Cefazolin Sodium USP

CEFAZOLIN SODIUM USP

Novopharm

Antibiotic

Action And Clinical Pharmacology: Cefazolin is a cephalosporin antibiotic for parenteral administration. Cefazolin exerts its bactericidal effect by inhibiting bacterial cell wall synthesis. Cefazolin is about 85% bound to serum protein. The peak level in serum is approximately 32 to 42 mg/mL after an i.m. injection of 500 mg. Over 80% of injected cefazolin is excreted in the urine during the first 24 hours after i.m. injection; most is excreted during the first 4 to 6 hours. tag_IndicationsIndications

Indications And Clinical Uses: In the treatment of the following infections when caused by susceptible strains of the listed organisms:

Respiratory tract infections caused by S. pneumoniae, K. pneumoniae, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci.

Urinary tract infections caused by E. coli, P. mirabilis, K. pneumoniae and some strains of enterobacter, and enterococci. See Note below.

Skin and soft tissue infections caused by S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci and other strains of streptococci.

Bone and joint infections caused by S. aureus.

Septicemia caused by S. pneumoniae, S. aureus (penicillin-sensitive and penicillin-resistant), P. mirabilis, E. coli and K. pneumoniae. See Note below.

Endocarditis caused by S. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci.

Determine susceptibility of the causative organism to cefazolin by performing appropriate culture and susceptibility studies.

Note: Most strains of Enterococci, indole positive Proteus (P. vulgaris). E. cloacae, M. morganii, P. rettgeri and methicillin-resistant Staphylococci are resistant. Serratia, Pseudomonas and A. calcoaceticus (formerly Mima and Herellea species) are almost uniformly resistant to cefazolin.

Perioperative Prophylaxis: In patients undergoing potentially contaminated surgical procedures, and in patients in whom infection would pose a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty), the preoperative, intraoperative and postoperative administration of cefazolin may reduce the incidence of certain postoperative infections.

Identification of the causative organisms should be made by culture should signs of infection occur, so that appropriate therapy may be instituted.

Contra-Indications: In patients with known allergy to the cephalosporin group of antibiotics.

Manufacturers’ Warnings In Clinical States: Use with caution in penicillin-allergic patients. There is clinical evidence of partial cross-allergenicity of the penicillins and the cephalosporins. There are instances of patients who have had reactions to both penicillins and cephalosporins (including fatal anaphylaxis after parenteral use). Clinical and laboratory evidence of partial cross-allergenicity of the 2 drug classes exists.

Cefazolin should be administered cautiously and then only when absolutely necessary to any patient who has demonstrated allergy, particularly to drugs. Immediate emergency treatment with epinephrine is indicated for serious anaphylactoid reactions. As indicated, oxygen, i.v. steroids, and airway management, including intubation, should also be employed.

There have been reports of pseudomembranous colitis with the use of cephalosporins. It is therefore important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use.

Precautions: The overgrowth of nonsusceptible organisms may result from the prolonged use of cefazolin. It is essential that the patient be carefully observed.

In patients with a history of lower gastrointestinal disease, particularly colitis, cefazolin should be prescribed with caution. Clinitest tablets solution, but not enzyme-based tests such as Clinistix and Tes-Tape, may falsely indicate glucose in the urine of patients on cefazolin.

Positive direct and indirect Coombs’ tests have been reported during treatment with cefazolin. These may also occur in neonates whose mothers received cephalosporins before delivery. The clinical significance of this effect has not been established.

Renal Impairment: Caution should be exercised in treating patients with pre-existing renal damage although cefazolin has not shown evidence of nephrotoxicity.

Patients with low urinary output due to impaired renal function should be administered reduced daily dosages of cefazolin. (See Dosage, Patients with Reduced Renal Function.) Blood levels of cefazolin in dialysis patients remain fairly high and should be monitored.

Probenecid may decrease renal tubular secretion of cefazolin when used concurrently with cefazolin, resulting in increased and prolonged cefazolin blood levels.

