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
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 |
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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 |
---|---|---|
Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. | 2003 Dec |
|
Management of hepatic encephalopathy: focus on antibiotic therapy. | 2006 |
|
Carbohydrate preference, acid tolerance and bile tolerance in five strains of Bifidobacterium. | 2006 Apr |
|
[The diagnostics and therapy of hepatic encephalopathy. Recommendations of of the working group on portal hypertension in the Czech Hepatology Society and the J. E. Purkinje Czech Medical Society]. | 2006 Jan |
|
The trans-sialidase from Trypanosoma cruzi triggers apoptosis by target cell sialylation. | 2006 Jul |
|
Direct simultaneous determination of eight sweeteners in foods by capillary isotachophoresis. | 2006 May |
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Prevention of first overt episode of hepatic encephalopathy after TIPS: no easy task. | 2006 May |
|
Molecular mobility and dynamic site heterogeneity in amorphous lactose and lactitol from erythrosin B phosphorescence. | 2006 Sep 20 |
|
Constipation in adults. | 2007 Aug 1 |
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The treatment of hepatic encephalopathy. | 2007 Dec |
|
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 |
|
A study of the properties of tablets from the mixtures of directly compressible starch and directly compressible lactitol. | 2007 Jul |
|
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 |
|
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 |
|
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 Jan 4 |
|
Roles of probiotics and prebiotics in colon cancer prevention: Postulated mechanisms and in-vivo evidence. | 2008 May |
|
Treatment of minimal hepatic encephalopathy. | 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 |
|
The role of rifaximin in the treatment and chemoprophylaxis of travelers' diarrhea. | 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 |
|
Current trends in the treatment of hepatic encephalopathy. | 2009 Jun |
|
Polyols as filler-binders for disintegrating tablets prepared by direct compaction. | 2009 Jun |
|
[Elderly hereditary hemorrhagic telangiectasia female with portosystemic encephalopathy]. | 2009 May |
|
Some putative prebiotics increase the severity of Salmonella enterica serovar Typhimurium infection in mice. | 2009 Nov 30 |
|
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 |
|
Microbial and bioconversion production of D-xylitol and its detection and application. | 2010 Dec 15 |
|
Duodenal administered seal oil for patients with subjective food hypersensitivity: an explorative open pilot study. | 2010 Dec 6 |
|
Gut microbiota in human adults with type 2 diabetes differs from non-diabetic adults. | 2010 Feb 5 |
|
Standards of medical care in diabetes--2010. | 2010 Jan |
|
Synthesis of PEGylated lactose analogs for inhibition studies on T.cruzi trans-sialidase. | 2010 Jul |
|
Constipation in adults. | 2010 Jul 5 |
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Xylo-oligosaccharides and lactitol promote the growth of Bifidobacterium lactis and Lactobacillus species in pure cultures. | 2010 Jun |
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Synbiotic effects of lactitol and Lactobacillus acidophilus NCFM™ in a semi-continuous colon fermentation model. | 2010 Jun |
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Pharmacotherapy for hepatic encephalopathy. | 2010 Jun 18 |
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Recombinant human granulocyte colony stimulating factor pre-screening and screening of stabilizing carbohydrates and polyols. | 2010 Mar 15 |
|
Lactitol or lactulose in the treatment of chronic constipation: result of a systematic. | 2010 Nov |
|
Differences between reversible (self-association) and irreversible aggregation of rHuG-CSF in carbohydrate and polyol formulations. | 2010 Nov |
|
Current and emerging strategies for treating hepatic encephalopathy. | 2010 Sep |
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.
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QA06AD12
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DSLD |
1130 (Number of products:1)
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LACTITOL
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ACTIVE MOIETY
SALT/SOLVATE (PARENT)
SALT/SOLVATE (PARENT)