NSAIDs

NEPANOVA Eye Drops

Description:

NEPANOVA is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use.

Clinical Pharmacology

Pharmacodynamics

NEPANOVA contains nepafenac (0.1%), a nonsteroidal anti-inflammatory and analgesic prodrug. 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.

Indications & Usage:

NEPANOVA- ophthalmic suspension is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.

Dosage and Administration:

One drop of NEPANOVA ophthalmic suspension should be applied to the affected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period.

Dosage Forms & Strengths:

Sterile ophthalmic suspension: 0.1% in an 5ml FFS bottle.

Contraindications:

Hypersensitivity to any of the ingredients in the formula or to other NSAIDS.

Warnings and Precautions:

Increased bleeding time due to increased thrombocyte aggregation.

Delayed healing.

Corneal effects including keratitis.

Adverse Reactions:

Most common adverse reactions (5 to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.

Storage:

Store in a cool dry place. Protect from direct light.

Presentation:

NEPANOVA is supplied in a 5ml three-piece plastic vial of white opaque color.