Nevanac (Nepafenac Ophthalmic Suspension) Drug Information: Clinical Pharmacology

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May 27, 2012

Nevanac

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

After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

Pharmacokinetics

Low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours postdose, respectively, following bilateral topical ocular three-times-daily dosing of nepafenac ophthalmic suspension, 0.1%. The mean steady-state Cmax for nepafenac and for amfenac were 0.310 ± 0.104 ng/ml and 0.422 ±0.121 ng/ml, respectively, following ocular administration.

Nepafenac at concentrations up to 300 ng/mL did not inhibit the in vitro metabolism of 6 specific marker substrates of cytochrome P450 (CYP) isozymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4). Therefore, drug-drug interactions involving CYP mediated metabolism of concomitantly administered drugs are unlikely. Drug-drug interactions mediated by protein binding are also unlikely.

Clinical Studies

In two double-masked, randomized clinical trials in which patients were dosed three-times-daily beginning one day prior to cataract surgery, continued on the day of surgery and for the first two weeks of the postoperative period, NEVANAC® ophthalmic suspension demonstrated clinical efficacy, compared to its vehicle in treating postoperative inflammation.

Patients treated with NEVANAC® ophthalmic suspension were less likely to have ocular pain and measurable signs of inflammation (cells and flare) in the early postoperative period through the end of treatment than those treated with its vehicle.

For ocular pain in both studies a significantly higher percentage of patients (approximately 80%) in the nepafenac group reported no ocular pain on the day following cataract surgery (Day 1) compared to those in the vehicle group (approximately 50%).

Results from clinical studies indicated that NEVANAC® has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

Last reviewed on RxList: 7/29/2011
This monograph has been modified to include the generic and brand name in many instances.