Beuflox-D 0.3%+0.1% (Ophthalmic Solution)

Indications

• Treatment of steroid responsive inflammatory ocular conditions
• Post-operative inflammation
• Ear infections accompanied by inflammation
• Otitis externa
• Acute and chronic otitis media

Pharmacology

• Dexamethasone has anti-inflammatory and anti-allergic action
• Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms

Dosage & Administration

• Eye: Instill 1 drop every 4-6 hours, with potential dosage increase in initial 24-48 hours
• Ear (Acute otitis media): 4 drops instilled into affected ear 2 times daily for 7 days
• Ear (Acute otitis externa): 4 drops instilled into affected ear 2 times daily for 7 days
• Pediatric use safety and effectiveness below 1 year not established

Interaction

• Specific drug interaction studies not conducted with ophthalmic Ciprofloxacin and Dexamethasone
• Quinolones may elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance effects of oral anticoagulant warfarin, and transiently elevate serum creatinine in patients receiving cyclosporin concomitantly

Contraindications

• Hypersensitivity to any ingredient of the product
• Herpes simplex and other viral conditions
• Mycosis
• Glaucoma
• Newborn babies
• Fungal diseases of ocular or auricular structures

Side Effects

• Transient ocular burning or discomfort
• Stinging
• Redness
• Itching
• Conjunctivitis/keratitis
• Periocular/facial edema
• Elevation of intraocular pressure (IOP)
• Optic nerve damage
• Posterior subcapsular cataract formation
• Delayed wound healing
• Ear pain
• Irritability
• Dizziness
• Erythema

Pregnancy & Lactation

• Use during pregnancy only if potential benefit justifies potential risk to the fetus
• Caution when using in nursing mothers due to unknown excretion in human milk

Precautions & Warnings

• Consider possibility of fungal infections of the cornea after long-term steroid dosing
• Prolonged use of antibiotic may result in overgrowth of non-susceptible organisms
• Prolonged use of topical ophthalmic steroids may result in glaucoma and cataract formation
• Intraocular pressure should be routinely monitored

Therapeutic Class

• Aural steroid & antibiotic combined preparations

Storage Conditions

• Store in a cool and dry place, away from light
• Keep out of reach of children
• Shake well before each use
• Use within 30 days after first opening
• Close bottle strongly immediately after use

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