Nevanac

Ophthalmological Non-steroidal Anti-inflammatories

For topical application to the eye only.
Shake the container well before use.
If more than 1 medicine is to be administered in the eye, the medicines should be given 5 minutes apart.
Do not administer while wearing contact lens.

ocular hypertension / Delayed / 5.0-10.0
visual impairment / Early / 5.0-10.0
corneal erosion / Delayed / Incidence not known
keratitis / Delayed / Incidence not known

photophobia / Early / 1.0-5.0
conjunctival hyperemia / Early / 1.0-5.0
edema / Delayed / 1.0-5.0
hypertension / Early / 1.0-4.0
contact dermatitis / Delayed / Incidence not known
erythema / Early / Incidence not known
impaired wound healing / Delayed / Incidence not known
bleeding / Early / Incidence not known

foreign body sensation / Rapid / 5.0-10.0
ocular pain / Early / 1.0-5.0
xerophthalmia / Early / 1.0-5.0
lacrimation / Early / 1.0-5.0
ocular irritation / Rapid / 1.0-5.0
ocular pruritus / Rapid / 1.0-5.0
vomiting / Early / 1.0-4.0
headache / Early / 1.0-4.0
nausea / Early / 1.0-4.0
sinusitis / Delayed / 1.0-4.0

ILEVRO, Nevanac

Rx

Ophthalmic NSAID
Used for the treatment of pain and inflammation associated with cataract surgery
May cause increased bleeding of ocular tissues when used in conjunction with ocular surgery

One drop into the affected eye(s) 3 times a day beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period.

One drop into the affected eye(s) once daily beginning 1 day prior to cataract surgery and continued through the first 2 weeks of the postoperative period. On the day of surgery, 1 drop should be administered as usual with an additional drop administered 30—120 minutes prior to surgery.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Nepafenac products.

ILEVRO/Nepafenac/Nevanac Ophthalmic Susp: 0.1%, 0.3%

3 drops/day 0.1% ophthalmic suspension in each affected eye; 1 drop/day 0.3% ophthalmic suspension in each affected eye.

3 drops/day 0.1% ophthalmic suspension in each affected eye; 1 drop/day 0.3% ophthalmic suspension in each affected eye.

3 drops/day 0.1% ophthalmic suspension in each affected eye; 1 drop/day 0.3% ophthalmic suspension in each affected eye.

>= 10 years: 3 drops/day 0.1% ophthalmic suspension in each affected eye; 1 drop/day 0.3% ophthalmic suspension in each affected eye.
< 10 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Mechanism of Action: Following ophthalmic administration, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug (NSAID). The anti-inflammatory and analgesic properties of amfenac are mediated through inhibition of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production. The prostaglandins play a role in the miotic response produced during and after ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In the eye, prostaglandins also have been shown to disrupt the blood-aqueous humor barrier, cause vasodilation, increase vascular permeability, promote leukocytosis, and increase intraocular pressure (IOP). The degree of ocular inflammatory response is correlated with prostaglandin-induced increases in ciliary epithelium permeability. With ophthalmic administration, NSAIDs inhibit the synthesis of prostaglandins in the iris, ciliary body, and conjunctiva, and, thus, work to prevent manifestations of ocular inflammation and reduce pain.The pro-drug structure of nepafenac allows for rapid penetration to the cornea and distribution to target sites, while minimizing surface accumulation and reducing ocular surface complications. While not an FDA-approved indication, topical nepafenac appears to inhibit choroidal neovascularization (CNV) and ischemia-induced retinal neovascularization by decreasing production of vascular endothelial growth factor (VEGF).

Nepafenac is administered topically to the eye. The clinical significance of the systemic absorption of nepafenac after ophthalmic administration is unknown.

Ophthalmic Route
The pro-drug structure allows nepafenac to rapidly penetrate the cornea and reach its target sites, while minimizing surface accumulation and reducing ocular surface complications. Two to three hours after bilateral 0.1% nepafenac ophthalmic administration, given three times daily, low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects. Following ocular administration, the mean steady-state Cmax for nepafenac and for amfenac were 0.310 +/- 0.104 ng/ml and 0.422 +/- 0.121 ng/ml, respectively. The clinical significance of the systemic absorption of nepafenac after ophthalmic administration is unknown.

Nepafenac ophthalmic suspension is classified as an FDA pregnancy risk category C drug. No adequate and well-controlled studies in pregnant women have been performed. The use of nepafenac in pregnant women is only justified if the benefits outweigh the possible risks to the fetus. Because of the possibility of closure of the ductus arteriosus, the use of nepafenac ophthalmic suspension should be avoided in late pregnancy.

According to the manufacturer, caution should be exercised if nepafenac ophthalmic solution is given to a woman who is breast-feeding. It is not known whether nepafenac is excreted in human milk. Systemic concentrations are low after ophthalmic use ; therefore, breast milk concentrations are likely to be very low, if present at all. Although nepafenac has not been evaluated by the American Academy of Pediatrics (AAP), other NSAIDs such as ibuprofen, indomethacin, and naproxen are considered to be usually compatible with breast-feeding by the AAP. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.