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[Local irritancy study of cefpirome sulfate]
The Journal of Toxicological Sciences
|November 1, 1990
Summary
Cefpirome sulfate (CPR) demonstrated low local irritancy in rabbit safety studies, with minimal effects on skin, eyes, and muscle tissue. However, CPR induced hemolysis in human blood, indicating a potential safety concern.
Area of Science:
- Pharmacology
- Toxicology
- Dermatology
Background:
- Cefpirome sulfate (CPR) is an antibiotic requiring thorough safety evaluation.
- Local tolerability is a critical aspect of drug safety assessment.
Purpose of the Study:
- To evaluate the local irritancy of cefpirome sulfate (CPR) via various administration routes in rabbits.
- To assess the hemolytic potential of CPR using human blood.
Main Methods:
- Intracutaneous, conjunctival sac, intramuscular (single and repeated), and intravenous injections in rabbits.
- Macroscopic and microscopic examination of tissue responses.
- Hemolysis testing on human blood using macroscopic and spectrophotometric methods.
Main Results:
- CPR exhibited low local irritancy upon intracutaneous injection, conjunctival sac application, and intramuscular administration, often comparable to or less severe than control solutions.
- Repeated intravenous administration showed thrombus formation and organized thrombus in rabbits.
- CPR induced hemolysis in human blood samples.
Conclusions:
- Cefpirome sulfate (CPR) demonstrates a favorable local tolerability profile for most administration routes, with mild to moderate effects.
- The observed thrombogenesis with intravenous CPR warrants further investigation.
- The hemolytic potential of CPR necessitates careful consideration during clinical use.