BROFIX 0.09% EYE DROPS 5ML

Indications

Approved Uses

Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction

Dosage & Administration

Dosing by Condition

Post‑operative ocular inflammation and pain after cataract surgery (bromfenac 0.09%): instill 1 drop in the affected eye(s) once daily starting 1 day before surgery, continue on the day of surgery, and for 14 days after surgery (or as prescribed).

Initial Dose

1 drop in the affected eye(s) twice daily, beginning 1 day prior to cataract surgery

Maintenance Dose

1 drop in the affected eye(s) once daily for 14 days following cataract surgery

Maximum Dose

1 drop in the affected eye(s) once daily, beginning 1 day prior to cataract surgery, continued on the day of surgery and for 14 days post-surgery.

Children's Dosage

Not approved for children under 18 years of age

Dose Adjustment Notes

No dose adjustment is generally required in renal or hepatic impairment for ophthalmic bromfenac due to minimal systemic absorption; use for the prescribed post‑operative duration and avoid prolonged use unless directed by the ophthalmologist.

How to Take

For ophthalmic use only. Wash hands; shake only if the label instructs (solutions usually do not require shaking). Tilt head back, pull down lower eyelid, instill 1 drop into the affected eye without touching the dropper tip to eye/skin/surfaces. Close eye gently and perform nasolacrimal occlusion (press inner corner) for 1-2 minutes. If using other ophthalmic products, separate by at least 5 minutes (ointments last). Avoid contact lenses unless the prescriber specifically allows (post‑op patients typically should not wear lenses).

Side Effects

Common Side Effects

Common: ocular irritation/burning or stinging on instillation, eye pain, conjunctival hyperemia (redness), blurred vision, eye pruritus/foreign-body sensation; headache can occur.

Side Effect Frequency

Common (≈2-7%): ocular irritation/abnormal sensation (including burning/stinging), conjunctival hyperemia/redness, eye pain, eye pruritus; headache and iritis have been reported. Rare/post-marketing: corneal epithelial breakdown/erosion, corneal thinning, corneal ulceration/perforation.

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to bromfenac, any component of the formulation, or with a history of hypersensitivity reactions to aspirin/other NSAIDs (e.g., asthma, urticaria, acute rhinitis).

Warnings & Precautions

May delay corneal/wound healing; risk of corneal adverse events (thinning, erosion, ulceration, perforation) is higher in patients with complicated ocular surgery, corneal denervation/epithelial defects, diabetes, ocular surface disease (e.g., dry eye), or rheumatoid arthritis; potential cross-sensitivity with aspirin/other NSAIDs; contains sodium sulfite (may cause allergic-type reactions); avoid contact lens wear during treatment; use caution in patients with bleeding tendencies or on anticoagulants/antiplatelets.

Age Restriction

Safety and efficacy have not been established in pediatric patients (<18 years); use is generally not recommended unless a specialist determines benefit outweighs risk.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Concomitant topical NSAIDs and/or topical corticosteroids may increase risk of delayed healing/corneal adverse events; use caution with drugs that prolong bleeding time (e.g., anticoagulants/antiplatelets).

Interaction Severity

MODERATE: Concomitant topical corticosteroids (additive risk of delayed corneal/wound healing). MODERATE: Concomitant topical NSAIDs (increased risk of corneal adverse events/delayed healing). CAUTION/MODERATE: Anticoagulants/antiplatelets in patients with bleeding risk (NSAIDs may increase bleeding tendency, though systemic exposure is low). Practical: separate different eye drops by ≥5 minutes.

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

Not approved for children under 18 years of age

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Missed Dose

Instill the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop early without prescriber advice; complete the prescribed post‑operative course (commonly up to 14 days) unless adverse effects occur or the surgeon instructs otherwise.

Patient Counseling

Use exactly as prescribed (commonly 1 drop once daily for bromfenac 0.09% around cataract surgery). Wash hands; avoid touching the dropper tip; close eye and press inner corner for 1-2 minutes after instillation. If using other eye drops, separate by ≥5 minutes. Expect possible brief burning/stinging or blurred vision; avoid driving until vision clears. Avoid contact lenses unless your surgeon allows. Seek urgent care for severe/worsening eye pain, marked redness, light sensitivity, or vision changes. Store below 30°C (per SFDA).

Monitoring Requirements

Monitor clinically for ocular adverse effects and healing: worsening pain, redness, photophobia, decreased/blurred vision, signs of keratitis/corneal epithelial breakdown, and post‑operative wound healing as assessed by the ophthalmologist.

Pharmacology

Mechanism of Action

Inhibits COX‑1 and COX‑2, decreasing prostaglandin synthesis in ocular tissues, thereby reducing inflammation and pain.

Duration of Effect

Approximately 24 hours of intraocular anti‑inflammatory activity, consistent with once‑daily dosing for 0.09%.

Bioavailability

Low systemic bioavailability after ophthalmic administration; plasma concentrations are generally below the limit of quantification in most patients.

Metabolism

Systemically, bromfenac is primarily metabolized via hepatic CYP2C9 (with subsequent conjugation pathways); after ophthalmic use, systemic metabolism is limited by minimal absorption.

Product Information

Available Dosage Forms

Eye drops, solution (ophthalmic solution).

Composition per Dose

Each 1 mL: Bromfenac sodium 0.9 mg (equivalent to bromfenac 0.09%)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

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