FORTAZ Powder for solution for injection (2017)

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1. 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]-, ...

2. 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 ...

3. Indications and Usage

FORTAZ is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: <b>Lower Respiratory Tract Infections</b>, including ...

4. Contraindications

FORTAZ is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibacterial drugs.

5. Warnings

BEFORE THERAPY WITH FORTAZ IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER ...

6. Precautions

Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to ...

6.1. General

High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage ...

6.2. Information for Patients

Patients should be counseled that antibacterial drugs, including FORTAZ, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When FORTAZis prescribed ...

6.4. Drug Interactions

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully ...

6.5. Drug/Laboratory Test Interactions

The administration of ceftazidime may result in a false-positive reaction for glucose in the urine when using Clinitest tablets, Benedicts solution, or Fehlings solution. It is recommended that glucose ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects.

6.9. Nursing Mothers

Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when FORTAZ is administered to a nursing woman.

6.10. Pediatric Use

See DOSAGE AND ADMINISTRATION.

6.11. Geriatric Use

Of the 2,221 subjects who received ceftazidime in 11 clinical studies, 824 (37%) were 65 and older while 391 (18%) were 75 and older. No overall differences in safety or effectiveness were observed between ...

7. Adverse Reactions

Ceftazidime is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following ...

9. Overdosage

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute ...

10. Dosage and Administration

<b>For Intravenous or Intramuscular Use.</b> To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat ...

11. How Supplied

FORTAZ in the dry state should be stored between 15° and 30°C (59° and 86°F) and protected from light. FORTAZ is a dry, white to off-white powder supplied in vials as follows: NDC 52565-105-10 500-mg* ...

14. References

1. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.