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CEPTAZ®
(ceftazidime) Injection
L-arginine formulation

For Intravenous or Intramuscular Use

DESCRIPTION

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β (Z)]]. It has the following structure:

The empirical formula is C22H32N6O12S2, representing a molecular weight of 636.6.

CEPTAZ is a sterile, dry mixture of ceftazidime pentahydrate and L-arginine. The L-arginine is at a concentration of 349 mg/g of ceftazidime activity. CEPTAZ (ceftazidime) dissolves without the evolution of gas. The product contains no sodium ion. Solutions of CEPTAZ (ceftazidime) range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 7.5.

INDICATIONS

CEPTAZ (ceftazidime) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

Specimens for bacterial cultures should be obtained before therapy in order to isolate and identify causative organisms and to determine their susceptibility to ceftazidime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

CEPTAZ (ceftazidime) may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibiotics have been used.

CEPTAZ (ceftazidime) may also be used concomitantly with other antibiotics, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient (see Compatibility And Stability). When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibiotics should be followed. The dosage depends on the severity of the infection and the patient's condition.

DOSAGE AND ADMINISTRATION

Dosage: The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.

The guidelines for dosage of CEPTAZ (ceftazidime) are listed in Table 3. The following dosage schedule is recommended.

Table 3. Recommended Dosage Schedule

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.

Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR] < 50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of CEPTAZ (ceftazidime) may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 4.

Table 4. Recommended Maintenance Dosages of CEPTAZ (ceftazidime) in Renal Insufficiency NOTE: IF THE DOSE RECOMMENDED IN TABLE 3 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 4, THE LOWER DOSE SHOULD BE USED.