CLINICAL PHARMACOLOGY
Mechanism of Action
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis. Ketorolac tromethamine given systemically does not cause pupil constriction.
Pharmacokinetics
One drop (0.05 mL) of 0.5% ketorolac tromethamine ophthalmic solution was instilled into one eye and one drop of vehicle into the other eye TID in 26 normal subjects. Only 5 of 26 subjects had a detectable amount of ketorolac in their plasma (range 10.7 to 22.5 ng/mL) at day 10 during topical ocular treatment. When ketorolac tromethamine 10 mg is administered systemically every 6 hours, peak plasma levels at steady state are around 960 ng/mL.
Clinical Studies
In two double-masked, multi-centered, parallel-group studies, 313 patients who had undergone photorefractive keratectomy received ACULAR LS ® 0.4% or its vehicle QID for up to 4 days. Significant differences favored ACULAR LS ® for the reduction of ocular pain and burning/stinging following photorefractive keratectomy surgery.
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure.
The safety and effectiveness of ACULAR LS ® in post-cataract surgery patients has not been established.
|
