Ofloxacin

INDICATIONS AND USAGE

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 .

8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where: • there is resistance to other first-line antibiotics recommended for the infection; • other first-line antibiotics are contraindicated in an individual patient; • other first-line antibiotics have caused side effects requiring treatment to be stopped; • treatment with other first-line antibiotics has failed.

): - Uncomplicated acute cystitis - Acute pyelonephritis - Complicated urinary tract infections - Acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis - Community-acquired pneumonia - Gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoea - Non-gonococcal urethritis and cervicitis; - Complicated skin and soft tissue infections Consideration should be given to official guidance on the appropriate use of anti-bacterial agents.

OCUFLOX® (ofloxacin) is indicated for the treatment of conjunctivitis when caused by susceptible strains of the following bacteria: Gram Positive Bacteria • Staphylococcus aureus • Staphylococcus epidermidis • Streptococcus pneumoniae Gram Negative Bacteria • Haemophilus influenza To reduce the development of drug-resistant bacteria and maintain the effectiveness of OCUFLOX and other antibacterial drugs, OCUFLOX should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of OCUFLOX in pediatric patients has not been established. Therefore, Health Canada has not authorized an indication for pediatric use.

3 Pediatrics. 2 Geriatrics Geriatrics (> 65 years of age): No comparative data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.