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
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
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 |
DescriptionCurator'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
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.
Approval Year
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | Importal Approved UseIt is recommended for the treatment of occasional constipation, stool regulation and chronic hepatic encephalopathy. |
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Primary | Importal Approved UseIt is recommended for the treatment of occasional constipation, stool regulation and chronic hepatic encephalopathy. |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
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: |
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%) Sources: Abdominal pain (3%) Hypersensitivity reaction Rash 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, 18-88 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%) Other AEs:Diarrhea (1%) Blood creatine phosphokinase increased (1%) Increased blood pressure (1%) Upper respiratory tract infection (9%) Sources: Flatulence (8%) Diarrhea (4%) Blood creatine phosphokinase increased (4%) Abdominal distension (3%) Increased blood pressure (3%) Diarrhea (grade 3, 1%) |
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) Sources: Gastrointestinal symptom NOS (severe, 4 patients) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
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
Title | Date | PubMed |
---|---|---|
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 |
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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 |
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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
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/15294779
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
Edited
Sat Dec 16 16:14:30 GMT 2023
by
admin
on
Sat Dec 16 16:14:30 GMT 2023
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Record UNII |
L2B0WJF7ZY
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Record Status |
Validated (UNII)
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Record Version |
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WHO-VATC |
QA06AD12
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JECFA EVALUATION |
INS-966
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WHO-ATC |
A06AD12
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NCI_THESAURUS |
C283
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CODEX ALIMENTARIUS (GSFA) |
INS-966
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DSLD |
1130 (Number of products:1)
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231323
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L2B0WJF7ZY
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m6659
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CHEMBL296306
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SUB126857
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7970
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585-86-4
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LACTITOL
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C014635
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DTXSID9044247
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100000091655
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157355
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SUB08385MIG
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209-566-5
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DB12942
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L2B0WJF7ZY
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C81025
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Related Record | Type | Details | ||
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SOLVATE->ANHYDROUS | |||
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SOLVATE->ANHYDROUS | |||
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SALT/SOLVATE -> PARENT | |||
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SALT/SOLVATE -> PARENT |
Related Record | Type | Details | ||
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ACTIVE MOIETY |
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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Biological Half-life | PHARMACOKINETIC |
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Tmax | PHARMACOKINETIC |
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SINGLE ORAL DOSE ADMINISTRATION |
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