RATIO-KETOROLAC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC code:

S01BC05

INN (International Name):

KETOROLAC

Dosage:

0.5%

Pharmaceutical form:

SOLUTION

Composition:

KETOROLAC TROMETHAMINE 0.5%

Administration route:

OPHTHALMIC

Units in package:

5/10ML

Prescription type:

Prescription

Therapeutic area:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0121995003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-09-19

Summary of Product characteristics

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