Nazione: Canada
Lingua: inglese
Fonte: Health Canada
KETOROLAC TROMETHAMINE
NU-PHARM INC
S01BC05
KETOROLAC
0.5%
SOLUTION
KETOROLAC TROMETHAMINE 0.5%
OPHTHALMIC
100
Prescription
NONSTEROIDAL ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0121995003; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2018-03-28
PRODUCT MONOGRAPH NU-KETOROLAC KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% TOPICAL ANTI-INFLAMMATORY AGENT NU-PHARM INC. DATE OF PREPARATION: 50 MURAL STREET, UNITS 1 & 2 OCTOBER 22, 2009 RICHMOND HILL, ONTARIO L4B 1E4 CONTROL#: 133486 - 2 - PRODUCT MONOGRAPH NU-KETOROLAC Ketorolac Tromethamine Ophthalmic Solution 0.5% PHARMACOLOGIC/THERAPEUTIC CLASSIFICATION Topical Anti-Inflammatory Agent ACTIONS AND CLINICAL PHARMACOLOGY Ketorolac tromethamine is a non-steroidal, anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. At concentrations of 0.02% to 0.5%, ketorolac tromethamine solution did not irritate the eyes of rats, dogs and monkeys. Up to 4.0% concentrations were nonirritating in albino rabbits. Ketorolac tromethamine has demonstrated anti-inflammatory activity when applied topically in several animal models of ocular inflammation. The compound significantly inhibited the inflammatory responses to silver nitrate-induced cauterization of the corneas of rat eyes at concentrations of 0.25% and 0.5%. Concentrations of ketorolac ranging from 0.02% to 0.5% blocked vascular permeability changes caused by endotoxin-induced uveitis in the eyes of rabbits. Using the same model, ketorolac also blocked endotoxin-induced elevation of aqueous humor PGE2. It prevented the development of increased intraocular pressure induced in rabbits with topically applied arachidonic acid. Ketorolac did not inhibit rabbit lens aldose reductase _in _ _vitro. _ Applications of a 0.5% ketorolac solution did not delay the healing of experimental corneal wounds in rabbits. This solution did not enhance the spread of experimental ocular infections induced in rabbits with _Candida albicans, Herpes simplex_ virus type one, or _Pseudomonas _ _aeruginosa_. - 3 - Two drops (0.1 mL) of 0.5% ketorolac tromethamine ophthalmic solution, instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction, achieved measurable levels in 8 of 9 patients' eyes. The mean ketorolac concentration was 95 ng/mL in Leggi il documento completo