Ceftazidime 2 g/1
ceftazidime · INJECTION, POWDER, FOR SOLUTION · Sagent Pharmaceuticals
Ceftazidime is a injection, powder, for solution containing ceftazidime at 2 g/1, taken intravenous. Manufactured by Sagent Pharmaceuticals.
Key Facts
- Brand Name
- Ceftazidime
- Generic Name
- ceftazidime
- NDC Code (Product)
25021-128- Manufacturer
- Sagent Pharmaceuticals
- Strength
- 2 g/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA062640
- Marketing Start
- 05/15/2008
Recall History
Oregon Compounding Centers, Inc. dba Creative Compounds
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Walgreens Infusion Services
Lack of sterility assurance.
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Wells Pharmacy Network LLC
Lack of Assurance of Sterility
B. Braun Medical Inc
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Edge Pharma, LLC
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Pine Pharmaceuticals, LLC
Lack of Assurance of Sterility
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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: 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). 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). 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. Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp.,…
Dosage & Administration
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 ceftazidime for injection are listed in Table 3 . The following dosage schedule is recommended. Table 3. Recommended Dosage Schedule *Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. **The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis. Dose Frequency Adult Usual recommended dosage 1 gram intravenous or intramuscular every 8 to 12 hours Uncomplicated urinary tract infection 250 mg intravenous or intramuscular every 12 hours Bone and joint infections 2 grams intravenous every 12 hours Complicated urinary tract infections 500 mg intravenous or intramuscular every 8 to 12 hours Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg to 1 gram intravenous or int…
Warnings
WARNINGS BEFORE THERAPY WITH CEFTAZIDIME FOR INJECTION 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 CEFTAZIDIME FOR INJECTION 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 for injection, 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 cont…
Contraindications
CONTRAINDICATIONS Ceftazidime for injection 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 Ceftazidime used for?
Ceftazidime contains ceftazidime. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Ceftazidime a controlled substance?
Ceftazidime is not classified as a controlled substance by the DEA.
What is the generic name for Ceftazidime?
The generic name for Ceftazidime is ceftazidime. There are 6 other brand versions of ceftazidime.
What is the NDC code for Ceftazidime 2 g/1?
The NDC (National Drug Code) for Ceftazidime 2 g/1 is 25021-128, listed by Sagent Pharmaceuticals.