Drug: Cefazolin Injection

Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is a sterile, nonpyrogenic, single use, packaged combination of Cefazolin Sodium USP (lyophilized) and sterile iso-osmotic diluent in the DUPLEX sterile container. The DUPLEX Container is a flexible dual chamber container. After reconstitution the approximate osmolality for Cefazolin for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. The drug chamber is filled with sterile lyophilized Cefazolin Sodium USP, a semisynthetic cephalosporin and has the following IUPAC nomenclature: Sodium (6R, 7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. Cefazolin Sodium USP has the following structural formula: The sodium content is 48 mg/g of cefazolin sodium. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula: The molecular weight of Hydrous Dextrose USP is 198.17 Cefazolin Sodium USP is supplied as a lyophilized form equivalent to 1 g of cefazolin. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2 g). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. The DUPLEX Container is Latex-free, PVC-free, and Di (2-ethylhexyl) phthalate (DEHP)-free. The DUPLEX dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.Last reviewed on RxList: 2/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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The following reactions have been reported: Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Nausea and vomiting have been reported rarely. Allergic: Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens-Johnson syndrome. Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia. Hepatic: Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received. Renal: As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received. Local Reactions: Rare instances of phlebitis have been reported at site of injection. Some induration has occurred. Other Reactions:Genital and anal pruritus (including vulvar pruritus, genital moniliasis, and vaginitis). Read the Cefazolin Injection (cefazolin and dextrose for injection) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Usual Adult Dosage Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours *In rare instances, doses of up to 12 grams of cefazolin per day have been used. Perioperative Prophylactic Use To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:
  1. 1 gram IV administered 1/2 hour to 1 hour prior to the start of surgery.
  2. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).
  3. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.
It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery. Dosage Adjustment for Patients with Reduced Renal Function Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. DUPLEX® Drug Delivery System Directions for Use
  • To avoid inadvertent activation, DUPLEX Container should remain in the folded position until activation is intended.
Patient Labeling and Drug Powder/Diluent Inspection
  • Apply patient-specific label on foil side of container. USE CARE to avoid activation. Do not cover any portion of foil strip with patient label.
  • Unlatch side tab and unfold DUPLEX Contner. (See Diagram 1.)
  • Visually inspect diluent chamber for particulate matter.
  • Use only if container and seals are intact.
  • To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.)
  • Protect from light after removal of foil strip.
Note: If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.
  • The product should be re-folded and the side tab latched until ready to activate.
Reconstitution (Activation)
  • Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.
  • Unfold the DUPLEX Container and point the set port in a downward direction. Starting at the hnger tab end, fold the DUPLEX Container just below the diluent meniscus trapping all air above the fold. To activate. squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber. (See Diagram 3.)
  • Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration. Administration
  • Visually inspect the reconstituted solution for particulate matter.
  • Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port. (See Diagram 4.)
  • Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired.
  • Using aseptic technique, peel foil cover from the set port and attach sterile administration set. (See Diagram 5.)
  • Refer to Directions for Use accompanying the administration set.
Precautions
  • As with other cephalosporins, reconstituted Cefazolin for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.
  • Use only if prepared solution is clear and free from particulate matter.
  • Do not use in series connection.
  • Do not introduce additives into the DUPLEX® Container.
  • Do not freeze.

Source: http://www.rxlist.com

Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels. Drug/Laboratory Test Interactions A false positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution or with Clinitest® tablets, but not with enzyme-based tests such as Clinistix®. Positive direct and indirect antiglobulin (Coombs) tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.Last reviewed on RxList: 2/9/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is indicated in the treatment of the following infections due to susceptible organisms: Respiratory Tract Infections: Due to S. pneumoniae, S. aureus (including beta-lactamase-producing strains) and S. pyogenes. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available. Urinary Tract Infections: Due to E. coli, P. mirabilis. Skin And Skin Structure Infections: Due to S. aureus (including beta-lactamase-producing strains), S. pyogenes, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, and S. aureus. Bone And Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) Due to E. coli, P. mirabilis. Septicemia: Due to S. pneumoniae, S. aureus (including beta-lactamase-producing strains), P. mirabilis, E. coli. Endocarditis: Due to S. aureus (including beta-lactamase-producing strains) and S. pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin. Perioperative Prophylaxis: The prophylactic administration of cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery. 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. (See DOSAGE AND ADMINISTRATION.) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) and other antibacterial drugs, Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) should be used only to treat or 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.

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CEFAZOLIN FOR INJECTION USP AND DEXTROSE INJECTION USP (cefazolin and dextrose for injection) IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.Last reviewed on RxList: 2/9/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) in the DUPLEX Drug Delivery System is a flexible dual chamber container supplied in one concentration. After reconstitution, the concentration is equivalent to 1 g cefazolin. The diluent chamber contains approximately 50 mL of Dextrose Injection USP. Dextrose Injection USP has been adjusted to 4.0% for the 1 g dose, such that the reconstituted solution is iso-osmotic. Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System containers packaged 24 units per case. NDC Cat. No. Dose Volume Cefazolin for Injection USP and Dextrose Injection USP 0264-3103-11 3103-11 1g 50mL Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). Revised: April 2008. B. Braun Medical Inc. Irvine, CA USA 92614-5895. FDA Rev date: 10/31/2008 Last reviewed on RxList: 2/9/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Prolonged use of Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential. When Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required (see DOSAGE AND ADMINISTRATION). As with other beta-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function (see DOSAGE AND ADMINISTRATION). Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) , as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. As with other dextrose-containing solutions, Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) should be prescribed with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason. Prescribing Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) in the absence of a 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. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. Use only if solution is clear and container and seals are intact. Carcinogenesis/Mutagenesis Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) have not been performed. Pregnancy - Teratogenic Effects - Pregnancy Category B. Reproduction studies have been performed in rats, mice, and rabbits at doses up to 25 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefazolin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Labor and Delivery When cefazolin has been administered prior to caesarean section, drug levels 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. Nursing Mothers Cefazolin is present in very low concentrations in the milk of nursing mothers. Caution should be exercised when Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is administered to a nursing woman. Pediatric Use Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) is designed to deliver a 1 g dose of cefazolin. To prevent unintentional overdose, Cefazolin for Injection USP and Dextrose Injection USP (cefazolin and dextrose for injection) should not be used in pediatric patients who require less than the full adult dose of cefazolin. Geriatric Use Of the 920 subjects who received cefazolin in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. 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 PRECAUTIONS, General and DOSAGE AND ADMINISTRATION). Last reviewed on RxList: 2/9/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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