CEFAZOLIN (Page 4 of 4)

12.4 Microbiology

Mechanism of Action

Cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.

Resistance

Predominant mechanisms of bacterial resistance to cephalosporins include the presence of extended-spectrum beta-lactamases and enzymatic hydrolysis.

Antimicrobial Activity

Cefazolin has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE (1) section.

  • Gram-Positive Bacteria
    • Staphylococcus aureus
    • Staphylococcus epidermidis
    • Streptococcus agalactiae
    • Streptococcus pneumoniae
    • Streptococcus pyogenes

Methicillin-resistant staphylococci are uniformly resistant to cefazolin,

  • Gram-Negative Bacteria
    • Escherichia coli
    • Proteus mirabilis

Most isolates of indole positive Proteus (Proteus vulgaris), Enterobacter spp., Morganella morganii, Providencia rettgeri , Serratia spp. and Pseudomonas spp. are resistant to cefazolin.

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Cefazolin for Injection, USP have not been performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

Cefazolin for Injection, USP, is available in the following SmartPak® Pharmacy Bulk Packages bags:

100 grams * One Pharmacy Bulk Package bag Product No. 1100 NDC 66288-1100-1

300 grams ** One Pharmacy Bulk Package bag Product No. 1300 NDC 66288-1300-1

*Each 100 gram Pharmacy Bulk Package bag contains sterile cefazolin sodium equivalent to 100 grams of cefazolin.

**Each 300 gram Pharmacy Bulk Package bag contains sterile cefazolin sodium equivalent to 300 grams of cefazolin.

SmartPak ® system components are not made with natural rubber latex.

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

Storage Conditions

Prior to reconstitution, store dry powder at 20° to 25° C (68° to77° F). [See USP Controlled Room Temperature]. Protect From Light.

17 PATIENT COUNSELING INFORMATION

Patients should be advised that allergic reactions, including serious allergic reactions could occur and that serious reactions require immediate treatment and discontinuation of cefazolin. Patients should report to their health care provider any previous allergic reactions to cefazolin, cephalosporins, penicillins or other similar antibacterials.

Patients should be advised that diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterials. If this occurs, patients should contact a physician as soon as possible.

Patients should be counseled that antibacterial drugs including cefazolin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefazolin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefazolin or other antibacterial drugs in the future.

Rx only
SmartPak is a registered trademark of Samson Medical Technologies, L.L.C.
Clinitest is a registered trademark of Siemens Medical Solutions Diagnostics.
Clinistix is a registered trademark of Bayer Healthcare LLC.

C1100i

Manufactured for

​SAMSON MEDICAL TECHNOLOGIES, L.L.C.

Cherry Hill, NJ 08003

by

ACS Dobfar S.p.A.

20067 Tribiano (Milano) Italy

Principal Display Panel – 100 g Inner Bag Label

NDC 66288-1100-1 SMARTPAK®

CEFAZOLIN For Injection, USP

PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION

100 grams [ONE HUNDRED GRAMS] per Pharmacy Bulk Package Bag

FOR INTRAVENOUS USE ONLY

NOT TO BE DISPENSED AS A UNIT

Rx Only

Principal Display Panel – 100 g Inner Bag Label
(click image for full-size original)

Principal Display Panel – 100 g Outer Bag Label

NDC 66288-1100-1 SMARTPAK®

CEFAZOLIN For Injection, USP

PHARMACY BULK PACKAGENOT FOR DIRECT INFUSION

100 grams [ONE HUNDRED GRAMS] per Pharmacy Bulk Package Bag

FOR INTRAVENOUS USE ONLY

NOT TO BE DISPENSED AS A UNIT

Rx Only

Principal Display Panel – 100 g Outer Bag Label
(click image for full-size original)

Principal Display Panel – 300 g Inner Bag Label

NDC 66288-1300-1 SMARTPAK®

CEFAZOLIN For Injection, USP

PHARMACY BULK PACKAGE

NOT FOR DIRECT INFUSION

300 grams [THREE HUNDRED GRAMS] per Pharmacy Bulk Package Bag

FOR INTRAVENOUS USE ONLY

NOT TO BE DISPENSED AS A UNIT

Rx Only

Principal Display Panel – 300 g Inner Bag Label
(click image for full-size original)

Principal Display Panel – 300 g Outer Bag Label

NDC 66288-1300-1 SMARTPAK®

CEFAZOLIN For Injection, USP

PHARMACY BULK PACKAGE

NOT FOR DIRECT INFUSION

300 grams [THREE HUNDRED GRAMS] per Pharmacy Bulk Package Bag

FOR INTRAVENOUS USE ONLY

NOT TO BE DISPENSED AS A UNIT

Rx Only

Principal Display Panel – 300 g Outer Bag Label
(click image for full-size original)
CEFAZOLIN cefazolin sodium injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66288-1100
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cefazolin Sodium (Cefazolin) Cefazolin 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66288-1100-1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065141 01/01/2007
CEFAZOLIN cefazolin sodium injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66288-1300
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cefazolin Sodium (Cefazolin) Cefazolin 300 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66288-1300-1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065141 01/01/2007
Labeler — Samson Medical Technologies, L.L.C. (102837429)
Establishment
Name Address ID/FEI Operations
ACS Dobfar S.p.A. 429243025 MANUFACTURE (66288-1100), MANUFACTURE (66288-1300)

Revised: 12/2019 Samson Medical Technologies, L.L.C.

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