nepafenac ophthalmic (Rx)

1-10%

Capsular opacity (5-10%)

Decreased visual acuity (5-10%)

Foreign body sensation (5-10%)

Increased IOP (5-10%)

Sticky sensation (5-10%)

Conjunctival edema (1-5%)

Corneal edema (1-5%)

Dry eye (1-5%)

Headache (1-4%)

HTN (1-4%)

Lid margin crusting (1-5%)

N/V (1-4%)

Ocular discomfort (1-5%)

Ocular hyperemia (1-5%)

Ocular pain (1-5%)

Ocular pruritus (1-5%)

Photophobia (1-5%)

Tearing (1-5%)

Vitreous detachment (1-5%)

Postmarketing Reports

Increased bleeding time

Delayed effects

Contraindications

Hypersensitivity to NSAIDs or any ingredients

Cautions

Sensitivity to aspirin or phenylacetic acid deivatives

May cause increased bleeding in ocular tissues

May cause keratitis & corneal damage (risk increased if applied earlier than 1 day presurgery or longer than 2 wk postsurgery)

Use caution in patients with bleeding predisposition, ocular disease states, diabetes ( corneal adverse effects may result in loss of vision), rheumatoid arthritis

Do not wear contact lenses while on the medication

Risk of corneal adverse effects increases with use 1 day before surgery or >14 days following surgery

Pregnancy Category: C

Lactation: Unknown if excreted in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Non-steroidal anti-inflammatory prodrug, converted to amfenac which putatively inhibits prostaglandin biosynthesis

Absorption

Absoption: Low systemic absorption

Peak Plasma: nepafenac 0.31 ng/mL; amfenac: 0.42 ng/mL