In beta-hemolytic streptococcal infections, treatment should be continued for at least 10 days, to minimize possible complications associated with the disease.

Pregnancy: The safety of the use of cefazolin during pregnancy has not been established.

Lactation: Very low concentrations of cefazolin are found in the milk of nursing mothers. Cefazolin should be administered with caution to a nursing woman.

Children: The safety of the use of cefazolin in prematures and infants under 1 month of age has not been established.

Drug Interactions: The renal tubular secretion of cefazolin may be decreased when probenecid is used concurrently, resulting in increased and prolonged cefazolin blood levels.

Adverse Reactions: The following reactions have been reported:

Gastrointestinal: diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia. During antibiotic treatment symptoms of pseudomembranous colitis can appear. There have been rare reports of nausea and vomiting.

Allergic: Allergic reactions occur infrequently and include: anaphylaxis, eosinophilia, itching, drug fever, skin rash.

Hematologic: neutropenia, anemia, leukopenia, thrombocythemia, positive direct and indirect antiglobulin (Coombs’) tests.

Hepatic and Renal: Without clinical evidence of renal or hepatic impairment transient increases in AST, ALT, BUN and alkaline phosphatase levels have been observed. Transient hepatitis and cholestatic jaundice have been reported rarely, as with some penicillins and some other cephalosporins.

Local: Phlebitis at the site of injection has occurred rarely. Infrequently there is pain at the site of injection following i.m. injection. Some induration has been reported.

Other: vulvar pruritus, genital moniliasis, vaginitis and anal pruritus.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There is a lack of experience with acute cefazolin overdosage. Supportive therapy should be instituted according to symptoms in cases of suspected overdosage.

Dosage And Administration: After reconstitution cefazolin may be administered either i.m. or i.v. In both cases total daily dosages are the same.

Cefazolin has been administered in dosages of 6 g/day in serious infections such as endocarditis. Treatment should be continued for at least 10 days in beta-hemolytic streptococcal infections to minimize possible complications associated with the disease.

Patients with Reduced Renal Function: After an initial loading dose appropriate to the severity of the infection, the following reduced dosage schedule is recommended (see Table II).

Perioperative Prophylactic Use: The recommended dosage regimen to prevent postoperative infection in contaminated or potentially contaminated surgery is: a) 1 g i.v. or i.m. administered 1/2 hour to 1 hour prior to the start of surgery so that at the time of the initial surgical incision adequate antibiotic levels are present in the serum and tissues. b) For lengthy operative procedures (e.g., 2 hours or more) 0.5 to 1 g administered i.v. or i.m. during surgery. (Administration should be modified according to the duration of the operative procedure and the time of greatest exposure to infective organisms.) c) Postoperatively, 0.5 to 1 g i.v. or i.m. every 6 to 8 hours for 24 hours postoperatively. The prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery in which the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic athroplasty).

Children: A total daily dosage of 25 to 50 mg/kg of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections in children.

For severe infections total daily dosage may be increased to 100 mg/kg of body weight. The use of cefazolin in prematures and in infants under 1 month is not recommended since the safety for use in these patients has not been established.

Treatment with 60% of the normal daily dose may be administered in divided doses every 12 hours to children with mild to moderate renal impairment (Ccr 0.67 to 1.17 mL/s). Children with moderate to severe renal impairment (Ccr 0.33 to 0.87 mL/s) should be given 25% of the normal daily dose in equally divided doses every 12 hours, and children with severe renal impairment (Ccr 0.08 to 0.33 mL/s) should receive 10% of the normal daily dose every 24 hours.

All dosage recommendations apply after an initial loading dose.

Administration: Note: See Reconstitution and Dilution directions below: I.M.: Inject the reconstituted solution into a large muscle mass. Pain on injection of cefazolin occurs infrequently.

