Nevanac

Name: Nevanac

Nevanac and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

Nevanac has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Nevanac, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Nepafenac ophthalmic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • vision problems;

  • crusting or drainage of your eyes;

  • swollen eyelids; or

  • severe eye pain.

Other common side effects may be more likely to occur (some are effects of cataract surgery and not side effects of the medication):

  • dry or sticky feeling in the eye;

  • feeling like something is in your eye;

  • eye redness;

  • itching or watering of the eye;

  • increased sensitivity to light;

  • headache;

  • nausea, vomiting; or

  • stuffy nose.

What other drugs will affect nepafenac ophthalmic?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with nepafenac ophthalmic, especially other steroid eye drops.

It is not likely that other drugs you take orally or inject will have an effect on nepafenac used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Introduction

Prodrug of amfenac, a prototypical NSAIA.1 2 3 4 5 6 7 8

Precautions While Using Nevanac

Your eye doctor will check your or your child's eyes at regular visits to make sure it is working properly and is not causing unwanted effects.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

Slow or delayed healing may occur while you or your child are using this medicine. Ask your doctor before using this medicine together with a topical corticosteroid (eg, betamethasone, hydrocortisone).

Using this medicine may increase risk of having corneal (front part of the eye) problems, including keratitis. Check with your eye doctor right away if you or your child have blurred vision, changes in vision, or eye redness, irritation, or pain while using this medicine.

Make sure your doctor knows if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.

If you hurt your eye or develop an eye infection, talk with your doctor right away. You may need to change your medicine or stop using it.

Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Dosage Forms and Strengths

Sterile ophthalmic suspension: 0.1%

3 mL in a 4 mL bottle

Use in specific populations

Pregnancy

Teratogenic Effects.

Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 260 and 2400 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 80 and 680 times human plasma exposure for rabbits, respectively. In rats, maternally toxic doses =10 mg/kg were associated with dystocia, increased postimplantation loss, reduced fetal weights and growth, and reduced fetal survival.

Nepafenac has been shown to cross the placental barrier in rats. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Nevanac® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Non-teratogenic Effects.

Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Nevanac® during late pregnancy should be avoided.

Nursing Mothers

Nevanac® is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nevanac® ophthalmic suspension is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Nevanac® in pediatric patients below the age of 10 years have not been established.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

How Supplied/Storage and Handling

Nevanac® (nepafenac ophthalmic suspension) is supplied in a natural, oval, low density polyethylene DROP-TAINER® 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).

Principal display panel

NDC 0065-0002-03      STERILE

Nevanac®
(nepafenac ophthalmic suspension) 0.1%

3 mL

Alcon®

Rx Only

FOR TOPICAL OPHTHALMIC USE ONLY

USUAL DOSAGE: Instill one drop in the affected eye three times daily.

SHAKE WELL BEFORE USING.

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

U.S. Patent Nos. 5,475,034 and 7,834,059.

Each mL 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.

Alcon®
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, Texas 76134 USA
1-800-757-9195
MedInfo@AlconLabs.com
Printed in USA
©2005, 2006, 2009, 2011 Novartis AG

9006967-0711

LOT:

EXP.:

NDC 0065-0002-03

Nevanac®(nepafenac ophthalmic suspension) 0.1%

3 mL

Each mL contains:
Active: nepafenac 0.1%
Storage: Store at 2° - 25°C (36° - 77°F).

Usual Dosage: Read insert.

Rx Only

STERILE

ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA
©2005, 2011 Novartis AG

LOT:
EXP.:

H13585-0514

Nevanac  
nepafenac suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0002
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEPAFENAC (NEPAFENAC) NEPAFENAC 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
MANNITOL  
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)  
SODIUM CHLORIDE  
TYLOXAPOL  
EDETATE DISODIUM  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0065-0002-03 3 mL in 1 BOTTLE, PLASTIC
2 NDC:0065-0002-01 1.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021862 09/06/2005
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Research Ltd (007672236)
Establishment
Name Address ID/FEI Operations
Alcon Research Ltd 007672236 MANUFACTURE(0065-0002)
Revised: 10/2011   Alcon Laboratories, Inc.

Important information

You should not use Nevanac if you are allergic to nepafenac.

Before using Nevanac, tell your doctor if you are allergic to any other eye drops, or if you have diabetes, dry eye syndrome, arthritis, or a bleeding or blood-clotting disorder, such as hemophilia.

Do not use Nevanac for longer than 14 days after your surgery unless your doctor tells you to.

Do not use this medication while wearing contact lenses. Nevanac may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Before using Nevanac

You should not use Nevanac if you are allergic to nepafenac.

To make sure Nevanac 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 Nevanac 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 passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Nevanac side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Nevanac: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • vision problems;

  • crusting or drainage of your eyes;

  • swollen eyelids; or

  • severe eye pain.

Other common Nevanac side effects may be more likely to occur (some are effects of cataract surgery and not side effects of the medication):

  • dry or sticky feeling in the eye;

  • feeling like something is in your eye;

  • eye redness;

  • itching or watering of the eye;

  • increased sensitivity to light;

  • headache;

  • nausea, vomiting; or

  • stuffy nose.

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