Ancef (Cefazolin Sodium)

ANCEF®

SmithKline Beecham

Cefazolin Sodium

Antibiotic

Action And Clinical Pharmacology: Cefazolin sodium is a cephalosporin antibiotic for parenteral administration. It exerts its bactericidal action through inhibition of bacterial cell wall synthesis.

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

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

Genitourinary tract infections caused by E. coli, P. mirabilis, K. pneumoniae and some strains of enterobacter and enterococci.

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 (formerly D. pneumoniae), S. aureus (penicillin-sensitive and penicillin-resistant), P. mirabilis, E. coli and K. pneumoniae.

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

Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

Most strains of indole positive Proteus (P. vulgaris), E. cloacae, M. morganii, P. rettgeri and methicillin-resistant staphylococci are resistant. Serratia, Pseudomonas, Mima and Herellea species are almost uniformly resistant to cefazolin.

Perioperative Prophylaxis: Preoperative, intraoperative and postoperative administration 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).

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

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

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

Any patient who has demonstrated some form of allergy, particularly to drugs, should receive cefazolin cautiously and then only when absolutely necessary. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, i.v. steroids, and airway management, including intubation, should also be administered as indicated.

Pseudomembranous colitis has been reported with the use of cephalosporins; therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with antibiotic use.

Precautions: Prolonged use of cefazolin may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential.

Cefazolin should be prescribed with caution in patients with a history of lower gastrointestinal disease, particularly colitis. Although cefazolin has not shown evidence of nephrotoxicity, caution should be exercised in treating patients with pre-existing renal damage.

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

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

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.

A false-positive reaction for glucose in the urine of patients on cefazolin may occur with Clinitest tablets but not with enzyme-based tests such as Clinistix and Tes-Tape.

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

Pregnancy: Safety for use during pregnancy has not been established.

Children: Safety for use in premature infants and in infants under 1 month of age has not been established.

Lactation: Cefazolin is present in very low concentrations in the milk of nursing mothers. Caution should be exercised when cefazolin is administered to a nursing woman.

Adverse Reactions: The following reactions have been reported: Gastrointestinal: diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia. Symptoms of pseudomembranous colitis can appear during antibiotic treatment. Nausea and vomiting have been reported rarely.

Allergic: anaphylaxis, eosinophilia, itching, drug fever, skin rash.

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

Hepatic and Renal: Transient increases in AST, ALT, BUN and alkaline phosphatase levels have been observed without clinical evidence of renal or hepatic impairment.

Local Reactions: Rare instances of phlebitis have been reported at the site of injection. Pain at the site of injection after i.m. administration has occurred infrequently. Some induration has occurred.

Other Reactions: 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. In cases of suspected overdosage, supportive therapy should be instituted according to symptoms.

Dosage And Administration: Cefazolin may be administered i.m. or i.v. after reconstitution. Total daily dosages are the same in both cases. Perioperative Prophylaxis: To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dosage regimen is: a) 1 g i.v. or i.m. administered 0.5 hour 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 the initial surgical incision. b) For lengthy operative procedures (e.g., 2 hours or more) 0.5 to 1 g, 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) 0.5 g to 1 g i.v. or i.m. every 6 to 8 hours for 24 hours postoperatively. 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.

Children: In 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.

Total daily dosage may be increased to 100 mg/kg of body weight for severe infections. Since safety for use in premature infants and in infants under 1 month has not been established, the use of cefazolin in these patients is not recommended.

Children with mild to moderate renal impairment (CCr 0.67 to 1.17 mL/s) may be treated with 60% of the normal daily dose given in divided doses every 12 hours. Children with moderate 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 patients with severe renal impairment (CCr 0.08 to 0.33 mL/s) should receive 10% of the normal daily dose every 24 hours.

Administration: I.M.: Inject the reconstituted solution into a large muscle mass. Pain on injection is infrequent with cefazolin.

I.V.: Direct (bolus) injection: Inject the appropriately diluted reconstituted solution slowly over 3 to 5 minutes directly into 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).

Shake well and inspect visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

I.M. Injection: Shake well.

I.V. Direct (Bolus) Injection: Reconstitute as directed in Table V. Shake well. Dilute the reconstituted solution in a minimum of 10 mL of Sterile Water for Injection.

Intermittent or Continuous I.V. Shake well. Then further dilute reconstituted Ancef in 50 to 100 mL of Sterile Water for Injection or one of the Solutions for I.V. Infusion.

Solutions for I.V. Infusion: Sodium Chloride Injection, 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, Invert Sugar 5% or 10% in Sterile Water for Injection, Ringer’s Injection, Sodium Bicarbonate 5% in Sterile Water for Injection.

Stability and Storage of Parenteral Solutions: When reconstituted or diluted according to the instructions above, Ancef is stable for 24 hours at room temperature or for 96 hours if stored under refrigerated temperatures (2 to 8°C). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Pharmacy Bulk Vials: The Pharmacy Bulk Vial is intended for multiple dispensing for i.v. use only employing a single puncture. Any unused stock solution remaining after a period of 8 hours should be discarded.

Shake well and inspect visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

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 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 Ancef in admixtures with 5% Dextrose Injection or 0.9% Sodium Chloride Injection in Viaflex bags, in concentrations of 5 to 80 mg/mL, for 21 days when stored under refrigeration at 2 to 8°C.

Warning: As with all parenteral products, i.v. admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used.

Availability And Storage: Each 10 mL vial contains: cefazolin sodium equivalent to 500 mg or 1 g of cefazolin. Each 100 mL pharmacy bulk vial contains: cefazolin sodium equivalent to 10 g of cefazolin. Sodium: 46 mg/g of cefazolin. Preservative-free. Boxes of 10.

Store vials at normal room temperature. Protect from light. Under normal conditions of storage, the lyophilized form has a shelf life of 24 months.

ANCEF® SmithKline Beecham Cefazolin Sodium Antibiotic

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