I.V.: Direct (bolus) Injection: Inject the appropriately diluted reconstituted solution slowly over 3 to 5 minutes directly into a vein or through tubing for patients receiving parenteral fluids. (See list of solutions for i.v. infusion.)

Intermittent or Continuous Infusion: The reconstituted solution can be administered along with primary i.v. fluid management programs in a volume control set or in a separate secondary i.v. bottle. (See list of solutions for i.v. infusion.)

Reconstituted Solutions: Parenteral drug products should be shaken well when reconstituted, and inspected visually for particulate matter prior to administration. The drug solutions should be discarded if particulate matter is evident in reconstituted fluids.

Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Reconstituted cefazolin may be stored for 24 hours at controlled room temperature not exceeding 25°C, or for 72 hours under refrigeration (2 to 8°C), protected from light.

Cefazolin solution reconstituted with bacteriostatic diluent and used for i.m. administration as multiple-dose containers should be used within 6 days when stored under refrigeration.

The pharmacy bulk vial is intended for multiple dispensing for i.v. use only, employing a single puncture. Following reconstitution, the solution should be dispensed and diluted for use within 8 hours. Any unused reconstituted solution should be discarded after 8 hours.

Direct I.V. (bolus) Injection: Single Dose Vial: Reconstitute as directed above. Shake well. A minimum of 10 mL of Sterile Water for Injection should be used to dilute the reconstituted solution.

Pharmacy Bulk Vial: Pharmacy Bulk Vials should be used for i.v. use only. Add, according to Table VI, Sterile Water for Injection, Bacteriostatic Water for Injection, or Sodium Chloride Injection. Shake well.

The vial is intended for single puncture and multiple dispensing, and the vial contents should be used within 8 hours.

Intermittent or continous i.v. infusion, reconstituted cefazolin may be further diluted as follows: Single Dose Vials: Reconstitute according to Table V. Shake well. Further dilute the reconstituted cefazolin in 50 to 100 mL of Sterile Water for Injection or 50 to 100 mL of one of the following solutions: Sodium Chloride Injection 0.9%, Dextrose Injection 5% or 10%, Dextrose 5% in Lactated Ringer’s Injection, Dextrose 5% and Sodium Chloride Injection 0.9% (also may be used with Dextrose 5% and Sodium Chloride Injection 0.45% or 0.2%), Lactated Ringer’s Injection, Ringer’s Injection, Sodium Bicarbonate 5% in Sterile Water for Injection.

Pharmacy Bulk Vial: Reconstitute according to Table VI. Shake well. Further dilute aliquots in 50 to 100 mL of Sterile Water for Injection or one of the solutions listed above.

The further diluted solutions above should be used within 24 hours at room temperature or 72 hours under refrigeration from the time of initial puncture.

Extended Use of I.V. Admixtures: Although i.v. admixtures may often be physically and chemically stable for longer periods, due to microbiological considerations, they are usually recommended for use within the maximum of 24 hours at room temperature or 72 hours when refrigerated (2 to 8°C).

Hospitals and institutions, that have recognized admixture programs and use validated aseptic techniques for preparation of i.v. solutions, may extend the storage times for cefazolin in admixtures with 5% Dextrose Injection or 0.9% Sodium Chloride Injection in Viaflex bags in 80 mg/mL concentrations to 30 days when stored under refrigeration (2 to 8°C) and in 5 mg/mL concentrations to 72 hours when stored under refrigeration (2 to 8°C).

Availability And Storage: 500 mg: Each clear glass vial of sterile powder contains: cefazolin 500 mg. Preservative-free.

1 g: Each clear glass vial of sterile powder contains: cefazolin 1 g. Preservative-free.

10 g: Each pharmacy bulk vial of sterile powder contains: cefazolin 10 g. Preservative-free. The availability of the pharmacy bulk vial is intended for hospitals with a recognized i.v. admixture program.

Store between 15 and 25°C, protect from light.

CEFAZOLIN SODIUM USP Novopharm Antibiotic

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