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
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
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 |
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. |
|||
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 |
---|---|---|
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
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
Fri Dec 15 15:33:21 GMT 2023
by
admin
on
Fri Dec 15 15:33:21 GMT 2023
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Record UNII |
UH2K6W1Y64
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Record Status |
Validated (UNII)
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Record Version |
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-
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C283
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100000090102
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759131
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DTXSID6047028
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DBSALT002935
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1305520
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81025-04-9
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m6659
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C77137
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UH2K6W1Y64
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SUB12097MIG
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Related Record | Type | Details | ||
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PARENT -> SALT/SOLVATE | |||
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ANHYDROUS->SOLVATE |
Related Record | Type | Details | ||
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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Related Record | Type | Details | ||
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ACTIVE MOIETY |