CIPROBAY HC OTIC SUSPENSION

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

SOLUTION

**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.