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Safety profile of cefixime.

F P Tally¹, R E Desjardins, E F McCarthy

¹Medical Research Division, American Cyanamid Company, Lederle Laboratories, Pearl River, NY 10965.

The Pediatric Infectious Disease Journal

|October 1, 1987

Summary

Cefixime demonstrates favorable clinical and laboratory safety in adults and children for various infections. Adverse events and laboratory abnormalities were comparable to other beta-lactam antibiotics, with similar safety profiles for once or twice-daily dosing.

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Area of Science:

Pharmacology
Clinical Microbiology
Infectious Diseases

Background:

Cefixime is a third-generation cephalosporin antibiotic.
Its safety profile requires thorough evaluation across different patient populations and dosing regimens.
Understanding safety is crucial for effective antimicrobial therapy.

Purpose of the Study:

To review the clinical and laboratory safety of cefixime.
To assess safety in adults and children with urinary tract and respiratory tract infections.
To compare safety based on daily versus twice-daily dosing.

Main Methods:

Analysis of safety data from 1575 adults and 615 children.
Inclusion of patients with urinary tract and respiratory tract infections.

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Review of clinical adverse events and laboratory abnormalities.

Main Results:

Adverse clinical experiences and laboratory abnormalities were similar to other beta-lactam agents.
Gastrointestinal side effects were the most common, independent of dosage frequency.
Drug hypersensitivity and serious abnormalities were infrequently reported.

Conclusions:

Cefixime exhibits a favorable safety profile in both adult and pediatric populations.
Safety is consistent regardless of whether cefixime is administered once or twice daily.
The drug is a safe option for treating indicated infections.