Cefazolin Dailymed

2 Dosage And Administration

• For Intravenous Infusion only (2.1)
• Not for Intravenous bolus administration or intramuscular administration (2.1)

Recommended Dosage in Adult Patients with  CLcr that is greater than or equal to 55 mL/min  (2.2)

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
Perioperative prophylaxis	1 gram	½ to 1 hour prior to start of surgery
	500 mg to 1 gram	during surgery for lengthy procedures (e.g., 2 hours or more)
	500 mg to 1 gram	every 6 to 8 hours for 24 hours postoperatively

* In rare instances, doses of up to 12 grams of cefazolin per day have been used.



Recommended Dosage in Pediatric Patients with CLcr that is greater than or equal to 70 mL/min (2.3)

Type of Infection	Dose	Frequency
Mild to moderately severe infections	25 mg per kg to 50 mg per kg	divided into 3 or 4 equal doses
Severe infections	May increase to 100 mg per kg	divided into 3 or 4 equal doses

• Dosage adjustment is required for adult patients with CLcr that is less than 55 mL/min and pediatric patients with CLcr that is less than 70 mL/min (2.5)
• See full prescribing information for preparation and administration instructions (2.6)

2.1 Important Administration Instructions

Administer Cefazolin for Injection by Intravenous Infusion only. Not for Intravenous bolus administration or Intramuscular administration.

2.2 Dosage for the Treatment of Infections

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

The recommended adult dosages of Cefazolin for Injection for the treatment of infections [see Indications and Usage (1.1 to 1.8)] are outlined in Table 1 below. Administer Cefazolin for Injection by intravenous infusion [see Dosage and Administration (2.6)].

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

*ln rare instances, doses of up to 12 grams of Cefazolin for Injection per day have been used.

Dosage for the Treatment of Infections in Pediatric Patients 1 Month of Age and Older 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 by

Intravenous Infusion [see Dosage and Administration (2.6)].

Table 2: Recommended Dosage in Pediatric Patients 1 Month of Age and Older 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 moderately severe 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 Prophylactic Use in Adults

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. Administer Cefazolin for

Injection by Intravenous Infusion. Not for Intravenous bolus administration or Intramuscular administration [see Dosage and Administration (2.5, 2.6)].

 

 

Table 3: Recommended Dosage for Perioperative Prophylaxis in Adults with CLcr of 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 post-operatively
1 g	500 mg to 1 gram	500 mg to 1 gram every 6 hours to 8 hours

It is important that (1) the preoperative dose be given just (1/2 hour to 1 hour) prior to the start of surgery so that adequate antibacterial 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 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 for Injection may be continued for 3 to 5 days following the completion of surgery.

2.4 Pediatric Dosage Preparation Guide

Table 4: Pediatric Dosage Guide 25 mg/kg/day Divided into 3 Doses

Weight	25 mg/kg/day Divided into 3 Doses
Kg	Approximate Single Dose mg/every 8 hours	Vol. (mL) needed with dilution of 136 mg/mL	Dose (mL) from final concentration 40 mg/mL	Dose (mL) from final concentration 30 mg/mL	Dose (mL) from final concentration 20 mg/mL
4.5	40 mg	0.29 mL	1	1.3	2
9	75 mg	0.55 mL	1.9	2.5	3.8
13.6	115 mg	0.85 mL	2.9	3.8	5.8
18.1	150 mg	1.1 mL	3.8	5	7.5
22.7	190 mg	1.4 mL	4.8	6.3	9.5

Table 5: Pediatric Dosage Guide 25 mg/kg/day Divided into 4 Doses

Weight	25 mg/kg/day Divided into 4 Doses
Kg	Approximate Single Dose mg/every 6 hours	Vol. (mL) needed with dilution of 136 mg/mL	Dose (mL) from final concentration 40 mg/mL	Dose (mL) from final concentration 30 mg/mL	Dose (mL) from final concentration 20mg/mL
4.5	30 mg	0.22 mL	0.8	1	1.5
9	55 mg	0.40 mL	1.4	1.8	2.8
13.6	85 mg	0.63 mL	2.1	2.8	4.3
18.1	115 mg	0.85 mL	2.9	3.8	5.8
22.7	140 mg	1.03 mL	3.5	4.7	7

Table 6: Pediatric Dosage Guide 50 mg/kg/day Divided into 3 Doses

Weight	50 mg/kg/day Divided into 3 Doses
Kg	Approximate Single Dose mg/every 8 hours	Vol. (mL) needed with dilution of 136 mg/mL	Dose (mL) from final concentration 40 mg/mL	Dose (mL) from final concentration 30 mg/mL	Dose (mL) from final concentration 20 mg/mL
4.5	75 mg	0.55 mL	1.8	2.5	3.7
9	150 mg	1.10 mL	3.7	5	7.5
13.6	225 mg	1.65 mL	5.6	7.5	11.2
18.1	300 mg	2.21 mL	7.5	10	15
22.7	375 mg	2.76 mL	9.3	12.5	18.7

Table 7: Pediatric Dosage Guide 50 mg/kg/day Divided into 4 Doses

Weight	50 mg/kg/day Divided into 4 Doses
Kg	Approximate Single Dose mg/every 6 hours	Vol. (mL) needed with dilution of 136 mg/mL	Dose (mL) from final concentration 40 mg/mL	Dose (mL) from final concentration 30 mg/mL	Dose (mL) from final concentration 20 mg/mL
4.5	55 mg	0.40 mL	1.4	1.8	2.8
9	110 mg	0.81 mL	2.8	3.7	5.5
13.6	170 mg	1.25 mL	4.3	5.7	8.5
18.1	225 mg	1.65 mL	5.6	7.5	11.3
22.7	285 mg	2.10 mL	7.1	9.5	14.3

2.5 Dosage Recommendations in Adult and Pediatric Patients with Renal Impairment

Dosage Recommendations in Adult Patients with CLcr less than 55 mL/min

The dosage recommendation of Cefazolin for Injection in adult patients with renal impairment (CLcr less than 55 mL/min) is outlined in Table 8 below.

Table 8: Dosage Recommendation for Adult Patients with CLcr Less than 55 mL/min
Creatinine Clearance	Dose	Frequency
35 to 54 mL/min	Recommended dose	every 8 hours or longer
11 to 34 mL/min	Half of recommended dose	every 12 hours
10 mL/min or less	Half of recommended dose	every 18 to 24 hours

*All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

Dosage Recommendations in Pediatric Patients 1 Month of Age and Older with CLcr less than 70 mL/min

The dosage recommendation of Cefazolin for Injection in pediatric patients 1 month of age and older with renal impairment (CLcr less than 70 mL/min) is outlined in Table 9 below.

Table 9: Recommended Dosage in Pediatric Patients 1 Month of Age and Older with CLcr Less than 70 mL/min
Creatinine Clearance	Recommended Dosage
40 to 70 mL/min	60% of the normal daily dose given in equally divided doses every 12 hours
20 to 40 mL/min	25% of the normal daily dose given in equally divided doses every 12 hours
5 to 20 mL/min	10% of the normal daily dose every 24 hours

*All dosage recommendations apply after an initial loading dose.

2.6 Preparation of Cefazolin for Injection

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded. Reconstituted solutions may range in color from pale yellow to yellow.

 

Reconstitution and Dilution

For intravenous infusion, reconstitute Cefazolin for Injection single-dose vials with Sterile Water for Injection according to Table 10 below and shake well. After reconstitution further dilute according to Table 10 using the following diluents:

For intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in one of the following solutions:

• Sodium Chloride Injection, USP
• 5% Dextrose Injection, USP

Discard unused portion.

Table 10: Volumes for Reconstitution and Dilution and Final Concentrations
Cefazolin for Injection Vial Contents	Amount of Sterile Water for Injection for Reconstitution	Approximate Reconstituted Concentrations	Recommended Diluent Volume	Approximate Final Concentratioins
2 gram	15 mL	136 mg/mL	50 mL or 100 mL	40 mg/mL or 20 mg/mL
3 gram	15 mL	196 mg/mL	100 mL	30 mg/mL

 

Storage of Reconstituted and Diluted Solutions

When reconstituted or diluted according to the instructions above, Cefazolin for Injection is stable for 24 hours at room temperature or for 7 days if stored under refrigeration at 2°C to 8°C (36°F to 46°F).