Cefazolin sodium

Cefazolin sodium
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Black Box Warning

ConditionName: See full prescribing information for complete Boxed Warning. BEFORE THERAPY WITH CEFAZOLIN FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFAZOLIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFAZOLIN FOR INJECTION OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Overview

Cefazolin sodium is a semi-synthetic cephalosporin for parenteral administration that is FDA approved for the treatment of Respiratory Tract Infections,Urinary Tract Infections,Skin and Skin Structure Infections,Biliary Tract Infections,Bone and Joint Infections,Genital Infections,Septicemia, Endocarditis and Perioperative Prophylaxis.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Diarrhea,oral candidiasis,vomiting and nausea..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Respiratory Tract Infections due to S. pneumoniae, S. aureus (including beta-lactamase-producing strains) and S. pyogenes.
• Urinary Tract Infections due to E. coli, P. mirabilis.
• Skin and Skin Structure Infections due to S. aureus (including beta-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 beta-lactamase-producing strains), P. mirabilis, E. coli.
• Endocarditis due to S. aureus (including beta-lactamase-producing strains) and S. pyogenes.
• Perioperative Prophylaxis

• The prophylactic administration of Cefazolin for injection 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 Cefazolin for injection 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 Cefazolin for injection 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.

Dosage

Adult Dosage

Perioperative Prophylactic Use

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

• 1 gram IV administered ½ hour to 1 hour prior to the start of surgery.
• 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).
• 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 (½ 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.

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 ½ 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 ½ 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of cefazolin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of cefazolin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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.
• 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.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of cefazolin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of cefazolin in pediatric patients.

Contraindications

Cefazolin for injection is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Warnings

ConditionName: See full prescribing information for complete Boxed Warning. BEFORE THERAPY WITH CEFAZOLIN FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFAZOLIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFAZOLIN FOR INJECTION OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CEFAZOLIN FOR INJECTION, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• C. difficile produces toxins A and B which contribute to the development of CDAD.
• Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
• If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions

General

• Prolonged use of Cefazolin for injection may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential.
• When Cefazolin for injection is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required.
• As with other beta-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function.
• Cefazolin for injection, as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
• Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
• Prescribing Cefazolin for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

Clinical Trials Experience

• The following adverse reactions were reported from clinical trials:

Digestive

• Diarrhea
• oral candidiasis (oral thrush)
• mouth ulcers
• vomiting
• nausea
• stomach cramps
• epigastric pain
• heartburn
• flatus
• anorexia
• pseudomembranous colitis

• Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment

Hematologic and Lymphatic

• Neutropenia
• leukopenia
• thrombocytopenia
• thrombocythemia

Allergic

• Anaphylaxis
• eosinophilia
• urticaria
• itching
• drug fever
• skin rash
• Stevens-Johnson syndrome

Renal

• increased BUN and creatinine levels
• renal failure

Local Reactions

• phlebitis
• induration

Other reactions

• Pruritus (including genital, vulvar and anal pruritus, genital moniliasis, and vaginitis)
• Dizziness
• fainting
• lightheadedness
• confusion
• weakness
• tiredness
• hypotension
• somnolence
• headache

Cephalosporin-class Adverse Reactions

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
• superinfection
• seizures

Altered Laboratory Tests

• Prolonged prothrombin time
• positive direct Coombs' test
• false-positive test for urinary glucose
• elevated bilirubin
• elevated LDH
• increased creatinine
• pancytopenia
• agranulocytosis

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cefazolin in the drug label.

Drug Interactions

• Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels

Drug/Laboratory Test Interactions

• A false positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution or with CLINITEST® tablets, but not with enzyme-based tests such as CLINISTIX®.
• Positive direct and indirect antiglobulin (Coombs) tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

Pregnancy

Teratogenic Effects

• Reproduction studies have been performed in rats, mice and rabbits at doses up to 25 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Cefazolin for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pregnancy Category (AUS):

• There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefazolin in women who are pregnant.

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 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.

Geriatic 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

Gender

There is no FDA guidance on the use of Cefazolin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cefazolin with respect to specific racial populations.

Renal Impairment

• When CEFAZOLIN FOR INJECTION is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required

Hepatic Impairment

There is no FDA guidance on the use of Cefazolin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cefazolin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cefazolin in patients who are immunocompromised.

Administration and Monitoring

Administration

• intravenous

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.
• Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

Directions for Proper Use of a Pharmacy Bulk Package

• Not for direct infusion. The Pharmacy Bulk Package is for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the closure may be penetrated only one time using a suitable sterile dispensing set that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry, use entire contents of Pharmacy Bulk Package promptly. The entire contents of the Pharmacy Bulk Package should be dispensed within 4 hours of initial entry. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard Pharmacy Bulk Package within 4 hours after initial entry.

Pharmacy Bulk Packages

• Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium Chloride Injection according to the table below. Shake well.

Intermittent or continuous infusion

• Dilute reconstituted CEFAZOLIN FOR INJECTION 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

• When diluted according to the instructions above, Cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).
• Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

Monitoring

There is limited information regarding Monitoring of Cefazolin in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Cefazolin sodium in the drug label.

Overdosage

There is limited information regarding Overdose of Cefazolin in the drug label.

Pharmacology

There is limited information regarding Cefazolin sodium Pharmacology in the drug label.

Mechanism of Action

Structure

File:Cefazolin sodium01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cefazolin sodium in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cefazolin sodium in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cefazolin sodium in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cefazolin sodium in the drug label.

How Supplied

Storage

There is limited information regarding Cefazolin sodium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Cefazolin sodium in the drug label.

Precautions with Alcohol

• Alcohol-Cefazolin sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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