מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
KETOROLAC TROMETHAMINE
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
S01BC05
KETOROLAC
0.5%
SOLUTION
KETOROLAC TROMETHAMINE 0.5%
OPHTHALMIC
5/10ML
Prescription
NONSTEROIDAL ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0121995003; AHFS:
CANCELLED POST MARKET
2014-09-19
PRODUCT MONOGRAPH RATIO-KETOROLAC KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% _ _ _ _ _ _ TOPICAL NON-STEROIDAL ANTI-INFLAMMATORY AGENT RATIOPHARM INC. DATE OF REVISION: CANADA J7J 1P3 NOVEMBER 16, 2009 CONTROL NO. 133966 page 2 PRODUCT MONOGRAPH RATIO-KETOROLAC (ketorolac tromethamine) ophthalmic solution 0.5% _ _ THERAPEUTIC CLASSIFICATION Topical Non-steroidal Anti-Inflammatory Agent _ _ ACTIONS AND CLINICAL PHARMACOLOGY _MECHANISM OF ACTION _ Ketorolac tromethamine is a non-steroidal, anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity mediated by peripheral effects. Ketorolac inhibits the synthesis of prostaglandins through inhibition of the cyclo-oxygenase enzyme system. Prostaglandins play a critical role in many inflammatory processes of the eye and appear to play a role in the miotic response during ocular surgery. At concentrations of 0.02% - 0.5%, ketorolac tromethamine solution did not irritate the eyes of rats, dogs or 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 קרא את המסמך השלם