Cefazolin sodium

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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.

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.

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.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

There is no FDA guidance on use of Cefazolin sodium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cefazolin sodium with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cefazolin sodium with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cefazolin sodium with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cefazolin sodium 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

Drug Shortage Status

Price

References

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

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