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griseofulvin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1331 | 126-07-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An antifungal agent used in the treatment of TINEA infections.
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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.871 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 2.065 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 53.827 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 4.508 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 12.280 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 21.130 | % | High | 1 |
| herg | hERG pIC50 | 4.430 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 3.750 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 28.576 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 11.230 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKCD,PRKDC,SIK2,STK33,SYK,TEK,TTK,ZAP70 | 49 | |||
| kinase-selectivity-class | AXL,BRAF,EIF2AK3,ERBB2,GRK2,PDK4,TEK,TTK | 8 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 0.787 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 4.550 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 27.797 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 8.830 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 21.979 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 19.060 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.215 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 20.137 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 66.870 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 6.570 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 142.561 | uM | High | 1 |
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 | antibacterial agent |
| CHEBI has role | CHEBI:35441 | antiinfective agent |
| CHEBI has role | CHEBI:76964 | <em>Penicillium</em> metabolite |
Related Drugs by ATC class:
D01AA Antibiotics 6 drugs
D01BA Antifungals for systemic use 1 drug
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]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Lanosterol 14-alpha demethylase | Enzyme | IC50 | 4.30 | CHEMBL | |||||
| Solute carrier family 22 member 1 | Transporter | IC50 | 5.14 | CHEMBL | |||||
| Tubulin | Structural | INHIBITOR | CHEMBL | CHEMBL | |||||
| Tubulin beta chain | Structural | 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 |
| 32HRV3E3D5 | INXIGHT DRUGS |
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 | 0115-1725 | 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 | 23155-863 | TABLET | 125 mg | ORAL | ANDA | 13 sections |
| Ultramicrosize Griseofulvin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-863 | TABLET | 125 mg | ORAL | ANDA | 13 sections |
| Ultramicrosize Griseofulvin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-864 | TABLET | 250 mg | ORAL | ANDA | 13 sections |
| Ultramicrosize Griseofulvin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-864 | TABLET | 250 mg | ORAL | ANDA | 13 sections |
| GRISEOFULVIN MICROSIZE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-865 | TABLET | 500 mg | ORAL | ANDA | 16 sections |
| GRISEOFULVIN MICROSIZE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-865 | TABLET | 500 mg | ORAL | ANDA | 16 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 |
| 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 | 11 sections |
| Ultramicrosize Griseofulvin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-495 | TABLET | 250 mg | ORAL | ANDA | 11 sections |
| Griseofulvin MICROSIZE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-496 | TABLET | 500 mg | ORAL | ANDA | 19 sections |
| ULTRAMICROSIZE GRISEOFULVIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-501 | TABLET | 165 mg | ORAL | ANDA | 9 sections |
| Griseofulvin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-968 | SUSPENSION | 125 mg | ORAL | ANDA | 11 sections |
| grisofulvin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-361 | SUSPENSION | 125 mg | ORAL | ANDA | 16 sections |
| ULTRAMICROSIZE GRISEOFULVIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73308-435 | TABLET | 165 mg | ORAL | ANDA | 9 sections |