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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.
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.
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
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.
