U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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 of LACTITOL

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
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

Curator's Comment: http://www.sugar-and-sweetener-guide.com/lactitol.html

Approval Year

Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Importal

Approved Use

It is recommended for the treatment of occasional constipation, stool regulation and chronic hepatic encephalopathy.
Primary
Importal

Approved Use

It is recommended for the treatment of occasional constipation, stool regulation and chronic hepatic encephalopathy.
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
776 ng/mL
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
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
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

AUC

ValueDoseCo-administeredAnalytePopulation
6.019 ng × h/mL
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
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
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
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
2.4 h
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
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
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

Doses

DosePopulationAdverse 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:
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:
Other AEs: Urinary tract infection, Abdominal pain...
Other AEs:
Urinary tract infection (5%)
Abdominal pain (3%)
Hypersensitivity reaction
Rash
Pruritus
Sources:
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:
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:
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:
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:
healthy, 23-48 years
n = 21
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
Population Size: 21
Sources:
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:
healthy, 23-48 years
n = 21
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
Population Size: 21
Sources:
DLT: Diarrhea, Gastrointestinal symptom NOS...
Dose limiting toxicities:
Diarrhea (15 patients)
Gastrointestinal symptom NOS (severe, 4 patients)
Sources:
AEs

AEs

AESignificanceDosePopulation
Hypersensitivity reaction
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:
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:
Pruritus
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:
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:
Rash
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:
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:
Abdominal pain 3%
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:
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:
Urinary tract infection 5%
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:
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:
Blood creatine phosphokinase increased 1%
Disc. AE
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:
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:
Diarrhea 1%
Disc. AE
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:
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:
Flatulence 1%
Disc. AE
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:
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:
Increased blood pressure 1%
Disc. AE
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:
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:
Abdominal distension 3%
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:
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:
Increased blood pressure 3%
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:
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:
Blood creatine phosphokinase increased 4%
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:
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:
Diarrhea 4%
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:
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:
Flatulence 8%
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:
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:
Upper respiratory tract infection 9%
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:
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:
Diarrhea grade 3, 1%
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:
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:
Diarrhea 15 patients
DLT, Disc. AE
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:
healthy, 23-48 years
n = 21
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
Population Size: 21
Sources:
Gastrointestinal symptom NOS severe, 4 patients
DLT, Disc. AE
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:
healthy, 23-48 years
n = 21
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
Population Size: 21
Sources:
PubMed

PubMed

TitleDatePubMed
Tributyrin and lactitol synergistically enhanced the trophic status of the intestinal mucosa and reduced histamine levels in the gut of nursery pigs.
2002 Mar
Effect of sugar alcohols on gut function and body composition in normal and cecectomized rats.
2004 Jul
Oxalate degradation by intestinal lactic acid bacteria in dogs and cats.
2004 Jul 14
Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials.
2004 May 1
Sugar alcohols: what is the evidence for caries-preventive and caries-therapeutic effects?
2004 May-Jun
Attenuated response of the serum triglyceride concentration to ingestion of a chocolate containing polydextrose and lactitol in place of sugar.
2005 Oct
Dietary lactitol fermentation increases circulating peptide YY and glucagon-like peptide-1 in rats and humans.
2005 Oct
Prevention of first overt episode of hepatic encephalopathy after TIPS: no easy task.
2006 May
The treatment of hepatic encephalopathy.
2007 Dec
Threshold for transitory diarrhea induced by ingestion of xylitol and lactitol in young male and female adults.
2007 Feb
Anemia impairs small intestinal absorption measured by intestinal permeability in children.
2007 Jan
A study of the properties of tablets from the mixtures of directly compressible starch and directly compressible lactitol.
2007 Jul
Ecological characterization of the colonic microbiota of normal and diarrheic dogs.
2008
Rifaximin for the treatment of hepatic encephalopathy.
2008 Aug
Sugar alcohols, caries incidence, and remineralization of caries lesions: a literature review.
2010
Idiopathic proximal hemimegacolon in an adult woman.
2010 Apr
Freeze-drying of proteins with glass-forming oligosaccharide-derived sugar alcohols.
2010 Apr 15
Duodenal administered seal oil for patients with subjective food hypersensitivity: an explorative open pilot study.
2010 Dec 6
Synthesis of PEGylated lactose analogs for inhibition studies on T.cruzi trans-sialidase.
2010 Jul
Patents

Sample Use Guides

Initial dose - 20 g at once during 4-5 days. Next, 10 g per day.
Route of Administration: Oral
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 Sat Dec 16 16:14:30 GMT 2023
Edited
by admin
on Sat Dec 16 16:14:30 GMT 2023
Record UNII
L2B0WJF7ZY
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
LACTITOL
INCI   INN   MI   WHO-DD  
INN   INCI  
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
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
JECFA EVALUATION INS-966
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
WHO-ATC A06AD12
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
NCI_THESAURUS C283
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
CODEX ALIMENTARIUS (GSFA) INS-966
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
DSLD 1130 (Number of products:1)
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
Code System Code Type Description
NSC
231323
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
DAILYMED
L2B0WJF7ZY
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
MERCK INDEX
m6659
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY Merck Index
ChEMBL
CHEMBL296306
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
EVMPD
SUB126857
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
HSDB
7970
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
EU FOOD ADDITIVES
E 966
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
CAS
585-86-4
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
WIKIPEDIA
LACTITOL
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
MESH
C014635
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
EPA CompTox
DTXSID9044247
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
SMS_ID
100000091655
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
PUBCHEM
157355
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
EVMPD
SUB08385MIG
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
ECHA (EC/EINECS)
209-566-5
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
DRUG BANK
DB12942
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
RS_ITEM_NUM
1356687
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
RXCUI
28395
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY RxNorm
FDA UNII
L2B0WJF7ZY
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
INN
6414
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
CHEBI
75323
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
DRUG CENTRAL
1534
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
NCI_THESAURUS
C81025
Created by admin on Sat Dec 16 16:14:31 GMT 2023 , Edited by admin on Sat Dec 16 16:14:31 GMT 2023
PRIMARY
Related Record Type Details
SOLVATE->ANHYDROUS
SOLVATE->ANHYDROUS
SALT/SOLVATE -> PARENT
SALT/SOLVATE -> PARENT
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC
Tmax PHARMACOKINETIC SINGLE ORAL DOSE ADMINISTRATION