Floxin Otic Singles

INDICATIONS

FLOXIN® Otic SINGLES™ (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.

Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.

DOSAGE AND ADMINISTRATION

Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is:

For pediatric patients (from 6 months to 13 years old): instill the contents of 1 single-dispensing container into the affected ear once daily for seven days.

For patients 13 years and older: instill the contents of 2 single-dispensing containers into the affected ear once daily for seven days.

The solution should be warmed by holding the container 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 medication should be instilled. This position should be maintained for five minutes to facilitate penetration of the medication into the ear canal. Repeat, if necessary, for the opposite ear.

Acute Otitis Media in pediatric patients with ympanostomy 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:

Instill the contents of 1 single-dispensing container into the affected ear twice daily for ten days. The solution should be warmed by holding the container 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 medication should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the medication into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

Chronic Suppurative Otitis Media with perforated tympanic membranes: The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:

Instill the contents of 2 single-dispensing containers into the affected ear twice daily for fourteen days. The solution should be warmed by holding the container 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, before instilling the medication. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

HOW SUPPLIED

FLOXIN® Otic SINGLES™ (ofloxacin otic) solution 0.3% is supplied in plastic singledispensing containers, 0.25 mL each, packaged 2 per foil pouch.

NDC 63395-101-01 FLOXIN® Otic SINGLES™ (ofloxacin otic solution) , 1 foil pouch containing 2 singledispensing containers, per Physician Sample box.

NDC 63395-101-11 FLOXIN® Otic SINGLES™ (ofloxacin otic solution) , 10 foil pouches each containing 2 single-dispensing containers (5 mL net volume), per carton.

Storage Conditions: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Protect from light.

Daiichi Pharmaceutical Corporation., Montvale, NJ 07645., Revised: April 2005. FDA revision date: 5/4/2005

Last reviewed on RxList: 1/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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