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 | 113.67 | 39.28 | 20 | 982 | 1402 | 56289663 |
Endophthalmitis | 91.97 | 39.28 | 19 | 983 | 3124 | 56287941 |
Hypopyon | 84.27 | 39.28 | 14 | 988 | 695 | 56290370 |
Eye pain | 79.08 | 39.28 | 27 | 975 | 30820 | 56260245 |
Toxic anterior segment syndrome | 78.39 | 39.28 | 15 | 987 | 1667 | 56289398 |
Cataract | 76.13 | 39.28 | 30 | 972 | 51217 | 56239848 |
Eye irritation | 74.61 | 39.28 | 23 | 979 | 19005 | 56272060 |
Product packaging quantity issue | 57.64 | 39.28 | 11 | 991 | 1203 | 56289862 |
Corneal opacity | 50.35 | 39.28 | 9 | 993 | 687 | 56290378 |
Corneal infiltrates | 48.18 | 39.28 | 7 | 995 | 142 | 56290923 |
Corneal disorder | 47.73 | 39.28 | 10 | 992 | 1752 | 56289313 |
Visual impairment | 44.27 | 39.28 | 23 | 979 | 74179 | 56216886 |
Ocular hyperaemia | 43.89 | 39.28 | 16 | 986 | 21963 | 56269102 |
Anterior chamber cell | 39.42 | 39.28 | 7 | 995 | 514 | 56290551 |
Corneal perforation | 39.30 | 39.28 | 7 | 995 | 523 | 56290542 |
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 | 91.80 | 45.84 | 28 | 510 | 23779 | 31673027 |
Hypopyon | 63.88 | 45.84 | 10 | 528 | 358 | 31696448 |
Toxic anterior segment syndrome | 59.05 | 45.84 | 11 | 527 | 1114 | 31695692 |
Eye pain | 58.26 | 45.84 | 17 | 521 | 12287 | 31684519 |
Corneal oedema | 51.74 | 45.84 | 10 | 528 | 1231 | 31695575 |
Endophthalmitis | 51.50 | 45.84 | 12 | 526 | 3604 | 31693202 |
Ulcerative keratitis | 49.23 | 45.84 | 10 | 528 | 1586 | 31695220 |
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 | 155.62 | 37.72 | 28 | 1133 | 2432 | 70924851 |
Endophthalmitis | 146.62 | 37.72 | 31 | 1130 | 6224 | 70921059 |
Hypopyon | 141.86 | 37.72 | 23 | 1138 | 1072 | 70926211 |
Toxic anterior segment syndrome | 134.42 | 37.72 | 25 | 1136 | 2605 | 70924678 |
Eye pain | 115.10 | 37.72 | 36 | 1125 | 34066 | 70893217 |
Cataract | 86.83 | 37.72 | 33 | 1128 | 55612 | 70871671 |
Corneal opacity | 80.82 | 37.72 | 14 | 1147 | 972 | 70926311 |
Corneal disorder | 69.74 | 37.72 | 14 | 1147 | 2165 | 70925118 |
Ulcerative keratitis | 69.43 | 37.72 | 15 | 1146 | 3312 | 70923971 |
Ocular hyperaemia | 66.59 | 37.72 | 22 | 1139 | 24617 | 70902666 |
Corneal infiltrates | 65.75 | 37.72 | 10 | 1151 | 305 | 70926978 |
Anterior chamber cell | 61.78 | 37.72 | 11 | 1150 | 894 | 70926389 |
Eye irritation | 52.55 | 37.72 | 17 | 1144 | 17771 | 70909512 |
Visual acuity reduced | 52.42 | 37.72 | 19 | 1142 | 27911 | 70899372 |
Lacrimation increased | 50.68 | 37.72 | 17 | 1144 | 19882 | 70907401 |
Corneal perforation | 50.67 | 37.72 | 9 | 1152 | 721 | 70926562 |
Visual impairment | 47.26 | 37.72 | 24 | 1137 | 80226 | 70847057 |
Vision blurred | 43.46 | 37.72 | 24 | 1137 | 94960 | 70832323 |
Punctate keratitis | 42.24 | 37.72 | 8 | 1153 | 912 | 70926371 |
Cystoid macular oedema | 41.83 | 37.72 | 9 | 1152 | 1943 | 70925340 |
Intraocular pressure increased | 41.14 | 37.72 | 12 | 1149 | 8889 | 70918394 |
Metamorphopsia | 40.37 | 37.72 | 8 | 1153 | 1155 | 70926128 |
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 |
4021048 | VANDF |
4024075 | VANDF |
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 |
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 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 |