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bromfenac sodium 0.09% eye drp

In stock Manufacturer HI-TECH/AKORN C 50383024971
$325.07 / 1.7 Milliliters Drop Btl

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Uses

Postoperative Ocular Inflammation and Pain

Bromfenac sodium is used for the management of postoperative ocular inflammation and pain in patients who have undergone cataract extraction.

Safety and efficacy of bromfenac sodium have been evaluated in 2 randomized, double-blind, placebo-controlled studies in 527 patients who had undergone cataract surgery. In these studies, patients with a summed ocular inflammation score of 3 or higher after cataract surgery were randomized in a 2:1 ratio to receive either bromfenac 0.09% ophthalmic solution (1 drop twice daily) or vehicle for 14 days, beginning the day after surgery. At 14 days postoperatively, ocular inflammation was reduced to a level considered trace or clearing in more patients who received bromfenac (62-66%) than in those who received vehicle (40-48%). Ocular pain, tearing, foreign body sensation, and photophobia were reported in fewer patients who received bromfenac than in those who received vehicle. Among the 20% of patients who experienced ocular pain on the first day after surgery, the median time for resolution was 2 days for those treated with bromfenac compared with 4 days for those treated with vehicle.

Dosage and Administration

Administration

Bromfenac sodium is applied topically to the eye as an ophthalmic solution. Care should be taken to avoid contamination of the solution container.

Bromfenac sodium ophthalmic solution should not be administered while wearing contact lenses.

Dosage

Dosage of bromfenac sodium, which is commercially available as the sesquihydrate, is expressed in terms of bromfenac.

The recommended adult dosage of bromfenac for the management of postoperative ocular inflammation and pain in patients who have undergone cataract extraction is 1 drop of a 0.09% solution in the affected eye(s) twice daily, beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

Special Populations

No special population recommendations at this time.

Cautions

Contraindications

Known hypersensitivity to bromfenac sodium or any ingredient in the formulation.

Warnings/Precautions

Warnings

Bleeding

NSAIAs may inhibit platelet aggregation and prolong bleeding time. Some reports indicate that ophthalmic NSAIAs may cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery. Ophthalmic NSAIAs, including bromfenac sodium, should be used with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.

Sensitivity Reactions

Hypersensitivity Reactions

Cross-sensitivity may exist with aspirin, phenylacetic acid derivatives, and other NSAIAs. Bromfenac sodium ophthalmic solution should be used with caution in patients with a history of hypersensitivity to these drugs. For further discussion of cross-sensitivity of NSAIAs,

Sulfite Sensitivity

Bromfenac sodium ophthalmic solution contains sodium sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low; however, such sensitivity appears to occur more frequently in asthmatic than in nonasthmatic individuals.

General Precautions

Wound-healing Complications

All topical NSAIAs may slow or delay wound healing.(See Drug Interactions: Topical Corticosteroids.)

Ocular Effects

Use of topical NSAIAs may result in keratitis. In some susceptible patients, continued use of topical NSAIAs also may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation; these events may be sight-threatening. Patients presenting with evidence of corneal epithelial breakdown should be advised to discontinue topical NSAIA therapy immediately and should be closely monitored for corneal health.

Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for developing adverse corneal effects that may become sight-threatening. Topical NSAIAs should be used with caution in these patients.

Use of topical NSAIAs more than 24 hours prior to surgery or use beyond 14 days postoperatively may precipitate or exacerbate adverse corneal effects.

Specific Populations

Pregnancy

Category C. Avoid use in late pregnancy (i.e., third trimester) because of known effects on fetal cardiovascular system (possible premature closure of the ductus arteriosus).

Lactation

Not known whether bromfenac is distributed into milk following topical application to the eye. Caution if used in nursing women.

Pediatric Use

Safety and efficacy not established in children younger than 18 years of age.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Adverse effects reported in 2% or more of patients receiving bromfenac sodium ophthalmic solution include abnormal ocular sensation, conjunctival hyperemia, ocular redness or irritation (e.g., pruritus, burning, stinging, pain), headache, and iritis.

Drug Interactions

No formal drug interaction studies have been performed to date.

Topical Corticosteroids

Potential pharmacologic interaction (increased potential for wound-healing complications). (See Wound-healing Complications under Warnings/Precautions: General Precautions, in Cautions.)

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