Ofloxacin 0.3% E/E drops

Indications

Ofloxacin 0.3% E/E drops is used for: Bacterial Conjunctivitis, Otic infections, Bacterial corneal ulcer

Adult Dose

Ophthalmic Bacterial Conjunctivitis ; Keratoconjunctivitis Adult: Instill 1-2 drops in the affected eye(s) every 2-4 hr for the 1st 2 days, then 4 times daily. Max duration: 10 days. Corneal Ulcer Days 1-2: 1-2 drops q30min while awake Days 3-7: 1-2 drops q1hr while awake Days 7-9: 1-2 drops 4 times daily until clinical cure Otic/Aural Chronic Suppurative Otitis Media With Perforated Tympanic Membranes Adult: Instill 10 drops into the canal of the affected ear(s) bid for 14 days. Lie w/ the affected ear upwards for 5 min; pump the targus of the ear 4 times by pushing inward to facilitate penetration of the drops into the ear. Otitis externa Adult: Instill 10 drops into the canal of the affected ear(s) once daily for 7 days. Lie w/ the affected ear upwards for 5 min to facilitate penetration into the ear.

Child Dose

Ophthalmic Bacterial Conjunctivitis ; Keratoconjunctivitis Child>1 year: Instill 1-2 drops in the affected eye(s) every 2-4 hr for the 1st 2 days, then 4 times daily. Max duration: 10 days. Corneal Ulcer Child >1 year Days 1-2: 1-2 drops q30min while awake Days 3-7: 1-2 drops q1hr while awake Days 7-9: 1-2 drops 4 times daily until clinical cure Otic/Aural Chronic Suppurative Otitis Media With Perforated Tympanic Membranes Child >12 years: Instill 10 drops into the canal of the affected ear(s) bid for 14 days. Lie w/ the affected ear upwards for 5 min; pump the targus of the ear 4 times by pushing inward to facilitate penetration of the drops into the ear. Otitis externa Child >13 years: Instill 10 drops into the canal of the affected ear(s) once daily for 7 days. Lie w/ the affected ear upwards for 5 min to facilitate penetration into the ear. Child: 6 m-13 yr: Instill 5 drops into the canal of the affected ear(s) once daily for 7 days;

Renal Dose

Administration

Contra Indications

Patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

Precautions

As with other anti-infective preparations, prolonged use may result in over-growth of nonsusceptible organisms, including fungi. If the infection is not improved after one week, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor. The systemic administration of quinolones, including ofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.

Pregnancy-Lactation

Interactions

Concomitant use of class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic agents may increase risk of QT interval prolongation. Decreased serum and urine concentrations w/ antacids containing Mg, Al or Ca. Additive antibacterial activity w/ aminoglycosides (e.g. amikacin, tobramycin). Corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation (e.g. seizures) w/ NSAIDs. Higher and prolonged serum theophylline concentrations and increased risk of theophylline-related adverse effects.

Adverse Effects

Side effects of Ofloxacin 0.3% E/E drops : Ophthalmic: Transient ocular burning or discomfort following instillation of the solution, Conjunctival hyperemia, Chemical conjunctivitis/keratitis, Foreign body sensation, Blurred vision, Periocular/facial edema, Eye pain, Photophobia, Pruritus, Stinging, Tearing, Dryness, Hemorrhagic conjunctivitis with palpebral edema (rare). Otic/Aural >10% Application site reaction (1-17%) 1-10% Taste perversion (7%), Pruritus (4%), Dizziness (1%), Earache (1%), Paresthesia (1%), Rash (1%), Vertigo (1%) <1% Otorrhagia, Tinnitus, Transient hearing loss, Tremor, Xerostomia, Diarrhea

Mechanism of Action

Ofloxacin is a fluoroquinolone which inhibits bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination. It has activity against a wide range of gram-negative and gram-positive microorganisms.