Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media

To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.

Inclusion Criteria:

• Male and female children between 6 months and 4 years of age
• Weight does not exceed 40 kg
• Clinical diagnosis is acute otitis media
• Have evidence of middle ear fluid
• At risk for persistent or recurrent otitis media
• Generally in good health

Exclusion Criteria:

• Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications
• Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
• Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
• Concomitant infection, that requires additional antimicrobial therapy
• Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response