During clinical investigations, adult patients were treated with doripenem (500 mg administered over 1 hour q8h) in the three comparative phase III clinical studies conducted by the innovator; in some patients, parenteral therapy was followed by a switch to an oral antimicrobial. The median age of patients treated with doripenem was 54 years (range 18-90) in the comparative complicated urinary tract infection (cUTI) study and 46 years (range 18-94) in the pooled comparative complicated intra-abdominal infection (cIAI) studies. There was a female predominance (62%) in the comparative cUTI study and male predominance (63%) in the pooled cIAI studies. The patients treated with doripenem were predominantly Caucasian (77%) in the three pooled phase III studies.
The most common adverse reaction (≥5%) observed in the doripenem clinical trial were headache, nausea, diarrhea, rash and phlebitis. During clinical trials, adverse drug reactions that led to doripenem discontinuation were nausea (0.2%), vulvomycotic infection (0.1%) and rash (0.1%).
Adverse reactions due to doripenem 500 mg q8h that occurred at a rate ≥1% in either indication are listed in Table 4. Hypersensitivity reactions related to intravenous study drug and C. difficile colitis occurred at a rate of less than 1% in the controlled phase III clinical trial. (See Table 4.)
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Postmarketing experience: The following treatment-emergent adverse events (known to occur with β-lactams including carbapenems) have been reported voluntarily during post approval use of doripenem. They are included due to their seriousness, although it is not possible to estimate their frequency and casualty has not been established: Anaphylaxis; Stevens-Johnson Syndrome; Toxic epidermal necrolysis; Interstitial pneumonia, Seizure.