Drugplain

TAZICEF 1 g/1

CEFTAZIDIME · INJECTION, POWDER, FOR SOLUTION · Hospira, Inc.

No Recall HistoryCurrently in Shortage
Plain English

TAZICEF is a injection, powder, for solution containing ceftazidime at 1 g/1, taken intramuscular. Manufactured by Hospira, Inc..

Key Facts

Brand Name
TAZICEF
Generic Name
CEFTAZIDIME
NDC Code (Product)
0409-5082
Manufacturer
Hospira, Inc.
Strength
1 g/1
Dosage Form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #
ANDA062662
Marketing Start
11/02/2005

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective841 reports
off label use672 reports
pyrexia537 reports
septic shock335 reports
condition aggravated327 reports
neutropenia320 reports
acute kidney injury305 reports
pneumonia298 reports
diarrhoea295 reports
febrile neutropenia271 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Tazicef (ceftazidime for injection, USP) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1. Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae , including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae ; and Staphylococcus aureus (methicillin-susceptible strains). 2. Skin and Skin-Structure Infections caused by Pseudomonas aeruginosa ; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci). 3. Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli . 4. Bacterial Septicemia caused by Pseudomonas ae

Dosage & Administration

DOSAGE AND ADMINISTRATION Dosage The usual adult dosage is 1 gram administered intravenously 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 Tazicef (ceftazidime for injection, USP) are listed in Table 3 . The following dosage schedule is recommended. Table 3. Recommended Dosage Schedule Dose Frequency Adult Usual recommended dosage 1 gram intravenous every 8 to 12 hours Uncomplicated urinary tract infection 250 mg intravenous every 12 hours Bone and joint infections 2 grams intravenous every 12 hours Complicated urinary tract infections 500 mg intravenous every 8 to12 hours Uncomplicated pneumonia; mild skin and skin- structure infections 500 mg to 1 gram intravenous every 8 hours Serious gynecological and intra-abdominal infections 2 grams intravenous every 8 hours Meningitis 2 grams intravenous every 8 hours Very severe life-threatening infections, especially in immunocompromised patients 2 grams intravenous every 8 hours Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with normal

Warnings

WARNINGS BEFORE THERAPY WITH TAZICEF IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, 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 ANTIBACTERIAL DRUGS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO TAZICEF OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ceftazidime, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin prod

Contraindications

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

Drug Interactions

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 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 aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials. Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo , particularly when bactericidal activity is desired, this drug combination should be avoided.

Adverse Reactions

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 IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported. The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology: Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients). Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash, and fever. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibacterial drugs, including ceftazidime. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely. Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156

Frequently Asked Questions

What is TAZICEF used for?

TAZICEF contains CEFTAZIDIME. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.

Is TAZICEF a controlled substance?

TAZICEF is not classified as a controlled substance by the DEA.

What is the generic name for TAZICEF?

The generic name for TAZICEF is CEFTAZIDIME. There are 7 other brand versions of CEFTAZIDIME.

What is the NDC code for TAZICEF 1 g/1?

The NDC (National Drug Code) for TAZICEF 1 g/1 is 0409-5082, listed by Hospira, Inc..

Product NDC

0409-5082

Package NDC

0409-5082-10

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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