Ofloxacin otic

Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli , Pseudomonas aeruginosa and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa and Staphylococcus aureus. …

• Otitis Externa: The recommended dosage regimen
• For the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days
• For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days
• The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution
• The patient should lie with the affected ear upward, and then the drops should be instilled
• This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal
• Repeat, if necessary, for the opposite ear
• Acute Otitis Media
• In pediatric patients with tympanostomy tubes: The recommended dosage regimen
• For the treatment of acute otitis media
• In pediatric patients (from 1 to 12 years old) with tympanostomy tubes is: Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days
• The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution
• The patient should lie with the affected ear upward, and then the drops should be instilled
• The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear

• Safety and efficacy have been demonstrated
• In pediatric patients of the following ages for the listed indications: ■ six months and older: otitis externa with intact tympanic membranes ■ one year and older: acute otitis media with tympanostomy tubes ■ twelve years and older: chronic suppurative otitis media with perforated tympanic membranes Safety and efficacy
• In pediatric patients below these ages have not been established. …

• Avoid contaminating the applicator tip with material from the fingers or other sources
• This precaution is necessary if the sterility of the drops is to be preserved
• Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose
• Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction
• Otitis Externa: Prior to administration of ofloxacin otic, the solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. …

Ofloxacin Otic Solution 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

Specific drug interaction studies have not been conducted with Ofloxacin Otic Solution 0.3%.

NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to ofloxacin is suspected, stop the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation, should be administered as clinically indicated.

Subjects with Otitis Externa In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with Ofloxacin Otic Solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). …

Pregnancy Teratogenic effects: Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day. These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.