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Toradol, Omidria(ketorolac)
Acular, Acuvail, Omidria, Sprix (ketorolac) is a small molecule pharmaceutical. Ketorolac was first approved as Toradol on 1989-11-30. It is used to treat pain in the USA. It has been approved in Europe to treat intraocular lens implantation and postoperative pain. The pharmaceutical is active against prostaglandin G/H synthase 1 and prostaglandin G/H synthase 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
operative surgical proceduresD013514
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Acular, Acuvail, Sprix (generic drugs available since 1997-05-16, discontinued: Toradol)
Combinations
Omidria (generic drugs available since 1997-05-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ketorolac tromethamine
Tradename
Company
Number
Date
Products
ACULARAbbVieN-019700 RX1992-11-09
1 products, RLD, RS
ACULAR LSAbbVieN-021528 RX2003-05-30
1 products, RLD, RS
ACUVAILAbbVieN-022427 RX2009-07-22
1 products, RLD, RS
SPRIXZyla Life SciencesN-022382 RX2010-05-14
1 products, RLD, RS
Show 3 discontinued
Ketorolac tromethamine
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
OMIDRIARayner SurgicalN-205388 RX2014-05-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
acularNew Drug Application2012-06-01
acuvailNew Drug Application2019-02-21
ketorolac tromethamineANDA2023-06-19
omidria New Drug Application2017-12-11
sprixNew Drug Application2020-03-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ketorolac Tromethamine / Phenylephrine Hydrochloride, Omidria, Rayner Surgical
90668562033-10-23DP
94864062033-10-23DP
98552462033-10-23DP
81737072023-07-30U-1518
85866332023-07-30DP
92781012023-07-30U-1518
93990402023-07-30DP
Ketorolac Tromethamine, Acuvail, Abbvie
78427142029-08-15DS, DP
85127172028-03-07DP
91925712028-03-07DP
89929522024-08-05DP
Ketorolac Tromethamine, Acular Ls, Abbvie
80083382027-05-24DS, DPU-1181
82072152024-05-28U-1251
83779822024-05-28U-1363
85414632024-05-28U-1441
86481072024-05-28DP
89069502024-05-28U-1626
89462812024-05-28U-1662
92161672024-05-28U-1800
ATC Codes
M: Musculo-skeletal system drugs
M01: Antiinflammatory and antirheumatic products
M01A: Antiinflammatory and antirheumatic products, non-steroids
M01AB: Acetic acid derivatives and related substances
M01AB15: Ketorolac
S: Sensory organ drugs
S01: Ophthalmologicals
S01B: Antiinflammatory agents, ophthalmologic
S01BC: Antiinflammatory agents, non-steroidal, ophthalmologic
S01BC05: Ketorolac
S01F: Mydriatics and cycloplegics
S01FB: Sympathomimetics excl. antiglaucoma preparations
S01FB51: Phenylephrine and ketorolac
HCPCS
Code
Description
J1097
Phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml
J1885
Injection, ketorolac tromethamine, per 15 mg
Clinical
Clinical Trials
373 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149G89.186101518957
PainD010146EFO_0003843R5226617535
CataractD002386EFO_0001059H26.91312319
Macular edemaD008269314412
Migraine disordersD008881EFO_0003821G431235111
Replacement arthroplasty kneeD01964536110
Knee osteoarthritisD020370EFO_0004616M171629
Acute painD059787R5223318
Renal colicD056844EFO_1001412N23112328
OsteoarthritisD010003EFO_0002506M15-M192417
Show 83 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AppendicitisD001064EFO_0007149K37213
Abdominal painD015746R10.933
Breast neoplasmsD001943EFO_0003869C50133
Anterior cruciate ligament injuriesD000070598122
Chronic painD059350HP_0012532112
Deglutition disordersD003680HP_0002015R13.111
DysphoniaD055154R49.011
Local anesthesiaD00077211
Spinal fusionD01312311
Tennis elbowD013716EFO_1001896M77.111
Show 21 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients819
PulpitisD011671EFO_1001139K04.0437
PhimosisD010688EFO_1001104N47.1112
ParaphimosisD010263EFO_1001086N47.2112
BalanitisD001446EFO_1000833N48.1112
Diabetic retinopathyD003930EFO_0003770112
Shoulder impingement syndromeD019534EFO_1001178M75.4112
ScoliosisD012600EFO_0004273M4111
MiosisD015877HP_0000616H57.0311
Pre-eclampsiaD011225EFO_0000668O1411
Show 9 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal cell carcinomaD002292112
Ovarian neoplasmsD010051EFO_0003893C56112
Fallopian tube neoplasmsD005185112
Cluster headacheD003027HP_0012199G44.0011
Trigeminal neuralgiaD014277EFO_1001219G50.011
Cerebral arterial diseasesD002539EFO_100085911
Urologic diseasesD014570N39.911
Allergic rhinitisD065631J30.911
Non-small-cell lung carcinomaD00228911
MammaplastyD01646211
Show 8 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BunionD000071378M21.6122
Pathologic dilatationD00410822
KeratoconusD007640EFO_0004223H18.622
RegenerationD01203822
Open-angle glaucomaD005902EFO_0004190H40.122
Retinal vein occlusionD012170EFO_1001157H34.8111
Macular degenerationD008268EFO_0001365H35.3011
Head and neck neoplasmsD00625811
Laparoscopic cholecystectomyD01708111
Inguinal herniaD006552HP_0000023K4011
Show 19 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameKETOROLAC
INNketorolac
Description
Ketorolac is a racemate comprising equimolar amounts of (R)-(+)- and (S)-(-)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid. While only the (S)-(-) enantiomer is a COX1 and COX2 inhibitor, the (R)-(+) enantiomer exhibits potent analgesic activity. A non-steroidal anti-inflammatory drug, ketorolac is mainly used (generally as the tromethamine salt) for its potent analgesic properties in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. It was withdrawn from the market in many countries in 1993 following association with haemorrhage and renal failure. It has a role as a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, a non-steroidal anti-inflammatory drug and an analgesic. It contains a (R)-ketorolac and a (S)-ketorolac. It is a conjugate acid of a ketorolac(1-).
Classification
Small molecule
Drug classanti-inflammatory agents (acetic acid derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Identifiers
PDB4GRK
CAS-ID74103-06-3
RxCUI35827
ChEMBL IDCHEMBL469
ChEBI ID76223
PubChem CID3826
DrugBankDB00465
UNII IDYZI5105V0L (ChemIDplus, GSRS)
Target
Agency Approved
PTGS1
PTGS1
PTGS2
PTGS2
Organism
Homo sapiens
Gene name
PTGS1
Gene synonyms
COX1
NCBI Gene ID
Protein name
prostaglandin G/H synthase 1
Protein synonyms
COX-1, Cyclooxygenase-1, PGH synthase 1, PGHS-1, PHS 1, Prostaglandin H2 synthase 1, Prostaglandin-endoperoxide synthase 1, prostaglandin-endoperoxide synthase 1 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs1 (19224)
prostaglandin G/H synthase 1 (P22437)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Sprix - Assertio Therapeutics
$
£
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Sprix - Zyla Life Sciences
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,424 documents
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Safety
Black-box Warning
Black-box warning for: Ketorolac tromethamine, Sprix
Adverse Events
Top Adverse Reactions
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4,533 adverse events reported
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