HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use nevanac safely and effectively. See full prescribing information for nevanac.
nevanac (nepafenac) suspension for ophthalmic use
Initial U.S. Approval: 2005
INDICATIONS AND USAGE
NEVANAC®ophthalmic suspension is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1)
DOSAGE AND ADMINISTRATION
One drop of NEVANAC® 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. ( 2)
DOSAGE FORMS AND STRENGTHS
Sterile ophthalmic suspension: 0.1% ( 3)
3 mL in a 4 mL bottle
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in the formula or to other NSAIDS.( 4)
WARNINGS AND PRECAUTIONS
Increased bleeding time due to increased thrombocyte aggregation ( 5.1)
Delayed healing ( 5.2)
Corneal effects including keratitis ( 5.3)
ADVERSE REACTIONS
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
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION
Revised: 05/2008
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Use with Other Topical Ophthalmic Medications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Increased Bleeding Time
5.2 Delayed Healing
5.3 Corneal Effects
5.4 Contact Lens Wear
6 ADVERSE REACTIONS
6.1 Ocular Adverse Reactions
6.2 Non-Ocular Adverse Reactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Slow or Delayed Healing
17.2 Avoiding Contamination of the Product
17.3 Contact Lens Wear
17.4 Intercurrent Ocular Conditions
17.5 Concomitant Topical Ocular Therapy
17.6 Shake Well Before Use
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
NEVANAC® ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
One drop of NEVANAC® should b