Stem definition | Drug id | CAS RN |
---|---|---|
anti-inflammatory agents, ibufenac derivatives | 401 | 91714-94-2 |
None
Property | Value | Reference |
---|---|---|
MRTD (Maximum Recommended Therapeutic Daily Dose) | 4.28 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Hosey CM, Chan R, Benet LZ |
BA (Bioavailability) | 67 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Vd (Volume of distribution) | 0.11 L/kg | Lombardo F, Berellini G, Obach RS |
CL (Clearance) | 1.30 mL/min/kg | Lombardo F, Berellini G, Obach RS |
fu (Fraction unbound in plasma) | 0.00 % | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 2.60 hours | Lombardo F, Berellini G, Obach RS |
Date | Agency | Company | Orphan |
---|---|---|---|
March 24, 2005 | FDA | BAUSCH AND LOMB INC |
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 |
---|---|---|---|---|---|---|
Corneal oedema | 113.14 | 37.29 | 20 | 929 | 1367 | 50602808 |
Endophthalmitis | 92.41 | 37.29 | 19 | 930 | 2897 | 50601278 |
Hypopyon | 84.36 | 37.29 | 14 | 935 | 655 | 50603520 |
Cataract | 73.44 | 37.29 | 29 | 920 | 47271 | 50556904 |
Toxic anterior segment syndrome | 72.48 | 37.29 | 14 | 935 | 1551 | 50602624 |
Eye irritation | 71.54 | 37.29 | 22 | 927 | 17118 | 50587057 |
Eye pain | 64.37 | 37.29 | 23 | 926 | 28426 | 50575749 |
Product packaging quantity issue | 58.36 | 37.29 | 11 | 938 | 1069 | 50603106 |
Corneal infiltrates | 49.10 | 37.29 | 7 | 942 | 117 | 50604058 |
Corneal disorder | 48.01 | 37.29 | 10 | 939 | 1616 | 50602559 |
Visual impairment | 44.96 | 37.29 | 23 | 926 | 68252 | 50535923 |
Ocular hyperaemia | 40.61 | 37.29 | 15 | 934 | 20277 | 50583898 |
Corneal perforation | 39.60 | 37.29 | 7 | 942 | 475 | 50603700 |
Anterior chamber cell | 39.43 | 37.29 | 7 | 942 | 487 | 50603688 |
Corneal opacity | 37.47 | 37.29 | 7 | 942 | 647 | 50603528 |
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 |
---|---|---|---|---|---|---|
Cataract | 82.44 | 48.59 | 25 | 443 | 22353 | 29551706 |
Ulcerative keratitis | 51.09 | 48.59 | 10 | 458 | 1413 | 29572646 |
Hypopyon | 50.46 | 48.59 | 8 | 460 | 334 | 29573725 |
Endophthalmitis | 49.65 | 48.59 | 11 | 457 | 2837 | 29571222 |
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 |
---|---|---|---|---|---|---|
Corneal oedema | 149.95 | 38.04 | 27 | 1047 | 2316 | 64495342 |
Endophthalmitis | 145.01 | 38.04 | 30 | 1044 | 5335 | 64492323 |
Hypopyon | 128.56 | 38.04 | 21 | 1053 | 1008 | 64496650 |
Toxic anterior segment syndrome | 116.75 | 38.04 | 22 | 1052 | 2417 | 64495241 |
Eye pain | 88.16 | 38.04 | 29 | 1045 | 31596 | 64466062 |
Cataract | 78.04 | 38.04 | 30 | 1044 | 51232 | 64446426 |
Corneal disorder | 70.51 | 38.04 | 14 | 1060 | 2013 | 64495645 |
Corneal opacity | 68.24 | 38.04 | 12 | 1062 | 893 | 64496765 |
Ocular hyperaemia | 68.13 | 38.04 | 22 | 1052 | 22542 | 64475116 |
Corneal infiltrates | 66.58 | 38.04 | 10 | 1064 | 275 | 64497383 |
Ulcerative keratitis | 64.60 | 38.04 | 14 | 1060 | 3083 | 64494575 |
