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

Stem definition	Drug id	CAS RN
	2097	37300-21-3

Description:

Molecule	Description
Synonyms: elmiron pentosan polysulfate xylan polysulfate xylan sulfate xylofuranan sulfate pentosan polysulfate sodium	A sulfated pentosyl polysaccharide with heparin-like properties. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

elmiron
pentosan polysulfate
xylan polysulfate
xylan sulfate
xylofuranan sulfate
pentosan polysulfate sodium

A sulfated pentosyl polysaccharide with heparin-like properties.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.30	g	O

ADMET properties:

Property	Value	Reference
BA (Bioavailability)	3 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Sept. 26, 1996	FDA	JANSSEN PHARMS

FDA Adverse Event Reporting System (Female)

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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
Maculopathy	1459.87	18.18	225	3424	2037	63483336
Dry age-related macular degeneration	257.19	18.18	37	3612	191	63485182
Retinal pigmentation	141.80	18.18	20	3629	87	63485286
Retinal dystrophy	95.46	18.18	12	3637	15	63485358
Cystitis interstitial	87.69	18.18	20	3629	1588	63483785
Age-related macular degeneration	79.33	18.18	16	3633	707	63484666
Colon dysplasia	65.15	18.18	10	3639	85	63485288
Off label use	63.56	18.18	127	3522	674335	62811038
Macular degeneration	63.43	18.18	30	3619	24346	63461027
Eyelid exfoliation	59.10	18.18	10	3639	164	63485209

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FDA Adverse Event Reporting System (Male)

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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
Thermophobia	69.51	32.87	9	749	59	34956114
Adrenocorticotropic hormone deficiency	64.56	32.87	12	746	935	34955238
Hypopituitarism	37.93	32.87	9	749	2273	34953900
Anal ulcer	34.34	32.87	7	751	879	34955294
Maculopathy	33.88	32.87	7	751	939	34955234

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FDA Adverse Event Reporting System (Geriatric)

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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
Maculopathy	1107.03	19.90	177	3447	2648	79738116
Dry age-related macular degeneration	186.16	19.90	28	3596	267	79740497
Retinal pigmentation	138.74	19.90	19	3605	85	79740679
Cystitis interstitial	101.17	19.90	21	3603	1362	79739402
Age-related macular degeneration	84.25	19.90	17	3607	957	79739807
Macular degeneration	72.74	19.90	25	3599	11271	79729493
Thermophobia	62.81	19.90	9	3615	59	79740705
Eyelid exfoliation	62.80	19.90	10	3614	142	79740622
Retinal dystrophy	59.75	19.90	8	3616	29	79740735
Colon dysplasia	58.84	19.90	10	3614	216	79740548

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C05BA04	CARDIOVASCULAR SYSTEM VASOPROTECTIVES ANTIVARICOSE THERAPY Heparins or heparinoids for topical use
ATC	G04BX15	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Other urologicals
FDA CS	M0009496	Glycosaminoglycans
FDA EPC	N0000175837	Glycosaminoglycan
MeSH PA	D000925	Anticoagulants
MeSH PA	D006401	Hematologic Agents

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

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Disease	Relation	SNOMED_ID	DOID
Bladder pain	indication	15803009
Ulcerative cystitis	indication	111409009	DOID:13949
Urinary Tract Irritation	indication
Gastrointestinal ulcer	contraindication	40845000
Blood coagulation disorder	contraindication	64779008	DOID:1247
Heparin-induced thrombocytopenia	contraindication	73397007
Hemophilia	contraindication	90935002
Bleeding	contraindication	131148009
Arterial aneurysm	contraindication	233981004
Disease of liver	contraindication	235856003	DOID:409

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

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ID	Source
004395	NDDF
109116008	SNOMEDCT_US
109117004	SNOMEDCT_US
134413	RXNORM
140207-93-8	SECONDARY_CAS_RN
372571007	SNOMEDCT_US
4021013	VANDF
5255	MMSL
5909	MMSL
6311	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ELMIRON	HUMAN PRESCRIPTION DRUG LABEL	1	50458-098	CAPSULE, GELATIN COATED	100 mg	ORAL	NDA	25 sections
ELMIRON	HUMAN PRESCRIPTION DRUG LABEL	1	50458-098	CAPSULE, GELATIN COATED	100 mg	ORAL	NDA	25 sections
Elmiron	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4525	CAPSULE, GELATIN COATED	100 mg	ORAL	NDA	25 sections

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