BROMFENAC SODIUM solution/ drops

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

BROMFENAC SODIUM (UNII: 8ECV571Y37) (BROMFENAC - UNII:864P0921DW)

Disponibbli minn:

Lupin Pharmaceuticals, Inc.

Rotta amministrattiva:

OPHTHALMIC

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. None Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. However, embryo-fetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality and reduced postnatal growth at 0.9 mg/kg/day. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. Caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman. Safety and efficacy in pediatric patients below the age of 18 years have not been established. There is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 70 years of age and older compared to younger adult patients.

Sommarju tal-prodott:

Bromfenac Ophthalmic Solution, 0.07% is supplied in a white low density polyethylene bottle fitted with a white low density polyethylene nozzle and sealed with grey colored high density polyethylene cap with tamper-evident ring as follows: Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BROMFENAC SODIUM- BROMFENAC SODIUM SOLUTION/ DROPS
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BROMFENAC
OPHTHALMIC SOLUTION 0.07% SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR BROMFENAC OPHTHALMIC SOLUTION.
BROMFENAC OPHTHALMIC SOLUTION 0.07%
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug
(NSAID) indicated for the
treatment of postoperative inflammation and reduction of ocular pain
in patients who have undergone
cataract surgery. (1)
DOSAGE AND ADMINISTRATION
Instill one drop into the affected eye once daily beginning 1 day
prior to surgery, continued on the day of
surgery, and through the first 14 days post-surgery. (2.1)
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution: bromfenac 0.07 % (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Sulfite Allergic Reactions (5.1)
Slow or Delayed Healing (5.2)
Potential for cross-sensitivity (5.3)
Increase bleeding of ocular tissues (5.4)
Corneal effects including keratitis (5.5)
Contact Lens Wear (5.6)
ADVERSE REACTIONS
The most commonly reported adverse reactions in 3 to 8 % of patients
were anterior chamber
inflammation, foreign body sensation, eye pain, photophobia, and
vision blurred. (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2024
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 Sulfite Allergic Reactions
5.2 Slow or Delayed Healing
5.3 Potential for Cross-Sensitivity
5.4 Increased Bleeding Time
5.5 Keratitis and Corneal Reactions
5.6 Contact Lens Wear
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
8 USE IN SPECIFIC P