TAZICEF

TAZICEF- ceftazidime injection, powder, for solution
Hospira, Inc.

For Intravenous Use in ADD-Vantage® Vials

Rx only

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tazicef (ceftazidime) and other antibacterial drugs, Tazicef (ceftazidime) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug 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:

Chemical Structure
(click image for full-size original)

The molecular formula is C22 H32 N6 O12 S2 , representing a molecular weight of 636.6.

Tazicef (ceftazidime for injection, USP) is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 51 mg (2.2 mEq)/g of ceftazidime activity.

Tazicef in sterile crystalline form is supplied in ADD-Vantage® vials equivalent to 1 g or 2 g of anhydrous ceftazidime.

Solutions of Tazicef 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.

CLINICAL PHARMACOLOGY

After IV administration of 500-mg and 1-g doses of ceftazidime over 5 minutes to normal adult male volunteers, mean peak serum concentrations of 45 and 90 mcg/mL, respectively, were achieved. After IV infusion of 500-mg, 1-g, and 2-g doses of ceftazidime over 20 to 30 minutes to normal adult male volunteers, mean peak serum concentrations of 42, 69, and 170 mcg/mL, respectively, were achieved. The average serum concentrations following IV infusion of 500-mg, 1-g, and 2-g doses to these volunteers over an 8-hour interval are given in Table 1.

Table 1. Average Serum Concentrations of Ceftazidime
Ceftazidime Serum Concentrations (mcg/mL)
IV Dose 0.5 hr 1 hr 2 hr 4 hr 8 hr
500 mg 42 25 12 6 2
1 g 60 39 23 11 3
2 g 129 75 42 13 5

The absorption and elimination of ceftazidime were directly proportional to the size of the dose. The half-life following IV administration was approximately 1.9 hours. Less than 10% of ceftazidime was protein bound. The degree of protein binding was independent of concentration.

There was no evidence of accumulation of ceftazidime in the serum in individuals with normal renal function following multiple IV doses of 1 and 2 g every 8 hours for 10 days.

Following intramuscular (IM) administration of 500-mg and 1-g doses of ceftazidime to normal adult volunteers, the mean peak serum concentrations were 17 and 39 mcg/mL, respectively, at approximately 1 hour. Serum concentrations remained above 4 mcg/mL for 6 and 8 hours after the IM administration of 500-mg and 1-g doses, respectively. The half-life of ceftazidime in these volunteers was approximately 2 hours.

The presence of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime in individuals administered 2 g intravenously every 8 hours for 5 days. Therefore, a dosage adjustment from the normal recommended dosage is not required for patients with hepatic dysfunction, provided renal function is not impaired.

Approximately 80% to 90% of an IM or IV dose of ceftazidime is excreted unchanged by the kidneys over a 24-hour period. After the IV administration of single 500-mg or 1-g doses, approximately 50% of the dose appeared in the urine in the first 2 hours. An additional 20% was excreted between 2 and 4 hours after dosing, and approximately another 12% of the dose appeared in the urine between 4 and 8 hours later. The elimination of ceftazidime by the kidneys resulted in high therapeutic concentrations in the urine.

The mean renal clearance of ceftazidime was approximately 100 mL/min. The calculated plasma clearance of approximately 115 mL/min indicated nearly complete elimination of ceftazidime by the renal route. Administration of probenecid before dosing had no effect on the elimination kinetics of ceftazidime. This suggested that ceftazidime is eliminated by glomerular filtration and is not actively secreted by renal tubular mechanisms.

Since ceftazidime is eliminated almost solely by the kidneys, its serum half-life is significantly prolonged in patients with impaired renal function. Consequently, dosage adjustments in such patients as described in the DOSAGE AND ADMINISTRATION section are suggested.

Therapeutic concentrations of ceftazidime are achieved in the following body tissues and fluids.

Table 2. Ceftazidime Concentrations in Body Tissues and Fluids
Tissue or Fluid Dose/Route No. of Patients Time of SamplePost Dose Average Tissue or Fluid Level(mcg/mL or mcg/g)
Urine 500 mg IM 6 0 to 2 hr 2,100
2 g IV 6 0 to 2 hr 12,000
Bile 2 g IV 3 90 min 36.4
Synovial fluid 2 g IV 13 2 hr 25.6
Peritoneal fluid 2 g IV 8 2 hr 48.6
Sputum 1 g IV 8 1 hr 9
Cerebrospinal fluid 2 g q8hr IV 5 120 min 9.8
(inflamed meninges) 2 g q8hr IV 6 180 min 9.4
Aqueous humor 2 g IV 13 1 to 3 hr 11
Blister fluid 1 g IV 7 2 to 3 hr 19.7
Lymphatic fluid 1 g IV 7 2 to 3 hr 23.4
Bone 2 g IV 8 0.67 hr 31.1
Heart muscle 2 g IV 35 30 to 280 min 12.7
Skin 2 g IV 22 30 to 180 min 6.6
Skeletal muscle 2 g IV 35 30 to 280 min 9.4
Myometrium 2 g IV 31 1 to 2 hr 18.7

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