The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved December 1997

Specific Treatments:

bacteria causing pulmonary, throat, and skin infections

General Information

Omnicef (cefdinir), a broad spectrum antibiotic for adult and pediatric use, was cleared for marketing by the FDA. In adults and adolescents, Omnicef is indicated for the treatment of community acquired pneumonia, acute exacerbation of chronic bronchitis, acute bacterial sinusitis, pharyngitis and tonsilitis, and uncomplicated skin and skin structure infections. In children, Omnicef is also indicated for the treatment of acute bacterial otitis media (middle ear infections)

The adult formulation of Omnicef is a 300 mg capsule. The pediatric formulation is a pleasant-tasting strawberry flavored suspension.

Clinical Results

In an extensive controlled clinical trial program involving over 13,000 patients (9,600 adults and 3,400 children) over a four-year period, Omnicef capsules and powder for oral suspension have proven to be effective, well-tolerated therapies for a wide variety of community infections.

Side Effects

Omnicef has proven to be well tolerated in clinical trials. Most side effects involved the gastrointestinal tract. Omnicef should not be used in patients with a known allergy to the cephalosporin class of antibiotics.