Acuvail (Ketorolac Tromethamine Ophthalmic Solution) Drug Information: Clinical Pharmacology

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May 23, 2012

Acuvail

Cataracts »

Facts about cataracts

A cataract is a clouding of the lens of the eye.
Cataracts are extremely common, and most cataracts are a result of the aging process.
Although many cataracts are not significant enough to require treatment, surgical removal of cataracts is usually safe and effective, resulting in improvement of vision.
Cataract surgery should be performed when the visual loss from the cataract significantly impacts the lifestyle of the individual patient.

What is a cataract?

A cataract is an eye disease in which the clear lens of the eye becomes cloudy opaque, causing decrease in vision. Although the word cataract to describe this condition has been part of the English language only since the middle of the 16th century, the eye disease has been recognized and surgically treated since ancient times.

The lens is a portion of ...

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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.

Pharmacokinetics

The pharmacokinetics of ketorolac tromethamine ophthalmic solution 0.45% have not been assessed in humans.

Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).

One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into 1 eye and 1 drop of vehicle into the other eye TID in 26 normal subjects. Five (5) of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 22 ng/mL) at Day 10 during topical ocular treatment. The range of concentrations following TID dosing of 0.5% ketorolac tromethamine ophthalmic solution are approximately 4 to 8% of the steady state mean minimum plasma concentration observed following four times daily oral administration of 10 mg ketorolac in humans (0.29 ± 0.07 μg/mL).

Clinical Studies

Two multicenter, randomized, double-masked, parallel group comparison studies including approximately 500 patients were conducted to evaluate the effects of ACUVAIL™ (ketorolac tromethamine ophthalmic solution) on anterior chamber cell and flare, and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Results of these studies indicated that patients receiving ACUVAIL™ (ketorolac tromethamine ophthalmic solution) had a significantly higher incidence of clearing of anterior chamber inflammation 53% (167/318) vs. patients receiving vehicle 26% (41/155) at day 14.

ACUVAIL™ (ketorolac tromethamine ophthalmic solution) was also significantly superior to vehicle in resolving ocular pain. On Day 1 post cataract surgery, 72% (233/322) of patients in the ACUVAIL™ (ketorolac tromethamine ophthalmic solution) group were pain free compared to 40% (62/156) of patients in the vehicle group.

Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

Last reviewed on RxList: 8/6/2009
This monograph has been modified to include the generic and brand name in many instances.