CIPROBAY® HC OTIC DROPS
(and dosage form):
CIPROBAY® HC OTIC DROPS
Each mL contains ciprofloxacin hydrochloride equivalent to 2 mg ciprofloxacin base and 10 mg hydrocortisone, with benzyl alcohol 0.9% (m/v) as preservative.
A single 3-drop dose contains approximately 300 micrograms ciprofloxacin and 1.5 mg of hydrocortisone.
A 16.2 Aural preparations, ear drops.
Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic with proven activity against bacteria causing bacterial otitis externa. Hydrocortisone is a corticosteriod with a range of anti-inflammatory properties.
Ciprofloxacin acts by inhibiting bacterial DNA gyrase. In vitro susceptibility data for species where clinical efficacy has been demonstrated, include Enterobacteriaceae, Pseudomonas aeruginosa andStaphylococcus aureus. Sensitivity testing should be performed before treatment is initiated. Anaerobes are usually resistant. A single 3-drop dose of CiproBay®HC otic dropsdelivers approximately 300 micrograms of ciprofloxacin, giving local concentrations well in excess of the MICs for the pathogens associated with bacterial otitis externa.
Predicted ciprofloxacin serum concentrations after ototopic administration of a 0.2% ciprofloxacin formulation (total dose per application approximately 300 microgramms) would be below the existing assay detection limits (limit of quantification 5 micrograms/L). Even if full absorption of the topical dose were seen, peak ciprofloxacin concentrations of only approximately 3 microgramms/L would be expected at steady state, based on data for oral administration. Data shows that there were no measurable plasma concentrations of ciprofloxacin after ototopic administration of a 0.3% ciprofloxacin formulation to children with chronic suppurative otitis media.
Absorption of hydrocortisone after topical administration is generally low, and varies greatly with the site of administration. Measurements after ototopical administration are not known to have been performed.
The treatment of acute bacterial otitis externa caused by organisms susceptible to the action of ciprofloxacin, such as Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae.
Persons with a history of hypersensitivity to ciprofloxacin, any other quinolones or any of the components of this medication. Patients with known or suspected perforated tympanic membrane. CiproBay®HC otic dropsis not indicated for the treatment of otitis media.
Pregnancy and Lactation
Caution should be exercised with the use of CiproBay® HC otic dropsin pregnant women and nursing mothers, since there is no experience on the safety of the drug in these patient groups.
DOSAGE AND DIRECTIONS FOR USE
For children (age two and older) and adults, three drops of CiproBay®HC otic drops should be instilled into the affected ear twice daily for seven days. The bottle should be shaken well immediately before use.
The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for a minimum of 30 seconds to facilitate penetration of the drops into the external ear canal. Repeat, if necessary, for the opposite ear.
Instructions for use/handling
Remove the closure and put the dropper assembly in place on the bottle. CiproBay®HC otic dropsis a ready-to-use product when the dropper assembly is placed on the bottle. Avoid contaminating the dropper with material from the ear, fingers or other sources.
Shake well immediately before using.
Warm to room temperature prior to administration.
Discard unused portion after treatment is completed.
None known. However, CiproBay®HC otic drops should not be mixed with other drugs.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
The only reported adverse drug reactions with a frequency of between 0.1% and 1% were localised reactions such as hypesthesia, paresthesia, pruritis, rash and urticaria.
Special warnings and special precautions
Discontinue at the first appearance of a skin rash or any other signs of local or general hypersensitivity. Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.
None known for this formulation and route of administration.
Very rare cases of product residue in the ear canal with or without symptoms such as ear discomfort, hearing disorders and ear pain have been reported during post-marketing experience.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
There have been no reports of overdosage with CiproBay®HC otic drops in humans.
Treatment should be symptomatic and supportive.
Slightly viscous white to off-white opaque suspension with a slightly acetous odour.
Each trade package carton comprises a 10 mL glass bottle with a polypropylene closure, a wrapped dropper assembly, consisting of a polyethylene pipette, a polypropylene cap and a rubber bulb. At the time of dispensing, the dropper assembly replaces the polypropylene closure.
Store below 25°C. Do not refrigerate. Protect from direct sunlight. Keep out of reach of children. When opened and when the dropper assembly is in place, CiproBay®HC otic drops is stable at room temperature below 25°C for 14 days.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Alcon Laboratories (SA) (Pty) Ltd
261 Surrey Avenue
DATE OF PUBLICATION OF THIS PACKAGE INSERT
21 January 2002
® Registered trade mark of Bayer AG Germany.
Updated on this site: March 2003
Source: Pharmaceutical Industry
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