Data from FDA - Curated by EPG Health - Last updated 19 December 2016
In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with Ciprofloxacin Otic Solution.
The most frequently
(6) To report SUSPECTED
2 DOSAGE AND ADMINISTRATION The contents of one single use container (deliverable volume: 0.25 mL) should be instilled into the
Wash hands before use.
This position should be maintained for at least 1 minute to
Repeat, if necessary, for the opposite ear.
Contents of one single use container should be instilled into the
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Reproduction studies have been performed in
In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal
After intravenous administration of doses up to 20 mg/kg,
Animal reproduction studies have not been conducted with Ciprofloxacin Otic Solution.
8.3 Nursing Mothers Ciprofloxacin is excreted in human milk with systemic use.
It is not known whether ciprofloxacin is excreted in human milk following otic use.
Because of the
8.4 Pediatric Use The
The efficacy of Ciprofloxacin Otic Solution in treating otitis externa in pediatric patients one year or older has been demonstrated in
8.5 Geriatric Use
|Date Last Revised||31-08-2012|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Store at 15ºC to 25ºC (59ºF to 77ºF). Discard used containers. Store unused containers in pouch to protect from light.|
|Marketing authorisation holder||Xspire Pharma|