Anterior chamber cell | 62.62 | 38.04 | 11 | 1063 | 813 | 64496845 |
Visual acuity reduced | 52.65 | 38.04 | 19 | 1055 | 27122 | 64470536 |
Corneal perforation | 51.10 | 38.04 | 9 | 1065 | 675 | 64496983 |
Eye irritation | 50.05 | 38.04 | 16 | 1058 | 15840 | 64481818 |
Lacrimation increased | 43.82 | 38.04 | 15 | 1059 | 18331 | 64479327 |
Visual impairment | 42.82 | 38.04 | 22 | 1052 | 74055 | 64423603 |
Punctate keratitis | 42.60 | 38.04 | 8 | 1066 | 857 | 64496801 |
Intraocular pressure increased | 41.77 | 38.04 | 12 | 1062 | 8290 | 64489368 |
Vision blurred | 41.45 | 38.04 | 23 | 1051 | 90293 | 64407365 |
Metamorphopsia | 40.45 | 38.04 | 8 | 1066 | 1124 | 64496534 |
Eye inflammation | 38.30 | 38.04 | 10 | 1064 | 4847 | 64492811 |
None
Source | Code | Description |
---|---|---|
ATC | S01BC11 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Antiinflammatory agents, non-steroids |
FDA CS | M0001335 | Anti-Inflammatory Agents, Non-Steroidal |
FDA MoA | N0000000160 | Cyclooxygenase Inhibitors |
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 |
MeSH PA | D018373 | Peripheral Nervous System Agents |
MeSH PA | D018689 | Sensory System Agents |
FDA EPC | N0000175722 | Nonsteroidal Anti-inflammatory Drug |
CHEBI has role | CHEBI:35475 | non-steroidal anti-inflammatory agent |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Pain | indication | 22253000 | |
Postoperative Ocular Pain | indication | ||
Post-Op Ocular Inflammation | indication | ||
Rheumatoid arthritis | contraindication | 69896004 | DOID:7148 |
Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
Red eye | contraindication | 75705005 | |
Epithelial Keratopathy | contraindication |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 4.32 | acidic |
pKa2 | 3.17 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 0.07% ACID | PROLENSA | BAUSCH AND LOMB | N203168 | April 5, 2013 | RX | SOLUTION/DROPS | OPHTHALMIC | 8927606 | Jan. 16, 2024 | METHOD OF TREATING OCULAR INFLAMMATION |
EQ 0.07% ACID | PROLENSA | BAUSCH AND LOMB | N203168 | April 5, 2013 | RX | SOLUTION/DROPS | OPHTHALMIC | 8927606 | Jan. 16, 2024 | METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE |
EQ 0.07% ACID | PROLENSA | BAUSCH AND LOMB | N203168 | April 5, 2013 | RX | SOLUTION/DROPS | OPHTHALMIC | 9561277 | Jan. 16, 2024 | TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY |
EQ 0.075% ACID | BROMSITE | SUN PHARM | N206911 | April 8, 2016 | RX | SOLUTION/DROPS | OPHTHALMIC | 8778999 | Aug. 7, 2029 | TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY |
EQ 0.07% ACID | PROLENSA | BAUSCH AND LOMB | N203168 | April 5, 2013 | RX | SOLUTION/DROPS | OPHTHALMIC | 9517220 | Nov. 11, 2033 | TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY |
None
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Prostaglandin G/H synthase 2 | Enzyme | INHIBITOR | IC50 | 8.40 | WOMBAT-PK | CHEMBL | |||
