Cefazolin (Page 3 of 4)

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

Pediatric Use

Safety and effectiveness for use in premature infants and neonates have not been established. See DOSAGE AND ADMINISTRATION for recommended dosage in pediatric patients older than 1 month.

Geriatric Use

Of the 920 subjects who received Cefazolin for injection 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).

ADVERSE REACTIONS

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).

Cephalosporin-class Adverse Reactions

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-class antibiotics:

Adverse Reactions: Allergic reactions, urticaria, serum sickness-like reaction, erythema multiforme, toxic epidermal necrolysis, colitis, renal dysfunction, toxic nephropathy, abdominal pain, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and superinfection.

Altered Laboratory Tests: Prolonged prothrombin time, positive direct Coombs’ test, false-positive test for urinary glucose, elevated bilirubin, elevated LDH, increased creatinine, pancytopenia, and agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

DOSAGE AND ADMINISTRATION

Usual Adult Dosage

Type of Infection Dose Frequency
*
ln rare instances, doses of up to 12 grams of Cefazolin for injection per day have been used.
Moderate to severe infections 500mg to 1gram every 6 to 8 hrs.
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

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 for injection 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 for injection may be continued for 3 to 5 days following the completion of surgery.

Dosage Adjustment for Patients with Reduced Renal Function

Cefazolin for injection 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 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. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

Pediatric Dosage

In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) 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 per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

Pediatric Dosage Guide
Weight 25 mg/kg/day
Divided into 3 Doses
25 mg/kg/day
Divided into 4 Doses
Lbs Kg Approximate Single Dose mg/q8h Vol.(mL)
needed with
dilution of 125 mg/mL
Approximate Single Dose mg/q6h Vol.(mL)
needed with dilution of 125 mg/mL
10 4.5 40 mg 0.35 mL 30 mg 0.25 mL
20 9 75 mg 0.6 mL 55 mg 0.45 mL
30 13.6 115 mg 0.9 mL 85 mg 0.7 mL
40 18.1 150 mg 1.2 mL 115 mg 0.9 mL
50 22.7 190 mg 1.5 mL 140 mg 1.1 mL
Weight
50 mg/kg/day
Divided into 3 Doses
50 mg/kg/day
Divided into 4 Doses
Lbs Kg Approximate Single Dose mg/q8h Vol.(mL)
needed with dilution of 225 mg/mL
Approximate Single Dose mg/q6h Vol.(mL)
needed with dilution of 225 mg/mL
10 4.5 75 mg 0.35 mL 55 mg 0.25 mL
20 9 150 mg 0.7 mL 110 mg 0.5 mL
30 13.6 225 mg 1 mL 170 mg 0.75 mL
40 18.1 300 mg 1.35 mL 225 mg 1 mL
50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

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