Cefoperazone adverse reactions

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cefoperazone
Cefobid® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Dosage and Administration
Compatibility and Stability
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

In clinical studies the following adverse effects were observed and were considered to be related to CEFOBID therapy or of uncertain etiology:

Hypersensitivity

As with all cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.

Hematology

As with other beta-lactam antibiotics, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins (1 in 20) or hematocrits (1 in 20) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia has occurred in 1 patient in 10.

Hepatic

Of 1285 patients treated with cefoperazone in clinical trials, one patient with a history of liver disease developed significantly elevated liver function enzymes during CEFOBID therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After CEFOBID therapy was discontinued, the patient's enzymes returned to pre -treatment levels and the symptomatology resolved. As with other antibiotics that achieve high bile levels, mild transient elevations of liver function enzymes have been observed in 5–10% of the patients receiving CEFOBID therapy. The relevance of these findings, which were not accompanied by overt signs or symptoms of hepatic dysfunction, has not been established.

Gastrointestinal

Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences have been mild or moderate in severity and self-limiting in nature. In all cases, these symptoms responded to symptomatic therapy or ceased when cefoperazone therapy was stopped. Nausea and vomiting have been reported rarely.

Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibiotic therapy (see WARNINGS).

Renal Function Tests

Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted.

Local Reactions

CEFOBID is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When CEFOBID is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site.


References

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c6c2ef3b-2c53-4737-9f7d-2d7e040c6e87