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flunisolide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1201 | 3385-03-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
corticosteroid prescribed as treatment for allergic rhinitis
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.15 | mg | N |
| 1 | mg | Inhal.aerosol |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.07 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 8 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 1.08 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 9.50 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.24 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 1.68 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.007 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 3.342 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 43.954 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 8.610 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 29.330 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 37.280 | % | High | 1 |
| herg | hERG pIC50 | 4.367 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 6.026 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 19.679 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 24.530 | % | High | 1 |
| kinase-safety-class | ACVR2B,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,MAPK10,NTRK2,PDK1,PDK2,PDK4,PRKDC | 12 | |||
| kinase-selectivity-class | GRK2,MAP2K6 | 2 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 7.362 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 27.353 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 28.470 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 16.558 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 37.550 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 34.754 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 74.870 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 19.170 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 613.762 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 24, 1981 | FDA |
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 |
|---|---|---|---|---|---|---|
| Nasal discomfort | 61.08 | 28.43 | 12 | 439 | 5536 | 90622460 |
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 |
|---|---|---|---|---|---|---|
| Nasal discomfort | 56.70 | 24.19 | 13 | 1645 | 1569 | 42618108 |
| International normalised ratio increased | 29.33 | 24.19 | 20 | 1638 | 48148 | 42571529 |
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 |
|---|---|---|---|---|---|---|
| Nasal discomfort | 104.26 | 23.31 | 23 | 1622 | 6158 | 110581496 |
| Dehydration | 33.65 | 23.31 | 30 | 1615 | 279481 | 110308173 |
| International normalised ratio increased | 25.64 | 23.31 | 16 | 1629 | 86756 | 110500898 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R01AD04 | RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids |
| ATC | R03BA03 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D018927 | Anti-Asthmatic Agents |
| MeSH PA | D019141 | Respiratory System Agents |
| CHEBI has role | CHEBI:35472 | anti-inflammatory drug |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:49167 | anti-asthmatic drug |
| CHEBI has role | CHEBI:50857 | anti-allergic agent |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
| CHEBI has role | CHEBI:77715 | nasal decongestant |
Related Drugs by ATC class:
R01AD Corticosteroids 12 drugs
R03BA Glucocorticoids 8 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Allergic rhinitis | indication | 61582004 | |
| Asthma | indication | 195967001 | DOID:2841 |
| Asthma management | indication | 406162001 | |
| Allergic Rhinitis Prevention | indication | ||
| Chronic Non-Allergic Rhinitis | indication | ||
| Severe chronic obstructive pulmonary disease | off-label use | 313299006 | |
| Mycosis | contraindication | 3218000 | DOID:1564 |
| Inactive tuberculosis | contraindication | 11999007 | |
| Epistaxis | contraindication | 12441001 | |
| Measles | contraindication | 14189004 | DOID:8622 |
| Disease caused by parasite | contraindication | 17322007 | |
| Glaucoma | contraindication | 23986001 | DOID:1686 |
| Acute tuberculosis | contraindication | 25629007 | |
| Perforation of nasal septum | contraindication | 80142000 | |
| Bacterial infectious disease | contraindication | 87628006 | |
| Operation on nose | contraindication | 88733004 | |
| Bilateral cataracts | contraindication | 95722004 | |
| Ophthalmic herpes simplex | contraindication | 186542001 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Varicella-zoster virus infection | contraindication | 309465005 | |
| Adrenal cortical hypofunction | contraindication | 386584007 | DOID:10493 |
| Exposure to varicella | contraindication | 444453009 | |
| Oropharyngeal Candidiasis | contraindication | ||
| Nasal Septal Ulcers | contraindication | ||
| Nasal Trauma | contraindication | ||
| Uncontrolled Bacterial Infections | contraindication | ||
| Nasal Candidiasis | contraindication | ||
| Untreated Fungal Infection | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.78 | acidic |
| pKa2 | 12.78 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Glucocorticoid receptor | Nuclear hormone receptor | AGONIST | EC50 | 9.10 | WOMBAT-PK | CHEMBL | |||
| Progesterone receptor | Transcription factor | Ki | 7.33 | DRUG MATRIX |
External reference:
| ID | Source |
|---|---|
| 4018433 | VUID |
| N0000146759 | NUI |
| D00324 | KEGG_DRUG |
| 77326-96-6 | SECONDARY_CAS_RN |
| 4018433 | VANDF |
| C0060501 | UMLSCUI |
| CHEBI:5106 | CHEBI |
| CHEMBL1512 | ChEMBL_ID |
| DB00180 | DRUGBANK_ID |
| C007734 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7076 | IUPHAR_LIGAND_ID |
| QK4DYS664X | UNII |
| 82153 | PUBCHEM_CID |
| 218620 | RXNORM |
| 2119 | MMSL |
| 43033 | MMSL |
| 4737 | MMSL |
| d00761 | MMSL |
| 002195 | NDDF |
| 116588001 | SNOMEDCT_US |
| 43879000 | SNOMEDCT_US |
| QK4DYS664X | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Flunisolide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-344 | SOLUTION | 0.25 mg | NASAL | ANDA | 13 sections |
| Flunisolide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-344 | SOLUTION | 0.25 mg | NASAL | ANDA | 13 sections |
| Flunisolide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-317 | SOLUTION | 0.25 mg | NASAL | ANDA | 20 sections |
| Flunisolide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4799 | SOLUTION | 0.25 mg | NASAL | ANDA | 18 sections |
| Flunisolide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68682-344 | SOLUTION | 0.25 mg | NASAL | ANDA | 12 sections |