LACTITOL DIHYDRATE

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C12H24O11.2H2O
Molecular Weight	380.3429
Optical Activity	UNSPECIFIED
Defined Stereocenters	9 / 9
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

O.O.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=VAOUPFUEMFJHKI-MTURKXFLSA-N

InChI=1S/C12H24O11.2H2O/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;2*1H2/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

Molecular Formula	H2O
Molecular Weight	18.0153
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

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
Nonabsorbable disaccharides for hepatic encephalopathy.	2004	15106187
Pharmacological prophylaxis of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt: a randomized controlled study.	2005 May	15826716
Attenuated response of the serum triglyceride concentration to ingestion of a chocolate containing polydextrose and lactitol in place of sugar.	2005 Oct	16244429
[Intestinal function tests].	2005 Sep 14	16193906
Prophylactic antibiotic treatment is superior to therapy on-demand in experimental necrotising pancreatitis.	2008	19014609
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
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
Characteristic fragmentation patterns of the trimethylsilyl and trimethylsilyl-oxime derivatives of various saccharides as obtained by gas chromatography coupled to ion-trap mass spectrometry.	2008 Jan 4	18061601
Xylitol-supplemented nutrition enhances bacterial killing and prolongs survival of rats in experimental pneumococcal sepsis.	2008 Mar 11	18334022
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
Sugar alcohols, caries incidence, and remineralization of caries lesions: a literature review.	2010	20339492
Constipation in adults.	2010 Jul 5	21418672
Lactitol or lactulose in the treatment of chronic constipation: result of a systematic.	2010 Nov	21510584

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 `Mon Mar 31 18:56:23 GMT 2025` Edited by `admin` on `Mon Mar 31 18:56:23 GMT 2025`
Record UNII	1F5S85F60B
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

LACTITOL DIHYDRATE

Common Name

English

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

Preferred Name

English

LACTOSITOL DIHYDRATE

Common Name

English

LACTITOL DIHYDRATE [MI]

Common Name

English

Code System Code Type Description

PUBCHEM

157354