Cefpirome warnings and precautions

Cefpirome
CEFROM® Package Insert
Composition
Properties
Indications
Microbiology
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Dosage and Administration
How Supplied

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Warnings and Precautions

The Ocurrence of any allergic reaction necessitates discontinuation of treatment. The prescription of cephalosporins requires prior interview, as cross-allergy between penicillins and cephalosporins is present in 5 to 10% of cases. Cephalosporins must be used with extreme caution in penicillin sensiti~ patients.

The use of cephalosporins is strictly prohibited in subjects wilh a history of immediate allergy to cephalosporins. In case of doubt, the presence of the doctor is essential at the time of first administration in order to treat a possible anaphylactic (sudden and severe allergic) reactton which may progress to life-threatening shock and require emergency treatment.

It is advisable to monitor renal funclton during treatment with combinations of cefpirome and diuretics of lhe furosemide or ethacrynic acid type and potenlially nephrotoxic drugs such as certain antibtotics (aminogtyrosides in partirular). In cases of impaired renal function, adjust the dosage according to the creatinine clearance (see under "Dosage and administration").

As with other beta lactam antibiotic granulocytopenia and, more rarely, agranulocylosis ( a potentially life·threateoing depletion of certain white blood cells) may develop, parlicularly if Cefrom is given over longer periods.

The blood cell count should therefore be monitored for courses of treatment lasting for more than 10 days.

Severe and petsistent diarrhea may occur with broad spectrum antibiotics during treatment or in the weeks following discontinuation. These episodes may be symptomatic of pseudomembranous colitis (in most cases, due to Clostridium difficile). This event, which is rare wilh cephalosporins, may be life threatening.

Even if pseudomembranous colitis is only suspected, administration of Cefrom must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician.

Drugs that inihibit intestinal mobility must not be taken in such cases.

Insufficient clinical experience has been gained with Cefrom in children.

The safety of cefpirome has not yet been established in pregnant women. Cefrom musl not be administered during pregnancy. Studies in several animal species have shown no teratogenic or fetotoxic action.

The safety of cefpirome has not yet been established in lactating women. Therefore, breast-feeding should be discontinued during treatment with Cefrom.