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

Stem definition	Drug id	CAS RN
	4614	9002-92-0

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company	Orphan
March 30, 2010	FDA	CHEMISCH FBRK KRSSLR

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Deep vein thrombosis	228.30	47.01	61	376	83739	63404846
Peripheral vein thrombus extension	54.46	47.01	5	432	0	63488585

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Deep vein thrombosis	92.93	73.33	31	295	65217	34891388

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Deep vein thrombosis	154.34	44.63	50	538	120869	79622931

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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	67850-140	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
Asclera	HUMAN PRESCRIPTION DRUG LABEL	1	67850-141	INJECTION, SOLUTION	0.01 g	INTRAVENOUS	NDA	26 sections