COMPOSITION

NEPATOP™ contains Nepafenac 0.1% in an advanced 4th Generation Ophthalmic Suspension.

DESCRIPTION

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

CLINICAL PHARMACOLOGY

Pharmacodynamics

NEPATOP™ 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 AND USAGE
NEPATOP 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 NEPATOP ™ 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 AND STRENGTHS
Sterile ophthalmic suspension:  0.1%

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.

HOW SUPPLIED

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

STORAGE

Store in a cool dry place. Protect from light.

FOR EXTERNAL USE ONLY

SHAKE WELL BEFORE USE

NOT FOR INJECTION