Celsus Ciprofloxacin Otic Solution

Celsus Ciprofloxacin Otic Solution

ciprofloxacin

Manufacturer:

EL Lab

Distributor:

Celsus
Full Prescribing Info
Contents
Ciprofloxacin.
Description
Each mL contains ciprofloxacin hydrochloride equivalent to 2 mg ciprofloxacin base with benzalkonium chloride 0.006% (m/v) as preservative.
A single 3-drop dose contains approximately 300 micrograms ciprofloxacin.
Action
Pharmacology: Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic with proven activity against bacteria causing bacterial otitis externa. In vitro susceptibility data for species where clinical efficacy has been demonstrated, include Enterobacteriaceae, Pseudomonas aeruginosa and Staphylococcus aureus. Sensitivity testing should be performed before treatment is initiated. Anaerobes are usually resistant. A single 3-drop dose of Ciprofloxacin otic drops delivers 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 micrograms) 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 micrograms/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.
Measurements after ototopical administration are not known to have been performed.
Indications/Uses
The treatment of acute bacterial otitis externa caused by organisms susceptible to the action of ciprofloxacin, such as Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae.
Dosage/Direction for Use
For children (age two and older) and adults, three drops of Ciprofloxacin otic drops should be instilled into the affected ear twice daily for seven days or as directed by the physician. 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.
Overdosage
There have been no reports of overdosage with Ciprofloxacin otic drops in humans.
Treatment should be symptomatic and supportive.
Contraindications
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. Ciprofloxacin otic drops is not indicated for the treatment of otitis media.
Warnings
Use in Pregnancy & Lactation: Caution should be exercised with the use of Ciprofloxacin otic drops in pregnant women and nursing mothers, since there is no experience on the safety of the drug in these patient groups.
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.
Use In Pregnancy & Lactation
Use in Pregnancy & Lactation: Caution should be exercised with the use of Ciprofloxacin otic drops in pregnant women and nursing mothers, since there is no experience on the safety of the drug in these patient groups.
Side Effects
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.
Drug Interactions
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.
Caution For Usage
Instructions for Use/Handling: Remove the closure and put the dropper assembly in place on the bottle. Ciprofloxacin otic drops is 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. Warm to room temperature prior to administration.
Discard unused portion after treatment is completed.
Incompatibilities: None known. However, Ciprofloxacin otic drops should not be mixed with other drugs.
Storage
Store below 30°C. Protect from direct sunlight.
When opened Ciprofloxacin otic drops is stable at temperatures below 30°C for 14 days.
ATC Classification
S02AA15 - ciprofloxacin ; Belongs to the class of antiinfectives used in the treatment of ear infections.
Presentation/Packing
Ear drops (sterile, slightly viscous white to off-white opaque suspension with a slightly acetous odour) 0.3% x 7.5 mL x 1's.
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