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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin and dexamethasone otic suspension. (5.1) Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. (5.2) 5.1 Hypersensitivity Reactions Ciprofloxacin and dexamethasone otic suspension 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. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal, or facial edema), airway obstruction, dyspnea, urticaria, and itching. 5.2 Potential for Microbial Overgrowth with Prolonged Use Prolonged use of ciprofloxacin and dexamethasone otic suspension may result in overgrowth of non-susceptible, bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy. 5.3 Continued or Recurrent Otorrhea 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.
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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2)] Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). (6) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phases II and III clinical trials, a total of 937 patients were treated with ciprofloxacin and dexamethasone otic suspension. This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE. The reported adverse reactions are listed below: Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes. Adverse Reactions Incidence (N = 400) Ear discomfort 3% Ear pain 2.3% Ear precipitate (residue) 0.5% Irritability 0.5% Taste Perversion 0.5% The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema. Acute Otitis Externa The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes. Adverse Reactions Incidence (N=537) Ear pruritus 1.5% Ear debris 0.6% Superimposed ear infection 0.6% Ear congestion 0.4% Ear pain 0.4% Erythema 0.4% The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling). 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ciprofloxacin and dexamethasone otic suspension. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include auricular swelling...