
ZINC	ZINC000005225520	http://zinc15.docking.org/substances/ZINC000005225520

PubMed

Title	Date	PubMed
Structural changes in natural actomyosin and surimi from ling cod (Ophiodon elongatus) during frozen storage in the absence or presence of cryoprotectants.	2001 Oct	11600013
[Nonabsorbable disaccharides for the treatment of hepatic encephalopathy--a systemic review of randomized clinical trials--a secondary publication].	2005 Jan 10	15697132
Molecular mobility and dynamic site heterogeneity in amorphous lactose and lactitol from erythrosin B phosphorescence.	2006 Sep 20	16730879
Anemia impairs small intestinal absorption measured by intestinal permeability in children.	2007 Jan	17375737
Effects of low doses of lactitol on faecal microflora, pH, short chain fatty acids and gastrointestinal symptomology.	2007 Sep	17623227
Relevance of the diversity among members of the Trypanosoma cruzi trans-sialidase family analyzed with camelids single-domain antibodies.	2008	18949046
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
Polyols as filler-binders for disintegrating tablets prepared by direct compaction.	2009 Jun	19274511
Idiopathic proximal hemimegacolon in an adult woman.	2010 Apr	20535353
Constipation in adults.	2010 Jul 5	21418672

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.

Substance Class	Chemical Created by `admin` on `Wed Apr 02 07:33:15 GMT 2025` Edited by `admin` on `Wed Apr 02 07:33:15 GMT 2025`
Record UNII	L2B0WJF7ZY
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

IMPORTAL

Preferred Name

English

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

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

Classification Tree Code System Code

WHO-VATC

QA06AD12