Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 04 September 2018

Indication(s)

1 INDICATIONS AND USAGE NEVANAC* (nepafenac ophthalmic suspension), 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery. NEVANAC (nepafenac ophthalmic suspension), 0.1% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery (1)

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Migraine Knowledge Centre

Migraine Knowledge Centre

The Migraine Knowledge Centre features latest research on the prevalence and impact of migraine, the proposed neurological basis of the condition (and how this is being translated into new and exciting drug therapies), as well as current patient care strategies collated from headache organisations worldwide.

Atopic Dermatitis

Atopic Dermatitis

The Atopic Dermatitis Knowledge Centre is an educational resource, intended for healthcare professionals, that provides credible medical information on the epidemiology, pathophysiology and burden of atopic dermatitis, as well as diagnostic techniques, treatment regimens and guideline recommendations.

Load more

Related Content

Advisory information

contraindications
4 CONTRAINDICATIONS NEVANAC (nepafenac ophthalmic suspension), 0.1% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDs). Hypersensitivity to any of the ingredients in the formula or to other NSAIDS. (4)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of labeling: Increased Bleeding Time [see Warnings and Precautions (5.1)] Delayed Healing [see Warnings and Precautions (5.2)] Corneal Effects [see Warnings and Precautions (5.3)] Most common adverse reactions (5 to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure and sticky sensation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these reactions may be the consequence of the cataract surgical procedure. Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION One drop of NEVANAC (nepafenac ophthalmic suspension), 0.1% should be applied to the affected eye 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. (2) 2.1 Recommended Dosing One drop of NEVANAC (nepafenac ophthalmic suspension), 0.1% should be applied to the affected eye 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. Shake the container well prior to dosing. 2.2 Use with Other Topical Ophthalmic Medications NEVANAC (nepafenac ophthalmic suspension), 0.1% may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 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 greater than or equal to 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 (nepafenac ophthalmic suspension), 0.1% 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 (nepafenac ophthalmic suspension), 0.1% during late pregnancy should be avoided. 8.3 Nursing Mothers Nepafenac 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 (nepafenac ophthalmic suspension), 0.1% ophthalmic suspension is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of NEVANAC (nepafenac ophthalmic suspension), 0.1% in pediatric patients below the age of 10 years have not been established. 8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Pregnancy and lactation
8.3 Nursing Mothers Nepafenac 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 (nepafenac ophthalmic suspension), 0.1% ophthalmic suspension is administered to a nursing woman.

More information

Category Value
Authorisation number NDA021862
Agency product number 0J9L7J6V8C
Orphan designation No
Product NDC 0065-0002
Date Last Revised 15-12-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 603978
Marketing authorisation holder Alcon Laboratories, Inc.