Ancef (Cefazolin Sodium) - Indications and Dosage

INDICATIONS AND USAGE

ANCEF is indicated in the treatment of the following infections due to susceptible organisms:

Respiratory Tract Infections

Due to S.   pneumoniae, S   aureus (including β-lactamase−producing strains) and S.   pyogenes.

Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

ANCEF is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of ANCEF in the subsequent prevention of rheumatic fever are not available.

Urinary Tract Infections

Due to E.   coli, P   mirabilis.

Skin and Skin Structure Infections

Due to S.   aureus (including β-lactamase−producing strains), S.   pyogenes, and other strains of streptococci.

Biliary Tract Infections

Due to E.   coli, various strains of streptococci, P.   mirabilis, and S.   aureus.

Bone and Joint Infections

Due to S.   aureus.

Genital Infections

(i.e., prostatitis, epididymitis) due to E.   coli, P.   mirabilis.

Septicemia

Due to S.   pneumoniae, S.   aureus (including β-lactamase−producing strains), P.   mirabilis, E.   coli.

Endocarditis

Due to S.   aureus (including β-lactamase−producing strains) and S.   pyogenes.

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

Perioperative Prophylaxis

The prophylactic administration of ANCEF preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones).

The perioperative use of ANCEF may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty).

The prophylactic administration of ANCEF 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 ANCEF may be continued for 3 to 5 days following the completion of surgery.

If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted.

(See DOSAGE AND ADMINISTRATION.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ANCEF and other antibacterial drugs, ANCEF should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

Usual Adult Dosage

Type of Infection	Dose	Frequency
Moderate to severe infections	500 mg to 1 gram	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

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

Perioperative Prophylactic Use

To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

a. 1 gram IV or IM administered ¹/₂ hour to 1 hour prior to the start of surgery.

b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

c. 500 mg to 1 gram IV or IM 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) ANCEF 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 ANCEF may be continued for 3 to 5 days following the completion of surgery.

Dosage Adjustment for Patients With Reduced Renal Function

ANCEF 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 3.0 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 ANCEF 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	9.0	75 mg	0.60 mL	55 mg	0.45 mL
30	13.6	115 mg	0.90 mL	85 mg	0.70 mL
40	18.1	150 mg	1.20 mL	115 mg	0.90 mL
50	22.7	190 mg	1.50 mL	140 mg	1.10 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	9.0	150 mg	0.70 mL	110 mg	0.50 mL
30	13.6	225 mg	1.00 mL	170 mg	0.75 mL
40	18.1	300 mg	1.35 mL	225 mg	1.00 mL
50	22.7	375 mg	1.70 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.

RECONSTITUTION

Preparation of Parenteral Solution

Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

When reconstituted or diluted according to the instructions below, ANCEF is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Single-Dose Vials

For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

Vial Size	Amount of Diluent	Approximate Concentration	Approximate Available Volume
1 gram	2.5 mL	330 mg/mL	3.0 mL

Pharmacy Bulk Vials

Add Sterile Water for Injection, Bacteriostatic Water for Injection, or Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard vial within 4 hours after initial entry.)

Vial Size	Amount of Diluent	Approximate Concentration	Approximate Available Volume
10 grams	45 mL	1 gram/5 mL	51 mL
	96 mL	1 gram/10 mL	102 mL

“Piggyback” Vials

Reconstitute with 50 to 100 mL of Sodium Chloride Injection or other IV solution listed under ADMINISTRATION. When adding diluent to vial, allow air to escape by using a small vent needle or by pumping the syringe. SHAKE WELL. Administer with primary IV fluids, as a single dose.

ADMINISTRATION

Intramuscular Administration

Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. ANCEF should be injected into a large muscle mass. Pain on injection is infrequent with ANCEF.

Intravenous Administration

Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

Intermittent or continuous infusion: Dilute reconstituted ANCEF in 50 to 100 mL of 1 of the following solutions:

Sodium Chloride Injection, USP

5% or 10% Dextrose Injection, USP

5% Dextrose in Lactated Ringer’s Injection, USP

5% Dextrose and 0.9% Sodium Chloride Injection, USP

5% Dextrose and 0.45% Sodium Chloride Injection, USP

5% Dextrose and 0.2% Sodium Chloride Injection, USP

Lactated Ringer’s Injection, USP

Invert Sugar 5% or 10% in Sterile Water for Injection

Ringer’s Injection, USP

5% Sodium Bicarbonate Injection, USP

HOW SUPPLIED

ANCEF

Single-Dose Vials

Each vial contains cefazolin sodium equivalent to 1 gram of cefazolin.

NDC 0007-3130-16 (package of 25 vials)

“Piggyback” Vials

Each vial contains cefazolin sodium equivalent to 1 gram of cefazolin.

NDC 0007-3137-05 (package of 10 "piggyback" vials)

Pharmacy Bulk Vials

Each vial contains cefazolin sodium equivalent to 10 grams of cefazolin.

NDC 0007-3135-05 (package of 10 pharmacy bulk vials)

As with other cephalosporins, ANCEF tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.

Before reconstitution protect from light and store at Controlled Room Temperature 20° to 25°C (68° to 77°F).