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

Details

Stereochemistry ABSOLUTE
Molecular Formula C12H24O11.H2O
Molecular Weight 362.3276
Optical Activity UNSPECIFIED
Defined Stereocenters 9 / 9
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of LACTITOL MONOHYDRATE

SMILES

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=LXMBXZRLTPSWCR-XBLONOLSSA-N
InChI=1S/C12H24O11.H2O/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;1H2/t4-,5+,6+,7+,8-,9-,10+,11+,12-;/m0./s1

HIDE SMILES / InChI

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

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
Lactitol or lactulose in the treatment of chronic hepatic encephalopathy: results of a meta-analysis.
1992 Feb
Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties.
2003 Dec
Cyclic treatment of chronic hepatic encephalopathy with rifaximin. Results of a double-blind clinical study.
2003 Mar
Nonabsorbable disaccharides for hepatic encephalopathy.
2004
Lactose derivatives are inhibitors of Trypanosoma cruzi trans-sialidase activity toward conventional substrates in vitro and in vivo.
2004 Jul
Oxalate degradation by intestinal lactic acid bacteria in dogs and cats.
2004 Jul 14
Constipation in adults.
2004 Jun
Sugar alcohols: what is the evidence for caries-preventive and caries-therapeutic effects?
2004 May-Jun
Pharmacological prophylaxis of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt: a randomized controlled study.
2005 May
Short-chain fatty acid formation in the hindgut of rats fed oligosaccharides varying in monomeric composition, degree of polymerisation and solubility.
2005 Nov
Attenuated response of the serum triglyceride concentration to ingestion of a chocolate containing polydextrose and lactitol in place of sugar.
2005 Oct
Management of hepatic encephalopathy: focus on antibiotic therapy.
2006
Carbohydrate preference, acid tolerance and bile tolerance in five strains of Bifidobacterium.
2006 Apr
Direct simultaneous determination of eight sweeteners in foods by capillary isotachophoresis.
2006 May
Characterization of the bga1-encoded glycoside hydrolase family 35 beta-galactosidase of Hypocrea jecorina with galacto-beta-D-galactanase activity.
2007 Apr
Constipation in adults.
2007 Aug 1
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
Effects of lactitol on intestinal microflora and plasma endotoxin in patients with chronic viral hepatitis.
2007 Jan
The trans-sialidase from Trypanosoma cruzi efficiently transfers alpha-(2-->3)-linked N-glycolylneuraminic acid to terminal beta-galactosyl units.
2007 Nov 26
Effects of low doses of lactitol on faecal microflora, pH, short chain fatty acids and gastrointestinal symptomology.
2007 Sep
Suppressive effect of partially hydrolyzed guar gum on transitory diarrhea induced by ingestion of maltitol and lactitol in healthy humans.
2007 Sep
Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a pilot study.
2007 Sep 4
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
Rifaximin for the treatment of hepatic encephalopathy.
2008 Aug
Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland.
2008 Dec 31
Roles of probiotics and prebiotics in colon cancer prevention: Postulated mechanisms and in-vivo evidence.
2008 May
Treatment of minimal hepatic encephalopathy.
2008 Nov
Intestinal metabolism of weaned piglets fed a typical United States or European diet with or without supplementation of tributyrin and lactitol.
2008 Nov
[Prebiotic lactitol as a component of biopreparation from aerobic bacilli].
2008 Nov-Dec
Sensory properties and color measurements of dietary chocolates with different compositions during storage for up to 360 days.
2009
Influence of a combination of Lactobacillus acidophilus NCFM and lactitol on healthy elderly: intestinal and immune parameters.
2009 Feb
Standards of medical care in diabetes--2009.
2009 Jan
Suppressive response of confections containing the extractive from leaves of Morus Alba on postprandial blood glucose and insulin in healthy human subjects.
2009 Jul 14
Polyols as filler-binders for disintegrating tablets prepared by direct compaction.
2009 Jun
[Elderly hereditary hemorrhagic telangiectasia female with portosystemic encephalopathy].
2009 May
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
Successful drug development despite adverse preclinical findings part 2: examples.
2010 Dec
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
Xylo-oligosaccharides and lactitol promote the growth of Bifidobacterium lactis and Lactobacillus species in pure cultures.
2010 Jun
Synbiotic effects of lactitol and Lactobacillus acidophilus NCFM™ in a semi-continuous colon fermentation model.
2010 Jun
Pharmacotherapy for hepatic encephalopathy.
2010 Jun 18
Lactitol or lactulose in the treatment of chronic constipation: result of a systematic.
2010 Nov
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 Fri Dec 15 15:33:21 GMT 2023
Edited
by admin
on Fri Dec 15 15:33:21 GMT 2023
Record UNII
UH2K6W1Y64
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
LACTITOL MONOHYDRATE
EP   II   MI   WHO-DD  
Common Name English
LACTITOL HYDRATE [JAN]
Common Name English
D-LACTITOL MONOHYDRATE
Common Name English
BLI-400
Code English
D-GLUCITOL, 4-O-.BETA.-D-GALACTOPYRANOSYL-, MONOHYDRATE
Common Name English
NSC-759131
Code English
Lactitol monohydrate [WHO-DD]
Common Name English
LACTITOL MONOHYDRATE [EP MONOGRAPH]
Common Name English
PIZENSY
Brand Name English
LACTITOL MONOHYDRATE [MI]
Common Name English
LACTITOL MONOHYDRATE [II]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C283
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
Code System Code Type Description
SMS_ID
100000090102
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
NSC
759131
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
DAILYMED
UH2K6W1Y64
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
EPA CompTox
DTXSID6047028
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
DRUG BANK
DBSALT002935
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
RXCUI
1305520
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY RxNorm
PUBCHEM
3067270
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
CAS
81025-04-9
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
MERCK INDEX
m6659
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY Merck Index
NCI_THESAURUS
C77137
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
FDA UNII
UH2K6W1Y64
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
EVMPD
SUB12097MIG
Created by admin on Fri Dec 15 15:33:21 GMT 2023 , Edited by admin on Fri Dec 15 15:33:21 GMT 2023
PRIMARY
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