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

Stem definition	Drug id	CAS RN
	1331	126-07-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: griseofulvin griseofulvin, microcrystalline (+)-Griseofulvin grisefulin griseofulvin, ultramicrocrystalline griseofulvin, ultramicrosize griseofulvin, microsize	An antifungal agent used in the treatment of TINEA infections. Molecular weight: 352.77 Formula: C17H17ClO6 CLOGP: 2.05 LIPINSKI: 0 HAC: 6 HDO: 0 TPSA: 71.06 ALOGS: -3.84 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

griseofulvin
griseofulvin, microcrystalline
(+)-Griseofulvin
grisefulin
griseofulvin, ultramicrocrystalline
griseofulvin, ultramicrosize
griseofulvin, microsize

An antifungal agent used in the treatment of TINEA infections.

Molecular weight: 352.77
Formula: C17H17ClO6
CLOGP: 2.05
LIPINSKI: 0
HAC: 6
HDO: 0
TPSA: 71.06
ALOGS: -3.84
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.50	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.30 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	35.43 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	47.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Aug. 22, 1962	FDA	WYETH AYERST

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D01AA08	DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE ANTIFUNGALS FOR TOPICAL USE Antibiotics
ATC	D01BA01	DERMATOLOGICALS ANTIFUNGALS FOR DERMATOLOGICAL USE ANTIFUNGALS FOR SYSTEMIC USE Antifungals for systemic use
FDA PE	N0000008732	Decreased Mitosis
FDA PE	N0000175085	Microtubule Inhibition
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000935	Antifungal Agents
FDA EPC	N0000175848	Tubulin Inhibiting Agent
CHEBI has role	CHEBI:33282	bactericides
CHEBI has role	CHEBI:76964	Penicillium metabolites

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

Disease	Relation	SNOMED_ID	DOID
Tinea capitis	indication	5441008
Tinea pedis	indication	6020002	DOID:12403
Tinea corporis	indication	84849002
Tinea cruris	indication	399029005
Tinea barbae	indication	399329002
Onychomycosis due to dermatophyte	indication	402134005
Alcoholism	contraindication	7200002
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Hepatic failure	contraindication	59927004
Liver function tests abnormal	contraindication	166603001
Lupus erythematosus and erythema multiforme-like syndrome	contraindication	238926009
Pregnancy, function	contraindication	289908002
Granulocytopenic disorder	contraindication	417672002
Porphyria	contraindication	418470004

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Fungal infections of the skin, hair, and claws caused by Trichophyton mentagrophytes	Indication
Cats	Fungal infections of the skin, hair, and claws caused by T rubrum	Indication
Cats	Fungal infections of the skin, hair, and claws caused by T schoenleini	Indication
Cats	Fungal infections of the skin, hair, and claws caused by T sulphurem	Indication
Cats	Fungal infections of the skin, hair, and claws caused by T verrucosum	Indication
Cats	Fungal infections of the skin, hair, and claws caused by T interdigitale	Indication
Cats	Fungal infections of the skin, hair, and claws caused by Epidermophyton floccosum	Indication
Cats	Fungal infections of the skin, hair, and claws caused by Microsporum gypseum	Indication
Cats	Fungal infections of the skin, hair, and claws caused by M canis	Indication
Cats	Fungal infections of the skin, hair, and claws caused by M audouini	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by Trichophyton mentagrophytes	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by T rubrum	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by T schoenleini	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by T sulphurem	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by T verrucosum	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by T interdigitale	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by Epidermophyton floccosum	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by Microsporum gypseum	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by M canis	Indication
Dogs	Fungal infections of the skin, hair, and claws caused by M audouini	Indication
Horses	Ringworm infection caused by Trichophyton equinum	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Fulvicin U/F Tablets	Intervet Inc.	1
Grysio (Microsize)	Zoetis Inc.	1
Fulvicin U/F Bolus Veterinary	Intervet Inc.	1
Fulvicin U/F Powder	Intervet Inc.	1
Griseofulvin Powder	Bimeda Animal Health Limited	1

