BRIEF SUMMARY OF PRESCRIBING INFORMATION For additional information refer to the full prescribing information


DESCRIPTION CIPRODEX® (ciprofloxacin 0.3% and dexa- methasone 0.1%) Sterile Otic Suspension contains the synthetic broad-spectrum antibacterial agent, ciprofloxacin hydrochlo- ride, combined with the anti-inflammatory corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of CIPRODEX® Otic contains ciprofloxacin hy- drochloride (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodi- um, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.


CLINICAL PHARMACOLOGY Microbiology: Cross-resistance has been observed between ciprofloxacin and other fluoroquinolones. There is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides.


INDICATIONS AND USAGE CIPRODEX® Otic is indicated for the treat- ment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:


Acute Otitis Media in pediatric patients (age 6 months and older) with tympanos- tomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.


Acute Otitis Externa in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.


CONTRAINDICATIONS CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal including herpes simplex infections.


WARNINGS FOR OTIC USE ONLY (This product is not approved for ophthalmic use.)


NOT FOR INJECTION


CIPRODEX® Otic should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment.


PRECAUTIONS General: As with other antibacterial preparations, use of this product may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.


The systemic administration of quinolones, including ciprofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.


Guinea pigs dosed in the middle ear with CIPRODEX® Otic for one month exhibited no drug-related structural or functional chang- es of the cochlear hair cells and no lesions in the ossicles. CIPRODEX® Otic was also shown to lack dermal sensitizing potential in the guinea pig when tested according to the method of Buehler.


No signs of local irritation were found when CIPRODEX® Otic was applied topically in the rabbit eye.


Information for Patients: For otic use only. (This product is not approved for use in the eye.) Warm the bottle in your hand for one to two minutes prior to use and shake well immediately before using. Avoid contaminating the tip with material from the ear, fingers, or other sources. Protect from light. If rash or allergic reaction occurs, discontinue use immediately and contact your physician. It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve. Discard unused portion after therapy is completed.


Acute Otitis Media in pediatric patients with tympanostomy tubes: Prior to administration of CIPRODEX® Otic in patients (6 months and older) with acute otitis media through tympanostomy tubes, the sus- pension should be warmed by holding the bottle in the hand for one or two minutes to


avoid dizziness which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION).


Acute Otitis Externa: Prior to administra- tion of CIPRODEX® Otic in patients with acute otitis externa, the suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION).


Drug Interactions: Specific drug interac- tion studies have not been conducted with CIPRODEX® Otic.


Carcinogenesis, Mutagenesis, Impair- ment of Fertility: Longterm carcinoge- nicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/ kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long term studies of CIPRODEX® Otic have been performed to evaluate carcinogenic potential.


Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below:


Salmonella/Microsome Test (Negative), E. coli DNA Repair Assay (Negative), Mouse Lymphoma Cell Forward Mutation Assay (Positive), Chinese Hamster V79 Cell HGPRT Test (Negative), Syrian Hamster Embryo Cell Transformation Assay (Negative), Saccharomyces cerevisiae Point Mutation Assay (Negative), Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative), Rat Hepatocyte DNA Repair Assay (Positive).


Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:


Rat Hepatocyte DNA Repair Assay, Micronucleus Test (Mice), Dominant Lethal Test (Mice).


Fertility studies performed in rats at oral


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