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warnings and cautions
5 WARNINGS AND PRECAUTIONS Potential for Microbial Overgrowth : OTIPRIO may result in overgrowth of non-susceptible bacteria and fungi. ( 5.1 ) 5.1 Potential for Microbial Overgrowth OTIPRIO may result in overgrowth of non-susceptible bacteria and fungi. If such infections occur, institute alternative therapy.
6 ADVERSE REACTIONS Otitis Media with Effusion : The most frequently occurring adverse reactions (with an incidence rate greater than 3%) were nasopharyngitis and irritability. ( 6.1 ) Acute Otitis Externa : The most frequently occurring adverse reactions (with an incidence rate of at least 2%) were: ear pruritus, headache, otitis media and ear discomfort. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ALK-Abelló, Inc. at 1-855-216-6497 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Otitis Media with Effusion In two randomized, sham-controlled Phase 3 clinical trials, 530 pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement were treated with OTIPRIO or sham administered intratympanically as a single dose (0.1 mL to each ear). The median age of the pediatric patients enrolled in the clinical trials was 1.5 years; 62% of patients were 6 months through 2 years of age and 38% of patients were greater than 2 years of age. Adverse reactions that occurred in at least 3% of OTIPRIO patients and at an incidence greater than sham are presented in Table 1. Table 1: Adverse Reactions in Phase 3 Otitis Media with Effusion Trials Adverse Reactions OTIPRIO (N=357) Sham (N=173) Nasopharyngitis 5% 4% Irritability 5% 3% Rhinorrhea 3% 2% Acute Otitis Externa In a single randomized, sham controlled Phase 3 clinical trial, 259 pediatric and adult patients with acute otitis externa were treated with OTIPRIO or sham administered by a healthcare professional to the external ear canal as a single dose (0.2 mL to each affected ear). The median age of the patients enrolled in the clinical trial was 34 years; 26% were pediatric patients (age 3 to 17 years), 65% were adults (age 18 to 64 years), and 8% were elderly patients (age 65 years and older). Adverse reactions that occurred in at least 2% of OTIPRIO patients and at an incidence greater than sham are presented in Table 2. Table 2: Adverse Reactions in Phase 3 Acute Otitis Externa Trial Adverse Reactions OTIPRIO (N=127) Sham (N=132) Ear Pruritus 2% 2% Headache 2% 1% Otitis Media 2% 1% Ear Discomfort 2% 0%