Besibac 0.6% (Ophthalmic Suspension)

Indications

• Treatment of bacterial conjunctivitis caused by susceptible isolates of specific bacteria
• Efficacy studied in fewer than 10 infections

Pharmacology

• Active ingredient: Besifloxacin
• Activity against Gram-positive and Gram-negative bacteria
• Inhibition of bacterial DNA gyrase and topoisomerase IV
• Essential enzyme for replication, transcription, and repair of bacterial DNA
• Plasma concentration and elimination half-life information

Dosage & Administration

• Recommended dosage for adults and children (1 year of age and older)
• Safety and effectiveness in pediatric and geriatric use
• Pediatric use demonstrated in controlled clinical trials

Interaction

• No specific information found, topical ophthalmic use only

Contraindications

• Hypersensitivity to the active ingredient or any component

Side Effects

• Frequent ocular adverse event: conjunctival redness
• Other reported adverse events: blurred vision, eye pain, eye irritation, eye pruritus, headache

Pregnancy & Lactation

• Pregnancy Category C
• No adequate and well-controlled studies in pregnant women
• Presumed excretion in human milk, caution in nursing mothers

Precautions & Warnings

• For topical ophthalmic use only
• Not for injection subconjunctivally or into the anterior chamber of the eye
• Prolonged use may result in overgrowth of non-susceptible organisms
• Discontinue use if superinfection occurs, institute alternative therapy
• Instructions to prevent contamination, not wear contact lenses, and shake well before use

Therapeutic Class

• Ophthalmic antibacterial drugs

Storage Conditions

• Store at room temperature
• Protect from light and moisture
• Desirable shelf life after opening: one month

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