Otoflox Ear Drops

Ofloxacin

Otoflox

Indicated for otitis media and oitis externa caused by susceptible organisms.

Product Name

Otoflox

3mg/mL (0.3%) Sterile Otic Drops

Antibacterial

Generic Name

Ofloxacin

Various external otic infections caused by Gram-positive and Gram-negative bacteria are susceptible to Ofloxacin Otic Solution.

Pharmacokinetics

Studies have shown that a single administration of 10 drops of ofloxacin 0.3% otic solution in adult patients with otic infections yielded serm ofloxacin concentrations of ≤0.017 ug/mL and ≤0.007 ug/mL after 30 minutes 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 30 minutes after every administration.

In pediatric patients, serum ofloxacin concentration after single administration of 5 drops of 0.3% of ofloxacin otic solution were 0.0007 after 30 minutes and 0.013 ug/mL after 120 minutes.

Indications

Indicated for the treatment of external otic infections caused by Staphylococcus spp., Streptococcis spp., Enterococcus spp., Corynebasterium spp., and gram-negative bacteria like Paeruginosa, H. influenza, E. coli, Citrobacter spp., Klebisiella spp. Enterobacter spp., Providencia spp., S. Marascens, Proetus spp., Acinetobacter spp., Pseudomonas spp., A calcoceticus and Alcaligenes spp. and anaerobes.

Administration and Dosage

Tilt head upwards to allow infected otic to face up and still 1-2 drops of ofloxacin otic solution twice daily for 7 to a maximum of 14 days, morning and evening into the affected otic. Prevent the tip of the container from touching the otic. Keep face tilted up to 5 minutes and remove excess solution with clean cotton. Or as prescribed by the physician.

Direction For Use

To open turn cap clockwise until cap is removed. Tilt bottle over affected area and squeeze to allow drops to get into affected ear until 1-2 drops come out.

Close cap tightly after instillation.

Precautions and Contraindications:

1. Use no longer than 14 days.

2. Refrain from using in patients with a history of hypersensitivity to any of the components in this medication.

3. Discontinue use if adverse reaction appears.

Caution

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

Store are temperatures not exceeding 30 °C.

Keep container tightly closed.

AVAILABILITY: in 7.5 mL otic bottle.

Address

SENSOMED PHILIPPINES, INC.
Unit 1508, 1404 Orient Square Bldg., F. Ortigas Jr. Rd., Ortigas Center, Pasig City, Philippines

Telephone
(+632) 635-4917/ 635-5169

Telefax
(+632) 635-5170