BROMFENAC solution/ drops

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Akorn

INN (nume internaţional):

BROMFENAC SODIUM

Compoziție:

BROMFENAC 1.035 mg in 1 mL

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. None. Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. 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 (cl

Rezumat produs:

Bromfenac Ophthalmic Solution 0.09% is supplied in a white LDPE plastic squeeze bottle with a LDPE white dropper-tip and polypropylene gray cap as follows: 1.7 mL in 6 mL container Store at 20º - 25ºC (68º - 77ºF) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

BROMFENAC- BROMFENAC SOLUTION/ DROPS
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BROMFENAC OPHTHALMIC
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BROMFENAC.
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Bromfenac 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 extraction (1). (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). (2)
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution: bromfenac 0.09% (3) (3)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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ADVERSE REACTIONS
The most commonly reported adverse reactions in 2-7% of patients were
abnormal sensation in eye,
conjunctival hyperemia and eye irritation (including burning/stinging)
(6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HI-TECH PHARMACAL CO.,
INC. AT 1-800-
262-9010 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2022
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
6.2 Post-Marketing Experience
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)
6.2 Post-Marketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Ped