pharmacopeia
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/api/v1/drug/cefazolin

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Enzyme Inhibitors.

Enzyme

Indications

Sourced from openFDA
  • Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when due to susceptible organisms. Respiratory Tract Infections: Due to S.

Contraindications

Sourced from openFDA
  • CEFAZOLIN FOR INJECTION IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.contraindicated

Dosage & administration

Sourced from openFDA

Usual Adult Dosage: 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 * In rare instances, doses of up to 12 grams of Cefazolin for Injection per day have been used. Perioperative Prophylactic Use : To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: a. 1 gram I.V. or I.M. administered ½ 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 I.V. or I.M. during surgery (administration modified depending on the duration of the operative procedure). c. 500 mg to 1 gram I.V. or I.M. every 6 to 8 hours for 24 hours postoperatively. It is important that (1) the preoperative dose be given just prior (1/2 hour to 1 hour) 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.

Warnings & precautions

Sourced from openFDA

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. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefazolin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic‑associated colitis.” After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.

Adverse reactions

Sourced from openFDA

The following reactions have been reported: Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia, and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Nausea and vomiting have been reported rarely. Allergic: Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens‑Johnson syndrome. Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia. Hepatic: Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received. Renal: As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received. Local Reactions: Rare instances of phlebitis have been reported at site of injection. Pain at the site of injection after intramuscular administration has occurred infrequently. Some induration has occurred. Other Reactions: Genital and anal pruritus (including vulvar pruritus, genital moniliasis, and vaginitis). To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov .

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: Pregnancy Category B. 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.

Approval history

Sourced from openFDA
  • Dec 9, 1988ANDAANDA062831Sandoz
  • Jul 27, 2000NDANDA050779B Braun
  • Sep 18, 2001ANDAANDA065047Hikma Farmaceutica
  • Oct 18, 2004ANDAANDA065143Hikma Farmaceutica
  • Nov 29, 2006ANDAANDA065141Samson Medcl
  • Aug 7, 2015NDANDA207131Baxter Hlthcare Corp
  • Oct 7, 2022NDANDA216109Hikma
  • May 8, 2023NDANDA211413Hq Spclt Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
11,775 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Hypotension6885.8%
  2. 2Drug Ineffective6515.5%
  3. 3Anaphylactic Reaction6245.3%
  4. 4Anaphylactic Shock5804.9%
  5. 5Rash5754.9%
  6. 6Pyrexia5034.3%
  7. 7Renal Failure4874.1%
  8. 8Acute Kidney Injury4273.6%
  9. 9Pain4133.5%
  10. 10Off Label Use4043.4%
  11. 11Nausea3693.1%
  12. 12Urticaria3493.0%
  13. 13Drug Hypersensitivity3262.8%
  14. 14Dyspnoea3252.8%
  15. 15Erythema3122.6%

Literature

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Recent PubMed references pinned to Cefazolin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 269 ClinicalTrials.gov registrations naming Cefazolin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cefazolin work?
Mechanism-of-action class: Enzyme Inhibitors.
What is Cefazolin used for?
According to FDA labeling, Cefazolin carries indications including: Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when due to susceptible organisms. Respiratory Tract Infections: Due to S.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cefazolin?
Cefazolin is classified as First-generation cephalosporins, Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.
What are the contraindications for Cefazolin?
Cefazolin labeling lists contraindications including: CEFAZOLIN FOR INJECTION IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.. Always consult the full prescribing information and a clinician.
Note. Data for cefazolin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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