Product Description.:
NEVANAC? (nepafenac ophthalmic suspension) 0.1% is a sterile, topical, nonsteroidal antiinflammatory (NSAID) prodrug for ophthalmic use. Each mL of NEVANAC ? suspension contains 1 mg of nepafenac.
Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28. NEVANAC?ophthalmic suspension is supplied as a sterile, aqueous 0.1% suspension with a pH approximately of 7.4.
The osmolality of NEVANAC?ophthalmic suspension is approximately 305 mOsmol/kg.
Each mL of NEVANAC? 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.
INDICATIONS
NEVANAC? ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery.
SIDE EFFECTS
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.
Ocular Adverse Reactions
The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients.
Other ocular adverse reactions 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 reactions may be the consequence of the cataract surgical procedure.
Non-Ocular Adverse Reactions
Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.
