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[Acute toxicity study of cefodizime sodium]
1Pharma Research and Development Division, Hoechst Japan Limited, Saitama.
The Journal of Toxicological Sciences
|June 1, 1988
Summary
Cefodizime sodium (THR-221) exhibits low acute toxicity across mice, rats, and dogs, with high LD50 values indicating a good safety profile. Observed transient effects were generally mild and dose-dependent.
Area of Science:
- Pharmacology
- Toxicology
- Drug Safety
Context:
- Cefodizime sodium (THR-221) is an antibiotic requiring thorough safety evaluation.
- Acute toxicity studies are crucial for determining safe dosage ranges and potential adverse effects of new drugs.
Purpose:
- To determine the acute toxicity and LD50 values of cefodizime sodium in various animal models.
- To identify potential target organs and adverse reactions associated with cefodizime sodium administration.
Summary:
- Acute toxicity of cefodizime sodium was assessed in mice, rats (including young), and dogs via intravenous, intraperitoneal, subcutaneous, oral, and intramuscular routes.
- LD50 values were determined, generally showing high tolerance. Observed clinical signs and gross/microscopic findings were mostly transient and route-dependent.
- Hematological and blood chemistry changes in dogs were transient, indicating a favorable safety profile for cefodizime sodium.
Impact:
- Provides essential data for the safe clinical use of cefodizime sodium.
- Contributes to the understanding of cephalosporin antibiotic toxicology.
- Informs regulatory submissions and risk assessments for cefodizime sodium.