Generic Name: Ofloxacin
Trade Name: Dizoflox
Manufacturer: Ashford Pharmaceutical Laboratories, Inc.
Source of Supply: Vendiz Pharmaceuticals, Inc.
Pharmacologic Classification: Fluoroquinolone Ear Anti-infectives
Mechanism of Action: Ofloxacin has in vitro activity against a wide range of gram- negative and gram-positive microorganisms. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription.
Therapeutic Indication : Indicated for the treatment of external otic infections caused by Staphylococcus Spp., Streptococcus spp., Enterococcus spp., Corynebacterium spp., and Gram negative bacteria like P. aeruginosa, H. influenza, E. coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Providencia spp., S. marescens, Proteus spp., and anaerobes.
Dosage Forms & Strength: 3mg/mL (0.3%)
Pharmacokinetics: Studies have shown that a single administration of 10 drops of Oflocaxin 0.3% otic solution in adult patients with otic infections yielded serum ofloxacin concentrations of –<0.017 ug/mL and -<0.007 ug/mL after 30minutes and 1 hour respectively. Ten drops of 0.3% ofloxacin otic solution applied twice daily for 7 days showed a serum concentration of -<0.012 ug/mL 30minutes after every administration.
Dosage and Administration: Tilt head sidewards to allow infected otic to face up and instill 1-2 drops of Ofloxacin otic solution twice daily for 7 days for a maximum of 14 days, morning and evening into the affected otic. Prevent the tip of the container from touching the otic. Keep head tilted up to 5 minutes and remove excess solution with a clean cotton. Or as prescribed by the physician.
Adverse Reactions: Hypersensitivity reaction, otalgia, tinnitus & itchiness Contraindications: Hypersensitivity to Ofloxacin
Storage Condition: Store at temperature not exceeding 300 C.
