lactitol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1534 585-86-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pizensy
  • lactitol
  • lactite
  • lactiobiosit
  • lactositol
  • Molecular weight: 344.31
  • Formula: C12H24O11
  • CLOGP: -4.23
  • LIPINSKI: 2
  • HAC: 11
  • HDO: 9
  • TPSA: 200.53
  • ALOGS: 0.04
  • ROTB: 8

  • Status: OFM

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 g O

ADMET properties:

PropertyValueReference
S (Water solubility) 667 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Feb. 12, 2020 FDA BRAINTREE LABS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hepatic encephalopathy 42.00 40.44 11 499 11271 63477241

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hepatic encephalopathy 43.53 40.83 12 276 14673 34941970

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hepatic encephalopathy 80.80 33.49 23 830 24143 79719392

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A06AD12 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Osmotically acting laxatives
FDA PE N0000009875 Stimulation Small Intestine Fluid/Electrolyte Secretion
FDA MoA N0000010288 Osmotic Activity
MeSH PA D002400 Cathartics
MeSH PA D005421 Flavoring Agents
MeSH PA D005503 Food Additives
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D013549 Sweetening Agents
FDA EPC N0000175811 Osmotic Laxative
CHEBI has role CHEBI:50503 laxante
CHEBI has role CHEBI:75324 excipient
CHEBI has role CHEBI:75325 cathartics

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic idiopathic constipation indication 82934008
Gastrointestinal obstruction contraindication 126765001
Galactosemia contraindication 190745006 DOID:9870




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.27 acidic
pKa2 13.48 acidic
pKa3 13.97 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10GM PIZENSY BRAINTREE LABS N211281 Feb. 12, 2020 DISCN FOR SOLUTION ORAL 10806743 May 12, 2037 METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10GM PIZENSY BRAINTREE LABS N211281 Feb. 12, 2020 DISCN FOR SOLUTION ORAL Feb. 12, 2025 NEW CHEMICAL ENTITY

Bioactivity Summary:

None

External reference:

IDSource
D08266 KEGG_DRUG
C0064585 UMLSCUI
CHEBI:75323 CHEBI
CHEMBL1661 ChEMBL_ID
DB12942 DRUGBANK_ID
C014635 MESH_SUPPLEMENTAL_RECORD_UI
157355 PUBCHEM_CID
6414 INN_ID
L2B0WJF7ZY UNII
2284606 RXNORM
23072 MMSL
d06357 MMSL
003987 NDDF
317599009 SNOMEDCT_US
418929008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PIZENSY HUMAN PRESCRIPTION DRUG LABEL 1 52268-600 POWDER, FOR SOLUTION 1 g ORAL NDA 15 sections