CIPROBAY HC OTIC SUSPENSION

4.1 Therapeutic indications

CIPROBAY HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Proteus mirabilis.

4.3 Contraindications

• Hypersensitivity to the active substance(s), to other quinolones or to any of the excipients.
• Viral or fungal infections of the external ear canal including varicella and herpes simplex infections.
• Known or suspected perforation of the eardrum

4.2 Posology and method of administration

SHAKE WELL IMMEDIATELY BEFORE USING.

For children (age 1 year and older) and adults, 3 drops of the suspension should be instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for 1–2 minutes to avoid the dizziness which may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled.

This position should be maintained for 30–60 seconds to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.

Pediatric use: The safety and efficacy of CIPROBAY HC OTIC have been established in pediatric patients 2 years and older (131 patients) in adequate and well-controlled clinical trials. Although no data are available on patients less than age 2 years, there are no known safety concerns or differences in the disease process in this population which would preclude use of this product in patients one year and older.