NU-KETOROLAC OPHTHALMIC SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

KETOROLAC TROMETHAMINE

Disponible depuis:

NU-PHARM INC

Code ATC:

S01BC05

DCI (Dénomination commune internationale):

KETOROLAC

Dosage:

0.5%

forme pharmaceutique:

SOLUTION

Composition:

KETOROLAC TROMETHAMINE 0.5%

Mode d'administration:

OPHTHALMIC

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED (UNRETURNED ANNUAL)

Date de l'autorisation:

2018-03-28

Résumé des caractéristiques du produit

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
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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_.
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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