NEVANAC nepafenac suspension

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:

1 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Summary of Product characteristics

NEVANAC- NEPAFENAC SUSPENSION
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RECENT MAJOR CHANGES
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
NEVANAC is contraindicated in patients with previously demonstrated
hypersensitivity to any of the ingredients in the
formula or to other NSAIDS. (4)
WARNINGS AND PRECAUTIONS
NEVANAC has a potential for cross-sensitivity to acetylsalicylic acid,
phenylacetic acid derivatives and other nonsteriodal
anti-inflammatory agents (5.1)
NEVANAC may increase Bleeding Time due to increased thrombocyte
aggregation (5.2)
NEVANAC may slow or delay healing (5.3) and may result in keratitis
(5.4)
ADVERSE REACTIONS
Most common adverse reactions (5 to 10%) are capsular opacity,
decreased visual acuity, foreign body sensation,
increased intraocular pressure, and sticky sensation. ocular hyperemia
and ocular pruritus (6.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2008
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 Cross-Sensitivity
5.2 Bleeding Time
5.3 Delayed Healing
5.4 Corneal Effects
5.5 Contact Lens Wear
6 ADVERSE REACTIONS
6.1 Ocular Adverse Reactions
6.2 Non-Ocular Adverse Reactions
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS SECTION
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOG