Cefazolin Sodium (Page 2 of 8)

2.2 Dosage for the Treatment of Infections

D osage for the Treatment of Infections in Adults with Creatinine Clearance (CLcr) Equal to 55 mL/min or Greater

The recommended adult dosages for the treatment of infections [see Indications and Usage (1.1 to 1.8)] are outlined in Table 1 below. Administer Cefazolin for Injection and Dextrose Injection intravenously over approximately 30 minutes.

*

If a dose of Cefazolin for Injection and Dextrose Injection is required that does not equal 1 gram or 2 grams, this product is not recommended for use and an alternative formulation of cefazolin should be considered.

In rare instances, doses of up to 12 grams of cefazolin per day have been used.
Table 1: Recommended Dosage in Adult Patients with CLcr Equal to 55 mL/min or Greater * .
Site and 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

Dosage for the Treatment of Infections in Pediatric Patients with CLcr Equal to 70 mL/min or Greater

The recommended pediatric dosages for the treatment of infections [see Indications and Usage (1.1 to 1.8)] are outlined in Table 2 below. Administer Cefazolin for Injection and Dextrose Injection intravenously over approximately 30 minutes.

If a dose of Cefazolin for Injection and Dextrose Injection is required that does not equal 1 gram or 2 grams, this product is not recommended for use and an alternative formulation of cefazolin should be considered [see Use in Specific Populations (8.4)].

Table 2: Recommended Dosage in Pediatric Patients with CLcr 70 mL/min or greater for Treatment of Infections [see Indications and Usage (1.1 to 1.8)]
Type of Severity Recommended Total Daily Dosage
Mild to moderate infections 25 mg/kg to 50 mg/kg, divided into 3 or 4 equal doses
Severe infections May increase to 100 mg/kg, divided into 3 or 4 equal doses

2.3 Dosage for Perioperative Prophylaxis

Dosage for Perioperative Prophylaxis in Adults with CLcr Equal to 55 mL/min or Greater

To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended dosages are described in Table 3 below.

Table 3: Recommended Dosage for Perioperative Prophylaxis in Adults with CLcr to 55 mL/min or Greater

Dose administered ½ hour to 1 hour prior to the start of surgery Additional dose during lengthy operative procedures (e.g., 2 hours or more) Dose for 24 hours postoperatively
1 g 2 g 500 mg to 1 g 500 mg to 1 g every 6 hours to 8 hours

If a dose of Cefazolin for Injection and Dextrose Injection is required that does not equal 1 gram or 2 grams, this product is not recommended and an alternative formulation of cefazolin should be considered.

It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

The perioperative 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 days to 5 days following the completion of surgery.

Dosage for Perioperative Prophyla xis in Pediatric Patients Aged 10 to 17 Years Old with CLcr 70 mL/min or Greater

To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are described in Table 4 below.

Table 4: Recommended Dosage for Perioperative Prophylaxis in Pediatric Patients with CLcr 70 mL/min or greater Aged 10 to 17 years Old *
Body weight (kg) Dose administered ½ to 1 hour prior to the start of surgery Additional dose during lengthy operative procedures (e.g., 2 hours or more) Dose for 24 hours postoperatively
Less than 50 kg 1 g 500 mg to 1 g 500 mg to 1 g every 6 hours to 8 hours
Greater than or equal to 50 kg 2 g

* If a dose of Cefazolin for Injection and Dextrose Injection is required that does not equal 1 gram or 2 grams, this product is not recommended for use and an alternative formulation of cefazolin should be considered.

It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

The administration of Cefazolin for Injection and Dextrose Injection for perioperative prophylaxis should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating the administration of Cefazolin for Injection and Dextrose Injection for perioperative prophylaxis may be continued for 3 days to 5 days following the completion of surgery.

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