Each 1 mL contains Ofloxacin 3 mg.
Pharmacology: Pharmacodynamics: Antibacterial activity: Ofloxacin shows a broad spectrum of antibacterial activity against gram-positive and gram-negative bacteria. It is active against bacteria isolated from otitis media and otitis externa, including Staphylococcus sp., Streptococcus sp., Proteus sp., Pseudomonas aeruginosa and Haemophilus influenzae.
Mechanism of action: Ofloxacin is considered to specifically affect DNA gyrase and inhibit DNA synthesis in microorganism. Its antibacterial activity is bactericidal, and cause bacteriolysis at MIC.
Pharmacokinetics: Blood concentration: When 0.3% ofloxacin solution was instilled into the middle ear at 10 drops per administration twice a day for 7 days (total of 14 times) in adult patients, the serum concentration in 30 minutes after administration ranged from 0.009 to 0.012 μg/mL, showing a low value.
Distribution: When 0.3% ofloxacin solution was instilled into the middle ear at 10 drops per administration twice a day for 10 days (total of 19 times) in adult patients, the concentration in the mucosa of the middle ear in 90 minutes after administration was 20 μg/g, and when a single administration of 0.1% ofloxacin solution at 10 drops was instilled, the concentration in the otorrhea in 30 minutes after administration ranged from 107 to 610 μg/mL, showing a high value.
The following infections caused by ofloxacin-susceptible, Staphylococcus sp., Streptococcus sp., Proteus sp., Pseudomonas aeruginosa, and Haemophilus influenzae, Otitis media, Otitis externa.
Adults: 6-10 drops is usually applied into the ear twice a day.
The eardrop should be allowed to maintain in the ear for 10 minutes.
The dosage may be adjusted depending on the symptoms.
Children: Dosage may be decreased.
Patient with a history of hypersensitivity to ofloxacin.
General precaution: As a general rule, the duration of treatment with this drug should be 4 weeks as a standard. Continuing administration after 4 weeks should not be desultory and administer the drug with caution.
If hypertensive symptoms are observed discontinue the medication.
Earache may occur infrequently.
Substituted microbism may occur infrequently.
Coadministration of the oral administration of ofloxacin with non-steroidal and anti-inflammatory drugs of phenylacetic/propionic acid derivatives may possibly cause convulsion. However, when this drug was topically instilled and allow to maintain in the ear, the peak blood concentration was low, the value being 1/100 when compared to that of oral administration. Therefore, it is presumed that there is practically no possibility that coadministration with these anti-inflammatory analgesics may induce convulsion.
Route of administration: Use only for instillation.
Method of therapy: Topical therapy by the instillation of this agent is generally applicable when inflammation is localized in the mucosa of the middle ear in patients with tympanitis. When inflammation is extended into the region around the tympanum systemic therapy with oral agents should be considered in combination with topical therapy.
Caution in administration: If the solution is cold, dizziness may occur. Thus use the drug at a temperature as similar to that of the body temperature as possible.
S02AA16 - ofloxacin ; Belongs to the class of antiinfectives used in the treatment of ear infections.
Ear drops 0.3% x 5 mL x 1's, 10's.