Nevanac

NEVANAC® (nepafenac ophthalmic suspension) 0.1% is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use. Each mL of NEVANAC® suspension contains 1 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C15H14N2O2. The structural formula of nepafenac is:

Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28. NEVANAC®ophthalmic suspension is supplied as a sterile, aqueous 0.1% suspension with a pH approximately of 7.4.

The osmolality of NEVANAC®ophthalmic suspension is approximately 305 mOsmol/kg.

Each mL of NEVANAC® contains: Active: nepafenac 0.1% Inactives: mannitol, carbomer 974P, sodium chloride, tyloxapol, edetate disodium, benzalkonium chloride 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust pH and purified water, USP.

Dosage Forms and Strengths

Sterile ophthalmic suspension: 0.1%
3 mL in a 4 mL bottle

NEVANAC® (nepafenac ophthalmic suspension) is supplied in a natural, oval, low density polyethylene DROP-TAENER® dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

3 mL in 4 mL bottle NDC 0065-0002-03

Storage: Store at 2 - 25°C (36 - 77°F).

Alcon Laboratories, Inc. Fort Worth, Texas 76134. Revised: 06/2011

Nevanac is a prescription medication used to treat eye pain, redness, and swelling in patients who are recovering from cataract surgery (procedure to treat clouding of the lens in the eye).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• aspirin and other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• corticosteroid eye drops such as dexamethasone (Maxidex), fluorometholone (FML), hydrocortisone (in Cortisporin), loteprednol (Alrex, Lotemax), medrysone (HMS), prednisolone (Pred Mild), and rimexolone (Vexol)

This is not a complete list of Nevanac drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nevanac, there are no specific foods that you must exclude from your diet when receiving this medication.

Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain and inflammation in the eyes.

Nepafenac ophthalmic (for the eyes) is used to reduce pain and swelling after cataract surgery.

Nepafenac ophthalmic may also be used for other purposes not listed in this medication guide.

You should not use nepafenac ophthalmic if you are allergic to it.

To make sure nepafenac ophthalmic is safe for you, tell your doctor if you have:

• diabetes;

• dry eye syndrome;

• an allergy to any other eye drops;

• arthritis; or

• a bleeding or blood-clotting disorder, such as hemophilia.

FDA pregnancy category C. It is not known whether nepafenac ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether nepafenac ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Contraindications

• Known hypersensitivity to nepafenac or any ingredient in the formulation or to other NSAIAs.1

Warnings/Precautions

Warnings

May inhibit platelet aggregation and prolong bleeding time.1

May cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery.1

Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.1

Sensitivity Reactions

Possible cross-sensitivity with aspirin, phenylacetic acid derivatives, and other NSAIAs.1 Use with caution in patients with history of hypersensitivity to these drugs.1

General Precautions

May slow or delay wound healing.1 (See Specific Drugs under Interactions.)

Use may result in keratitis.1 In some susceptible patients, continued use may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation; these events may be sight-threatening.1 If manifestations of corneal epithelial breakdown occur, discontinue therapy immediately and monitor for corneal health.1

Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for developing adverse corneal effects that may become sight-threatening.1 Use with caution in these patients.1

Use >1 day prior to surgery or use beyond 14 days postoperatively may precipitate or exacerbate adverse corneal effects.1

No substantial effect on intraocular pressure reported; however, changes in intraocular pressure may occur following cataract surgery.1

Specific Populations

Category C.1

Avoid use in late pregnancy because of known effects on fetal cardiovascular system (possible closure of the ductus arteriosus).1

Distributed into milk in rats following oral administration of a single 3 mg/kg-dose;1 9 not known whether distributed into human milk following ophthalmic administration.1 Use with caution.1

Safety and efficacy not established in children <10 years of age.1

No substantial differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Capsular opacity, decreased visual acuity, ocular foreign body sensation, increased intraocular pressure, ocular sticky sensation, conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, vitreous detachment, headache, hypertension, nausea, vomiting, sinusitis.1

Does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 in vitro.1

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 unlikely.1

Protein-bound Drugs

Pharmacokinetic interaction unlikely.1

Specific Drugs

Storage

Ophthalmic

2–25°C.1

Slow or Delayed Healing

Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

Avoiding Contamination of the Product

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

Contact Lens Wear

Nevanac® should not be administered while wearing contact lens.

Intercurrent Ocular Conditions

Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of the multi-dose container.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Shake Well Before Use

Patients should be advised to shake the bottle well.

U.S. Patent No; 5,475,034 and 7,834,059.

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

©2007, 2008, 2011 Novartis AG

9006966-0711

Applies to nepafenac ophthalmic: ophthalmic suspension

Along with its needed effects, nepafenac ophthalmic (the active ingredient contained in Nevanac) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nepafenac ophthalmic:

• Blurred vision
• change in vision
• decrease in vision
• loss of vision

• Eye pain
• itching of the eye
• swelling and/or redness of the eye and lining of the eyelid

Some side effects of nepafenac ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Feeling of having something in the eye
• sticky sensation of the eyelids

• Change in color vision
• cough
• crusting in the corner of the eye
• difficulty seeing at night
• dizziness
• dry eyes
• fever
• headache
• increased sensitivity of the eyes to sunlight
• nausea or vomiting
• nervousness
• pounding in the ears
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• slow or fast heartbeat
• stuffy or runny nose
• tenderness around the eyes and cheekbones
• tightness of the chest or wheezing
• troubled breathing