Safety Information

DRUG INTERACTIONS

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibiotics or potent diuretics such as frusemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycosidic antibiotics. Nephrotoxicity and ototoxicity were not noted when Ceftazidime was given alone in clinical trials. Serum and urine specimens for examination should be collected during therapy Serum calcium, magnesium, and sodium should be monitored.

WARNINGS

FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, BEFORE THERAPY WITH Tobracef (CEFTAZIDIME AND TOBRAMYCIN) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME AND TOBRAMYCIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFTAZIDIME-TOBRAMYCIN COMBINATION OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IVAS CLINICALLY INDICATED.

SIDE EFFECTS

The adverse effects from clinical trials were considered to be either related to Tobracef therapy or were of uncertain etiology. The most common were local reactions (phlebitis and inflammation at the site of injection) following IV injection. Allergic and gastrointestinal reactions are also reported in few cases. No disulfiram like reactions were reported. Tobramycin and gentamicin sulfates closely parallel each other in regard to ototoxic potential. In some of the clinical studies and in the animal studies, Tobramycin caused nephrotoxicity.

Pregnancy Administration is contradicted in pregnancy.

Nursing Mothers Tobracef (Ceftazidime and Tobramycin ) is excreted in human milk in low concentrations. Therefore, caution should be exercised when the combination is administered to a nursing woman.