Prostaglandin G/H synthase 1 | Enzyme | INHIBITOR | IC50 | 8.29 | WOMBAT-PK | CHEMBL | |||
Cyclooxygenase | Enzyme | IC50 | 7.10 | CHEMBL |
ID | Source |
---|---|
D07541 | KEGG_DRUG |
120638-55-3 | SECONDARY_CAS_RN |
1375918 | RXNORM |
C0054094 | UMLSCUI |
CHEBI:240107 | CHEBI |
27R | PDB_CHEM_ID |
CHEMBL1077 | ChEMBL_ID |
CHEMBL751 | ChEMBL_ID |
DB00963 | DRUGBANK_ID |
C053083 | MESH_SUPPLEMENTAL_RECORD_UI |
60726 | PUBCHEM_CID |
7131 | IUPHAR_LIGAND_ID |
5892 | INN_ID |
864P0921DW | UNII |
181436 | MMSL |
200626 | MMSL |
31652 | MMSL |
34500 | MMSL |
35934 | MMSL |
4299 | MMSL |
67379 | MMSL |
d04150 | MMSL |
006757 | NDDF |
006758 | NDDF |
108520008 | SNOMEDCT_US |
108521007 | SNOMEDCT_US |
417155005 | SNOMEDCT_US |
725788000 | SNOMEDCT_US |
4021048 | VANDF |
4024075 | VANDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Prolensa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-602 | SOLUTION/ DROPS | 0.70 mg | OPHTHALMIC | NDA | 22 sections |
Prolensa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-602 | SOLUTION/ DROPS | 0.70 mg | OPHTHALMIC | NDA | 22 sections |
BROMSITE0.075% | Human Prescription Drug Label | 1 | 49708-754 | SOLUTION/ DROPS | 0.76 mg | OPHTHALMIC | NDA | 23 sections |
bromfenac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50383-249 | SOLUTION/ DROPS | 1.04 mg | OPHTHALMIC | ANDA | 25 sections |
bromfenac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50383-249 | SOLUTION/ DROPS | 1.04 mg | OPHTHALMIC | ANDA | 25 sections |
Bromday | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50436-6301 | SOLUTION/ DROPS | 0.90 mg | OPHTHALMIC | NDA | 22 sections |
Bromday | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6301 | SOLUTION/ DROPS | 0.90 mg | OPHTHALMIC | NDA | 22 sections |
Bromfenac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6343 | SOLUTION/ DROPS | 1.04 mg | OPHTHALMIC | ANDA | 23 sections |
Bromfenac Ophthalmic Solution 0.09% | Human Prescription Drug Label | 1 | 62332-508 | SOLUTION/ DROPS | 1.04 mg | OPHTHALMIC | ANDA | 22 sections |
Bromfenac | Human Prescription Drug Label | 1 | 65862-789 | SOLUTION/ DROPS | 0.90 mg | OPHTHALMIC | ANDA | 22 sections |
BROMFENAC | Human Prescription Drug Label | 1 | 68083-313 | SOLUTION/ DROPS | 0.90 mg | OPHTHALMIC | ANDA | 22 sections |
Pred-Gati-Brom | HUMAN PRESCRIPTION DRUG LABEL | 3 | 70261-504 | SUSPENSION/ DROPS | 0.75 mg | OPHTHALMIC | unapproved drug other | 2 sections |
Pred-Brom | HUMAN PRESCRIPTION DRUG LABEL | 2 | 70261-505 | SUSPENSION/ DROPS | 0.75 mg | OPHTHALMIC | unapproved drug other | 2 sections |
Pred-Brom | HUMAN PRESCRIPTION DRUG LABEL | 2 | 71384-505 | SUSPENSION/ DROPS | 0.75 mg | OPHTHALMIC | unapproved drug other | 2 sections |
Pred Phos - Brom | HUMAN PRESCRIPTION DRUG LABEL | 2 | 71384-552 | SOLUTION/ DROPS | 0.75 mg | OPHTHALMIC | unapproved drug other | 2 sections |
BROMFENAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72266-142 | SOLUTION/ DROPS | 0.90 mg | OPHTHALMIC | ANDA | 22 sections |