NEVANAC- nepafenac suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alcon Laboratories, Inc.

INN (International Name):

NEPAFENAC

Composition:

NEPAFENAC 1 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NEVANAC® 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery. NEVANAC 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). 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 post-implantation loss, reduced fetal weights and growth, and reduced fetal survival. Nepafenac has been shown to cross

Product summary:

NEVANAC® 0.1% is supplied in a white, oval, low density polyethylene dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. The 1.7 mL fill is presented in an overwrap, which provides tamper evidence to the package. Tamper evidence for the 3 mL fill is provided with a shrink band around the closure and neck area of the package. 3 mL in a 4 mL bottle……………………………………………………………………………NDC 0065-0002-03 Storage: Store at 2°C to 25°C (36°F to 77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

NEVANAC- NEPAFENAC SUSPENSION/ DROPS
ALCON LABORATORIES, INC.
----------
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 OPHTHALMIC SUSPENSION) 0.1%, FOR TOPICAL OPHTHALMIC
USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
NEVANAC 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 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 (2.1)
DOSAGE FORMS AND STRENGTHS
Sterile ophthalmic suspension 0.1%
3 mL in a 4 mL bottle (3)
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in the formula or to other
non-steroidal anti-inflammatory drugs
(NSAIDS) (4)
WARNINGS AND PRECAUTIONS
Increased bleeding time due to interference with 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 (IOP), and sticky sensation
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS
PHARMACEUTICALS CORPORATION
AT 1-888-669-6682 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2020
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 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric