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

Stem definition	Drug id	CAS RN
phenylazosalicylic acid derivatives antibacterial	1988	6054-98-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: olsalazine olsalazine sodium CJ 91B dipentum azodisalicylate	cpd with 2 salicylate molecules linked together by an azo bond Molecular weight: 302.24 Formula: C14H10N2O6 CLOGP: 4.57 LIPINSKI: 0 HAC: 8 HDO: 4 TPSA: 139.78 ALOGS: -3.59 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

olsalazine
olsalazine sodium
CJ 91B
dipentum
azodisalicylate

cpd with 2 salicylate molecules linked together by an azo bond

Molecular weight: 302.24
Formula: C14H10N2O6
CLOGP: 4.57
LIPINSKI: 0
HAC: 8
HDO: 4
TPSA: 139.78
ALOGS: -3.59
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	g	O

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	55.25 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	41 mg/mL	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	2 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	1.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
t_half (Half-life)	0.90 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.07 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
July 31, 1990	FDA	MEDA PHARMS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

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
Colitis ulcerative	66.63	56.50	13	59	34729	79709587

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A07EC03	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Aminosalicylic acid and similar agents
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:50266	Prodrugs
FDA CS	M0000971	Aminosalicylic Acids
FDA EPC	N0000175781	Aminosalicylate
MeSH PA	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D000894	Anti-Inflammatory Agents, Non-Steroidal
MeSH PA	D018501	Antirheumatic 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
Ulcerative colitis in remission	indication	697969008
Crohn's disease	off-label use	34000006
Ulcerative colitis	off-label use	64766004	DOID:8577
Allergic rhinitis	contraindication	61582004
Diarrhea	contraindication	62315008
Kidney disease	contraindication	90708001	DOID:557
Asthma	contraindication	195967001	DOID:2841
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

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	1.98	acidic
pKa2	2.58	acidic
pKa3	11.15	acidic
pKa4	11.76	acidic

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Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Arachidonate 5-lipoxygenase	Enzyme	P09917	LOX5_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN	AGONIST			CHEMBL	CHEMBL
Cyclooxygenase	Enzyme	P23219 P35354	PGH1_HUMAN PGH2_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Flavin reductase (NADPH)	Enzyme	P30043	BLVRB_HUMAN		Kd	7.16	CHEMBL

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External reference:

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ID	Source
001600	NDDF
003554	NDDF
004656	NDDF
104123	RXNORM
108673002	SNOMEDCT_US
108674008	SNOMEDCT_US
11578	IUPHAR_LIGAND_ID
15722-48-2	SECONDARY_CAS_RN
22419	PUBCHEM_CID
37855	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dipentum	HUMAN PRESCRIPTION DRUG LABEL	1	0037-6860	CAPSULE, GELATIN COATED	250 mg	ORAL	NDA	25 sections
Dipentum	HUMAN PRESCRIPTION DRUG LABEL	1	0037-6860	CAPSULE, GELATIN COATED	250 mg	ORAL	NDA	25 sections
Dipentum	HUMAN PRESCRIPTION DRUG LABEL	1	0037-6860	CAPSULE, GELATIN COATED	250 mg	ORAL	NDA	25 sections
Dipentum	HUMAN PRESCRIPTION DRUG LABEL	1	0037-6860	CAPSULE, GELATIN COATED	250 mg	ORAL	NDA	25 sections
Dipentum	HUMAN PRESCRIPTION DRUG LABEL	1	68151-0312	CAPSULE, GELATIN COATED	250 mg	ORAL	NDA	25 sections
Dipentum	HUMAN PRESCRIPTION DRUG LABEL	1	68151-3120	CAPSULE, GELATIN COATED	250 mg	ORAL	NDA	27 sections

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