Nevanac Information
Nevanac (Nepafenac) Indications And Usage
Nevanac (Nepafenac) ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery.
Nevanac (Nepafenac) Dosage Forms And Strengths
Sterile ophthalmic suspension: 0.1%
3 mL in a 4 mL bottle
Nevanac (Nepafenac) Contraindications
Nevanac (Nepafenac) is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDS.
Nevanac (Nepafenac) Warnings And Precautions
With some nonsteroidal anti-inflammatory drugs including Nevanac (Nepafenac) , there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
It is recommended that Nevanac (Nepafenac) ophthalmic suspension be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including Nevanac (Nepafenac) and should be closely monitored for corneal health.
Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.
Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk for occurrence and severity of corneal adverse events.
Nevanac (Nepafenac) Adverse Reactions
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The most frequently reported ocular adverse events following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately 5 to 10% of patients.
Other ocular adverse events occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment.
Some of these events may be the consequence of the cataract surgical procedure.
Nevanac (Nepafenac) Drug Interactions
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 CYPmediated metabolism of concomitantly administered drugs are unlikely. Drug-drug interactions mediated by protein binding are also unlikely.
Nevanac (Nepafenac) Description
Nevanac (Nepafenac) (nepafenac ophthalmic suspension) 0.1% is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use. Each mL of Nevanac (Nepafenac) suspension contains 1 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of CHNO. The structural formula of nepafenac is:
Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28. Nevanac (Nepafenac) ophthalmic suspension is supplied as a sterile, aqueous 0.1% suspension with a pH approximately of 7.4.
The osmolality of Nevanac (Nepafenac) ophthalmic suspension is approximately 305 mOsmol/kg.
Each mL of Nevanac (Nepafenac) contains: Active: nepafenac 0.1% Inactives: mannitol, carbomer 974P, sodium chloride, tyloxapol, edetate disodium, benzalkonium chloride 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust pH and purified water, USP.
Nevanac (Nepafenac) Clinical Pharmacology
Gender: Data in healthy subjects indicate no clinically relevant or significant gender difference in the steady-state pharmacokinetics of amfenac following three-times-daily dosing of Nevanac (Nepafenac) .
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.
Nevanac (Nepafenac) 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 (Nepafenac) ophthalmic suspension demonstrated clinical efficacy, compared to its vehicle in treating postoperative inflammation.
Patients treated with Nevanac (Nepafenac) 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 (Nepafenac) has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.
Nevanac (Nepafenac) How Supplied/storage And Handling
Nevanac (Nepafenac) (nepafenac ophthalmic suspension) is supplied in a natural, oval, low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
3 mL in 4 mL bottle NDC 0065-0002-03
Nevanac (Nepafenac) Patient Counseling Information
Patients should be advised to shake the bottle well.
U.S. Patent No; 5,475,034
ALCON®
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2007 Alcon, Inc.