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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Lanosterol 14-alpha demethylase	Enzyme	Q16850	CP51A_HUMAN		IC50	4.30	CHEMBL
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	5.14	CHEMBL
Tubulin	Structural		F2SG63_TRIRC F2SZ02_TRIRC F2SZD3_TRIRC	INHIBITOR			CHEMBL	CHEMBL
Tubulin beta chain	Structural		TBB_CANAX				WOMBAT-PK

External reference:

ID	Source
4018217	VUID
N0000146549	NUI
D00209	KEGG_DRUG
4018215	VANDF
4018216	VANDF
4018217	VANDF
4018218	VANDF
C0018242	UMLSCUI
CHEBI:27779	CHEBI
CHEMBL562	ChEMBL_ID
DB00400	DRUGBANK_ID
D006118	MESH_DESCRIPTOR_UI
441140	PUBCHEM_CID
875	INN_ID
32HRV3E3D5	UNII
217398	RXNORM
12073	MMSL
4296	MMSL
4796	MMSL
4803	MMSL
4804	MMSL
d00100	MMSL
002884	NDDF
002885	NDDF
002886	NDDF
372807004	SNOMEDCT_US
5647000	SNOMEDCT_US
64349004	SNOMEDCT_US
85035000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1724	TABLET, COATED	125 mg	ORAL	ANDA	11 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1724	TABLET, COATED	125 mg	ORAL	ANDA	11 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1725	TABLET, COATED	250 mg	ORAL	ANDA	11 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1725	TABLET, COATED	250 mg	ORAL	ANDA	11 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0013	SUSPENSION	125 mg	ORAL	ANDA	11 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0850	SUSPENSION	125 mg	ORAL	ANDA	19 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5514	TABLET	250 mg	ORAL	ANDA	21 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5515	TABLET	500 mg	ORAL	ANDA	21 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5827	TABLET, COATED	125 mg	ORAL	ANDA	13 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5828	TABLET, COATED	250 mg	ORAL	ANDA	13 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	23155-864	TABLET	125 mg	ORAL	ANDA	13 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	23155-865	TABLET	250 mg	ORAL	ANDA	13 sections
Griseofulviin (microsize)	HUMAN PRESCRIPTION DRUG LABEL	1	42254-306	SUSPENSION	125 mg	ORAL	ANDA	11 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	42794-012	TABLET	500 mg	ORAL	ANDA	11 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	42794-012	TABLET	500 mg	ORAL	ANDA	11 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	42794-013	TABLET	125 mg	ORAL	ANDA	10 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	42794-014	TABLET	250 mg	ORAL	ANDA	10 sections
Gris-PEG	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0261	TABLET, FILM COATED	250 mg	ORAL	NDA	13 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5234	SUSPENSION	125 mg	ORAL	ANDA	12 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	62135-494	TABLET	125 mg	ORAL	ANDA	13 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	62135-494	TABLET	125 mg	ORAL	ANDA	13 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	62135-495	TABLET	250 mg	ORAL	ANDA	13 sections
Ultramicrosize Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	62135-495	TABLET	250 mg	ORAL	ANDA	13 sections
Griseofulvin MICROSIZE	HUMAN PRESCRIPTION DRUG LABEL	1	62135-496	TABLET	500 mg	ORAL	ANDA	19 sections
Griseofulvin MICROSIZE	HUMAN PRESCRIPTION DRUG LABEL	1	62135-496	TABLET	500 mg	ORAL	ANDA	19 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	62135-968	SUSPENSION	125 mg	ORAL	ANDA	11 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	62135-968	SUSPENSION	125 mg	ORAL	ANDA	11 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	64980-184	TABLET	125 mg	ORAL	ANDA	10 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	64980-185	TABLET	250 mg	ORAL	ANDA	10 sections
Griseofulvin	HUMAN PRESCRIPTION DRUG LABEL	1	64980-186	TABLET	500 mg	ORAL	ANDA	11 sections