ILEVRO- nepafenac suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Nepafenac (UNII: 0J9L7J6V8C) (Nepafenac - UNII:0J9L7J6V8C)

Disponibil de la:

Alcon Laboratories, Inc.

INN (nume internaţional):

Nepafenac

Compoziție:

Nepafenac 3 mg in 1 mL

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

ILEVRO* 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. ILEVRO* 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal 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 70 and 630 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 20 and 180 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 cro

Rezumat produs:

ILEVRO* 0.3% is supplied in a white, oval, low density polyethylene DROP-TAINER® 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. 1.7 mL in 4 mL bottle            NDC 0065-1750-07 3 mL in 4 mL bottle               NDC 0065-1750-14 Storage: Store at 2°C-25°C (36°F-77°F). Protect from light.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

ILEVRO - NEPAFENAC SUSPENSION
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ILEVRO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ILEVRO.
ILEVRO (NEPAFENAC OPHTHALMIC SUSPENSION) 0.3%, TOPICAL OPHTHALMIC
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
ILEVRO 0.3% 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 ILEVRO 0.3% should be applied to the affected eye
one-time-daily beginning 1 day prior to
cataract surgery, continued on the day of surgery and through the
first 2 weeks of the postoperative
period. An additional drop should be administered 30 to 120 minutes
prior to surgery. (2)
DOSAGE FORMS AND STRENGTHS
Sterile ophthalmic suspension 0.3%: 1.7 mL in a 4 mL bottle and 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, 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: 1/2019
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
*
*
*
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6.1 Serious and Otherwise Important Adverse