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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity : Discontinue use at the first appearance of a skin rash or any other sign of hypersensitivity. ( 5.1 ) Potential for Microbial Overgrowth: Prolonged use may result in the overgrowth of non-susceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy. ( 5.2 ) 5.1 Hypersensitivity Reactions Ciprofloxacin and Fluocinolone Acetonide Otic Solution 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. Serious acute hypersensitivity reactions may require immediate emergency treatment. 5.2 Potential for Microbial Overgrowth with Prolonged Use Prolonged use of Ciprofloxacin and Fluocinolone Acetonide Otic Solution 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 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] The most common adverse reactions that occurred in ≥1 patient were otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling and balance disorder ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals at 1-877-495-6856 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 224 patients with AOMT were treated with Ciprofloxacin and Fluocinolone Acetonide Otic Solution for a median duration of 7 days. All the patients received at least one dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution. There were 220 patients who received at least one dose of ciprofloxacin (CIPRO) and 213 patients received at least one dose of fluocinolone acetonide (FLUO). The most common adverse reactions that occurred in 1 or more patients are as follows: Table 1: Selected Adverse Reactions that Occurred in 1 or more Patients in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution Group Adverse Reactions Selected adverse reactions that occurred in ≥ 1 patient in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution group derived from all reported adverse events that could be related to the study drug or the drug class. Number (%) of Patients Ciprofloxacin and Fluocinolone Acetonide Otic Solution N=224 CIPRO N=220 FLUO N=213 Otorrhea 12 (5.4%) 9 (4.1%) 12 (5.6%) Excessive granulation tissue 3 (1.3%) 0 (0.0%) 2 (0.9%) Ear infection 2 (0.9%) 3 (1.4%) 1 (0.5%) Ear pruritus 2 (0.9%) 1 (0.5%) 1 (0.5%) Tympanic membrane disorder 2 (0.9%) 0 (0.0%) 0 (0.0%) Auricular swelling 1 (0.4%) 1 (0.5%) 0 (0.0%) Balance disorder 1 (0.4%) 0 (0.0%) 0 (0.0%) 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ciprofloxacin and fluocinolone acetonide otic solution, 0.3% / 0.025% outside the US. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders: allergic reaction. Infections and infestations: candidiasis. Nervous system disorders: dysgeusia, paresthesia (tingling in ears), dizziness, headache. Ear and labyrinth disorders: ear discomfort, hypoacusis, tinnitus, ear congestion. Vascular disorders: flushing. Skin and subcutaneous tissue disorders: skin exfoliation. Injury, poisoning and procedural complications: device occlusion (tympanostomy tube obstruction).
adverse reactions table
<table width="75%"><caption>Table 1: Selected Adverse Reactions that Occurred in 1 or more Patients in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution Group</caption><col width="40%" align="left" valign="top"/><col width="20%" align="center" valign="top"/><col width="20%" align="center" valign="top"/><col width="20%" align="center" valign="top"/><thead><tr><th rowspan="2" styleCode="Lrule Rrule">Adverse Reactions <footnote ID="K629">Selected adverse reactions that occurred in ≥ 1 patient in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution group derived from all reported adverse events that could be related to the study drug or the drug class.</footnote></th><th colspan="3" styleCode="Rrule Botrule">Number (%) of Patients</th></tr><tr><th align="center" styleCode="Lrule Rrule">Ciprofloxacin and Fluocinolone Acetonide Otic Solution N=224 </th><th styleCode="Rrule" valign="middle">CIPRO N=220 </th><th styleCode="Rrule" valign="middle">FLUO N=213 </th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Otorrhea</td><td styleCode="Rrule">12 (5.4%)</td><td styleCode="Rrule">9 (4.1%)</td><td styleCode="Rrule">12 (5.6%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Excessive granulation tissue</td><td styleCode="Rrule">3 (1.3%)</td><td styleCode="Rrule">0 (0.0%)</td><td styleCode="Rrule">2 (0.9%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Ear infection</td><td styleCode="Rrule">2 (0.9%)</td><td styleCode="Rrule">3 (1.4%)</td><td styleCode="Rrule">1 (0.5%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Ear pruritus</td><td styleCode="Rrule">2 (0.9%)</td><td styleCode="Rrule">1 (0.5%)</td><td styleCode="Rrule">1 (0.5%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Tympanic membrane disorder</td><td styleCode="Rrule">2 (0.9%)</td><td styleCode="Rrule">0 (0.0%)</td><td styleCode="Rrule">0 (0.0%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Auricular swelling</td><td styleCode="Rrule">1 (0.4%)</td><td styleCode="Rrule">1 (0.5%)</td><td styleCode="Rrule">0 (0.0%)</td></tr><tr><td styleCode="Lrule Rrule">Balance disorder</td><td styleCode="Rrule">1 (0.4%)</td><td styleCode="Rrule">0 (0.0%)</td><td styleCode="Rrule">0 (0.0%)</td></tr></tbody></table>