NEVANAC- nepafenac suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEPAFENAC (UNII: 0J9L7J6V8C) (NEPAFENAC - UNII:0J9L7J6V8C)

Available from:

Physicians Total Care, Inc.

INN (International Name):

NEPAFENAC

Composition:

NEPAFENAC 1 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NEVANAC® ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery. NEVANAC® is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs. Enter section text here 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 placent

Authorization status:

New Drug Application

Summary of Product characteristics

NEVANAC - NEPAFENAC SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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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
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2011
FULL PRESCRIBING INFORMATION: CONTENTS*
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