NEVANAC 1/MG EYE DROPS 5ML

Indications

Approved Uses

Treatment of pain and inflammation associated with cataract surgery.

Off-Label Uses

Prevention/treatment of pseudophakic cystoid macular edema (including in higher-risk patients such as diabetes) is a common off-label use; other proposed uses (e.g., uveitis) are less established and should be specialist-directed.

Dosage & Administration

Dosing by Condition

Cataract surgery pain/inflammation (nepafenac 0.1%): Instill 1 drop in the affected eye(s) three times daily starting 1 day before surgery, on the day of surgery, and for 2 weeks after surgery; instill 1 additional drop 30-120 minutes before surgery.

Initial Dose

One drop in the affected eye(s) three times daily, beginning 1 day before cataract surgery.

Children's Dosage

Safety and effectiveness in pediatric patients have not been established.

How to Prepare

Shake well before each use; no reconstitution required.

Side Effects

Side Effect Frequency

Common (1-10%): capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, ocular pain/discomfort; keratitis/punctate keratitis can occur. Less common/uncommon: corneal epithelial defect/keratitis; rare but serious: corneal ulceration/thinning/perforation (especially with risk factors).

Safety & Warnings

Warnings & Precautions

Shake well (suspension); avoid contact lenses during treatment; may delay healing and increase bleeding; cross‑sensitivity with aspirin/other NSAIDs; use caution in patients with corneal compromise (e.g., epithelial defects, diabetes, ocular surface disease, rheumatoid arthritis), complicated/repeat ocular surgery, or concomitant topical steroids/NSAIDs.

Age Restriction

Safety and effectiveness have not been established in pediatric patients (no approved pediatric age; use only if specialist deems necessary).

Drug Interactions

Drug Interactions

Additive risk with topical NSAIDs and with topical corticosteroids (healing/corneal risk); caution with drugs that prolong bleeding time (e.g., warfarin/antiplatelets); separate different ophthalmic drops by at least 5 minutes.

Interaction Severity

MODERATE: Concomitant topical NSAIDs and/or topical corticosteroids (increased risk of corneal adverse events and delayed healing). CAUTION: Agents affecting bleeding (e.g., anticoagulants/antiplatelets) may increase ocular bleeding risk around surgery. MINOR/ADMIN: Other eye drops may be washed out if not spaced by ≥5 minutes.

Special Populations

Children

Safety and effectiveness in pediatric patients have not been established.

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Storage Conditions

Do not store above 30°C; do not freeze; discard 4 weeks (28 days) after first opening.

Preparation Instructions

Shake well before each use; no reconstitution required.

Stopping the Medicine

Do not stop early without the prescriber; complete the prescribed post‑operative course (commonly up to ~2 weeks after cataract surgery) unless adverse effects occur.

Pharmacology

Mechanism of Action

Nepafenac is a prodrug that penetrates the cornea and is converted to amfenac, which inhibits cyclooxygenase (COX-1/COX-2; prostaglandin H synthase), reducing prostaglandin synthesis and ocular inflammation/pain.

Onset of Action

Analgesic effect may begin within 15-30 minutes; anti-inflammatory benefit develops over hours to days with continued dosing.

Duration of Effect

Not well-defined as a single per-dose duration; clinical effect is maintained with TID dosing.

Bioavailability

Low systemic absorption after ophthalmic administration; plasma levels are typically very low (often below quantification) with standard dosing.

Metabolism

Nepafenac is a prodrug converted by intraocular hydrolases to the active metabolite amfenac; any absorbed drug is further metabolized systemically.

Product Information

Available Dosage Forms

Eye drops, suspension (ophthalmic suspension).

Composition per Dose

Each mL of suspension: Nepafenac 1 mg (1 mg/mL)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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