ANCEF PRESCRIBING INFORMATION PDF

If you are a consumer or patient please visit this version. Cefazolin injection is a cephalosporin antibacterial indicated for preoperative prophylaxis. Limitations of Use: Use an alternative cefazolin product when lengthy surgical procedures require supplemental doses and when postoperative dosing is required. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin injection and other antibacterial drugs, Cefazolin injection should be used only to prevent infections that are proven or strongly suspected to be caused by bacteria. Hypersensitivity to cefazolin or other cephalosporin antibacterial drugs, penicillins, or other beta-lactam drugs.

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If you are a consumer or patient please visit this version. Cefazolin injection is a cephalosporin antibacterial indicated for preoperative prophylaxis. Limitations of Use: Use an alternative cefazolin product when lengthy surgical procedures require supplemental doses and when postoperative dosing is required. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin injection and other antibacterial drugs, Cefazolin injection should be used only to prevent infections that are proven or strongly suspected to be caused by bacteria.

Hypersensitivity to cefazolin or other cephalosporin antibacterial drugs, penicillins, or other beta-lactam drugs. Most common adverse reactions with cefazolin are nausea, vomiting, diarrhea, and allergic reactions anaphylaxis, urticaria, skin rash. Probenecid: The renal excretion of cefazolin is inhibited by probenecid. Co-administration of probenecid with cefazolin is not recommended.

Pediatric use: The safety and effectiveness of Cefazolin injection in pediatric patients have not been established. Cefazolin injection is indicated for preoperative prophylaxis.

The prophylactic administration of cefazolin preoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated e.

The preoperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. Use an alternative cefazolin product when lengthy surgical procedures require supplemental doses and when postoperative dosing is required.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin injection and other antibacterial drugs, Cefazolin injection should be used only to prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefazolin injection is contraindicated in patients who have a history of immediate hypersensitivity reactions e. Serious and occasionally fatal hypersensitivity anaphylactic reactions have been reported in patients receiving beta-lactam antibacterial drugs.

Before therapy with Cefazolin injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. If an allergic reaction to Cefazolin injection occurs, discontinue the drug. Clostridium difficile -associated diarrhea CDAD has been reported with use of nearly all antibacterial agents, including cefazolin, 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. Hypertoxin-producing isolates of C. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C.

Hypersensitivity reactions, including anaphylaxis, have been reported with administration of dextrose-containing products. These reactions have been reported in patients receiving high concentrations of dextrose i. Prescribing Cefazolin injection in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antimicrobials, prolonged use of Cefazolin injection may result in overgrowth of nonsusceptible microorganisms. Repeated evaluation of the patient's condition is essential. Should superinfection occur during therapy, appropriate measures should be taken. It is recommended that glucose tests based on enzymatic glucose oxidase reactions e. Positive direct Coombs' tests have been reported during treatment with cefazolin.

In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibacterial drugs before parturition, it should be recognized that a positive Coombs' test may be due to the drug.

As with other dextrose-containing solutions, maintain clinical supervision when prescribing Cefazolin injection to patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason. The following serious adverse reactions to cefazolin are described below and elsewhere in the labeling:. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Gastrointestinal: Diarrhea, oral candidiasis, mouth ulcers, vomiting, nausea, stomach cramps, epigastric pain, heartburn, flatus, anorexia and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [ see Warnings and Precautions 5. Allergic: Anaphylaxis, eosinophilia, urticaria, itching, drug fever, skin rash, Stevens-Johnson syndrome. Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.

Hepatic: Transient rise in alanine aminotransferase ALT , aspartate aminotransferase AST , hepatitis and alkaline phosphatase levels has been observed.

Other Reactions: Pruritus including genital, vulvar and anal pruritus, genital moniliasis, and vaginitis. Dizziness, fainting, lightheadedness, confusion, weakness, tiredness, hypotension, somnolence and headache.

In addition to the adverse reactions listed above that have been observed in patients treated with cefazolin, the following adverse reactions and altered laboratory tests have been reported for cephalosporin antibacterial drugs: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal impairment, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic impairment including cholestasis, and pancytopenia.

The renal excretion of cefazolin is inhibited by probenecid. There was no evidence of impaired fertility or harm to the fetus due to cefazolin. When cefazolin has been administered prior to caesarean section, drug concentrations in cord blood have been approximately one quarter to one third of maternal drug levels. The drug appears to have no adverse effect on the fetus. Cefazolin is present in very low concentrations in the milk of nursing mothers.

Caution should be exercised when Cefazolin injection is administered to a nursing woman. The safety and effectiveness of Cefazolin injection in pediatric patients have not been established. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [ see Dosage and Administration 2.

Cefazolin Injection is a frozen, premixed, iso-osmotic, sterile, nonpyrogenic, single-dose mL solution containing 2 g Cefazolin, USP, equivalent to 2. Dextrose, USP has been added to adjust osmolality 4 g as dextrose hydrous.

Cefazolin Sodium is a semi-synthetic cephalosporin antibacterial for parenteral administration and has the following IUPAC nomenclature: Sodium 6 R ,7 R [[ 5-methyl-1,3,4-thiadiazolyl thio]methyl]oxo[2- 1 H -tetrazolyl acetamido]thiaazabicyclo[4. Water for injection, USP is added as drug vehicle.

Contains no preservative. The solution is intended for intravenous use after thawing to room temperature. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period.

However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. Cefazolin is a cephalosporin antibacterial drug [ see Microbiology The serum half-life for cefazolin is approximately 1. In a study, using normal volunteers, of constant intravenous infusion with dosages of 3. Studies in patients hospitalized with infections indicate that cefazolin produces mean peak serum concentrations approximately equivalent to those seen in normal volunteers.

Bile concentrations in patients without obstructive biliary disease can reach or exceed serum concentrations by up to five times; however, in patients with obstructive biliary disease, bile concentrations of cefazolin are considerably lower than serum concentrations less than 1.

In synovial fluid, the cefazolin concentration becomes comparable to that reached in serum at about 4 hours after drug administration. Studies of cord blood show prompt transfer of cefazolin across the placenta. Cefazolin is excreted unchanged in the urine. Predominant mechanisms of bacterial resistance to cephalosporins include the presence of extended-spectrum beta-lactamases and enzymatic hydrolysis.

Gram-positive Bacteria Staphylococcus aureus methicillin-susceptible isolates only Streptococcus agalactiae Streptococcus pyogenes. Escherichia coli Proteus mirabilis. Most isolates of indole positive Proteus Proteus vulgaris , Enterobacter spp. Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of cefazolin have not been performed.

Handle frozen product containers with care. Product containers may be fragile in the frozen state. Any other trademarks, product brands or images appearing herein are the property of their respective owners. Code 2G Sterile Nonpyrogenic Iso-osmotic. Dosage: For Intravenous Infusion Only. See prescribing information. Caution: Do not add supplemental medication or additives. Product should not be thawed by immersion in water baths or by microwave irradiation.

Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 48 hours at room temperature. Baxter and Galaxy are trademarks of Baxter International Inc. Do not refreeze. PL Plastic. Each bag contains mL. Baxter and Galaxy are registered trademarks of Baxter International Inc. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

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Generic Name: cefazolin sodium Dosage Form: for Injection. Medically reviewed by Drugs. Last updated on Nov 21, The Ancef brand name has been discontinued in the U. If generic versions of this product have been approved by the FDA, there may be generic equivalents available. Ancef is a semi-synthetic cephalosporin for parenteral administration. The serum half-life for Ancef is approximately 1.

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