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

Stem definitionDrug idCAS RN
4614 9002-92-0

Description:

MoleculeDescription

Synonyms:

  • polidocanol
  • asclera
  • varithena
  • Laureth-9
  • polyethylene glycol monododecyl ether
  • aethoxysklerol
An alkyl polyglycol ether of LAURYL ALCOHOL, chemically defined as an alcohol ethoxylate having an average alkyl chain of 12–14 carbon atoms, and an ethylene oxide chain of 9 ethylene oxide units. It is used as a detergent, and medically as a local anesthetic, and as a sclerosing agent for the treatment of ESOPHAGEAL AND GASTRIC VARICES and VARICOSE VEINS.
  • Molecular weight:
  • Formula: C2H16O11(C2H4O)n
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 30, 2010 FDA CHEMISCH FBRK KRSSLR

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
Deep vein thrombosis 227.88 45.41 60 335 76917 56214755
Peripheral vein thrombus extension 54.37 45.41 5 390 0 56291672
Skin discolouration 47.48 45.41 15 380 34341 56257331

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
Deep vein thrombosis 88.53 67.77 30 292 60706 31636316

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
Deep vein thrombosis 147.76 43.38 48 504 110994 70816898

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C05BB02 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
ANTIVARICOSE THERAPY
Sclerosing agents for local injection
FDA PE N0000009905 Vascular Sclerosing Activity
FDA MoA N0000020024 Sclerosing Activity
MeSH PA D002317 Cardiovascular Agents
MeSH PA D003902 Detergents
MeSH PA D019999 Pharmaceutical Solutions
MeSH PA D012597 Sclerosing Solutions
MeSH PA D013501 Surface-Active Agents
FDA EPC N0000175814 Sclerosing Agent
CHEBI has role CHEBI:38828 non-ionic surfactant
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:63923 sclerotherapy agents

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

DiseaseRelationSNOMED_IDDOID
Venous varices indication 128060009 DOID:799




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
180MG/18ML (10MG/ML) VARITHENA PROVENSIS N205098 Nov. 25, 2013 RX SOLUTION INTRAVENOUS 7731986 Nov. 17, 2024 A METHOD OF INTRAVENOUS INJECTION USING ULTRASOUND GUIDANCE, ADMINISTERED VIA A SINGLE CANNULA INTO THE LUMEN OF THE TARGET INCOMPETENT TRUNK VEINS OR BY DIRECT INJECTION INTO VARICOSITIES
180MG/18ML (10MG/ML) VARITHENA PROVENSIS N205098 Nov. 25, 2013 RX SOLUTION INTRAVENOUS 7814943 Nov. 19, 2027 A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D01993 KEGG_DRUG
4031333 VUID
N0000184324 NUI
4018563 VANDF
4031333 VANDF
CHEBI:46859 CHEBI
CHEMBL1231723 ChEMBL_ID
1562 INN_ID
DB06811 DRUGBANK_ID
0AWH8BFG9A UNII
1484399 RXNORM
185389 MMSL
21617 MMSL
229664 MMSL
d05824 MMSL
006261 NDDF
010700 NDDF
013940 NDDF
427905004 SNOMEDCT_US
427906003 SNOMEDCT_US
C0071330 UMLSCUI
D000077423 MESH_DESCRIPTOR_UI
CHEMBL2108373 ChEMBL_ID
656641 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Asclera HUMAN PRESCRIPTION DRUG LABEL 1 46783-121 INJECTION, SOLUTION 0.01 g INTRAVENOUS NDA 26 sections
Asclera HUMAN PRESCRIPTION DRUG LABEL 1 46783-221 INJECTION, SOLUTION 0.01 g INTRAVENOUS NDA 26 sections
Asclera HUMAN PRESCRIPTION DRUG LABEL 1 67850-140 INJECTION, SOLUTION 0.01 g INTRAVENOUS NDA 26 sections
Asclera HUMAN PRESCRIPTION DRUG LABEL 1 67850-141 INJECTION, SOLUTION 0.01 g INTRAVENOUS NDA 26 sections