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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 of LACTITOL DIHYDRATE

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
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
Health Status: unhealthy
Age Group: 18-87 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
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
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-87 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-87 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-87 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-87 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-87 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: unhealthy
Age Group: 18-88 years
Sex: M+F
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
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
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
Health Status: healthy
Age Group: 23-48 years
Sex: M+F
Sources:
PubMed

PubMed

TitleDatePubMed
Microbial and bioconversion production of D-xylitol and its detection and application.
2010-12-15
Duodenal administered seal oil for patients with subjective food hypersensitivity: an explorative open pilot study.
2010-12-06
Successful drug development despite adverse preclinical findings part 2: examples.
2010-12
Lactitol or lactulose in the treatment of chronic constipation: result of a systematic.
2010-11
Differences between reversible (self-association) and irreversible aggregation of rHuG-CSF in carbohydrate and polyol formulations.
2010-11
Current and emerging strategies for treating hepatic encephalopathy.
2010-09
Constipation in adults.
2010-07-05
Synthesis of PEGylated lactose analogs for inhibition studies on T.cruzi trans-sialidase.
2010-07
Pharmacotherapy for hepatic encephalopathy.
2010-06-18
Xylo-oligosaccharides and lactitol promote the growth of Bifidobacterium lactis and Lactobacillus species in pure cultures.
2010-06
Synbiotic effects of lactitol and Lactobacillus acidophilus NCFM™ in a semi-continuous colon fermentation model.
2010-06
Freeze-drying of proteins with glass-forming oligosaccharide-derived sugar alcohols.
2010-04-15
Idiopathic proximal hemimegacolon in an adult woman.
2010-04
Recombinant human granulocyte colony stimulating factor pre-screening and screening of stabilizing carbohydrates and polyols.
2010-03-15
Gut microbiota in human adults with type 2 diabetes differs from non-diabetic adults.
2010-02-05
Standards of medical care in diabetes--2010.
2010-01
Sugar alcohols, caries incidence, and remineralization of caries lesions: a literature review.
2010
Some putative prebiotics increase the severity of Salmonella enterica serovar Typhimurium infection in mice.
2009-11-30
Suppressive response of confections containing the extractive from leaves of Morus Alba on postprandial blood glucose and insulin in healthy human subjects.
2009-07-14
Current trends in the treatment of hepatic encephalopathy.
2009-06
Polyols as filler-binders for disintegrating tablets prepared by direct compaction.
2009-06
[Elderly hereditary hemorrhagic telangiectasia female with portosystemic encephalopathy].
2009-05
[Prebiotic lactitol as a component of biopreparation from aerobic bacilli].
2009-04-09
Influence of a combination of Lactobacillus acidophilus NCFM and lactitol on healthy elderly: intestinal and immune parameters.
2009-02
Standards of medical care in diabetes--2009.
2009-01
Sensory properties and color measurements of dietary chocolates with different compositions during storage for up to 360 days.
2009
The role of rifaximin in the treatment and chemoprophylaxis of travelers' diarrhea.
2009
Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland.
2008-12-31
Treatment of minimal hepatic encephalopathy.
2008-11
Intestinal metabolism of weaned piglets fed a typical United States or European diet with or without supplementation of tributyrin and lactitol.
2008-11
Rifaximin for the treatment of hepatic encephalopathy.
2008-08
Roles of probiotics and prebiotics in colon cancer prevention: Postulated mechanisms and in-vivo evidence.
2008-05
Xylitol-supplemented nutrition enhances bacterial killing and prolongs survival of rats in experimental pneumococcal sepsis.
2008-03-11
Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study.
2008-01-15
Characteristic fragmentation patterns of the trimethylsilyl and trimethylsilyl-oxime derivatives of various saccharides as obtained by gas chromatography coupled to ion-trap mass spectrometry.
2008-01-04
Ecological characterization of the colonic microbiota of normal and diarrheic dogs.
2008
Prophylactic antibiotic treatment is superior to therapy on-demand in experimental necrotising pancreatitis.
2008
Relevance of the diversity among members of the Trypanosoma cruzi trans-sialidase family analyzed with camelids single-domain antibodies.
2008
[Influence of the bifidobacteria and lactitol containing products on lypoperoxidation processes and intestinal microflora].
2008
The treatment of hepatic encephalopathy.
2007-12
The trans-sialidase from Trypanosoma cruzi efficiently transfers alpha-(2-->3)-linked N-glycolylneuraminic acid to terminal beta-galactosyl units.
2007-11-26
Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a pilot study.
2007-09-04
[A case of recurrent pneumatosis cystoides intestinalis associated with recurrent pneumoperitoneum].
2007-09
Effects of low doses of lactitol on faecal microflora, pH, short chain fatty acids and gastrointestinal symptomology.
2007-09
Constipation in adults.
2007-08-01
A study of the properties of tablets from the mixtures of directly compressible starch and directly compressible lactitol.
2007-07
Characterization of the bga1-encoded glycoside hydrolase family 35 beta-galactosidase of Hypocrea jecorina with galacto-beta-D-galactanase activity.
2007-04
Threshold for transitory diarrhea induced by ingestion of xylitol and lactitol in young male and female adults.
2007-02
Anemia impairs small intestinal absorption measured by intestinal permeability in children.
2007-01
Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties.
2003-12
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 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
  • Download
Name Type Language
LACTITOL DIHYDRATE
MI  
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
Created by admin on Mon Mar 31 18:56:23 GMT 2025 , Edited by admin on Mon Mar 31 18:56:23 GMT 2025
PRIMARY
FDA UNII
1F5S85F60B
Created by admin on Mon Mar 31 18:56:23 GMT 2025 , Edited by admin on Mon Mar 31 18:56:23 GMT 2025
PRIMARY
EPA CompTox
DTXSID80230863
Created by admin on Mon Mar 31 18:56:23 GMT 2025 , Edited by admin on Mon Mar 31 18:56:23 GMT 2025
PRIMARY
MERCK INDEX
m6659
Created by admin on Mon Mar 31 18:56:23 GMT 2025 , Edited by admin on Mon Mar 31 18:56:23 GMT 2025
PRIMARY Merck Index
CAS
81025-03-8
Created by admin on Mon Mar 31 18:56:23 GMT 2025 , Edited by admin on Mon Mar 31 18:56:23 GMT 2025
PRIMARY
Related Record Type Details
PARENT -> SALT/SOLVATE
ANHYDROUS->SOLVATE