CEFAZOLIN- cefazolin sodium injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Cefazolin Sodium (UNII: P380M0454Z) (Cefazolin - UNII:IHS69L0Y4T)

Available from:

Samson Medical Technologies, L.L.C.

INN (International Name):

Cefazolin Sodium

Composition:

Cefazolin 100 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin and other antibacterial drugs, cefazolin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefazolin for Injection is indicated for the treatment of the following infections when caused by susceptible bacteria. Respiratory tract infections due to Streptococcus pneumoniae , Staphylococcus aureus and Streptococcus pyogenes . Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, dat

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SAMSON MEDICAL TECHNOLOGIES, L.L.C.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFAZOLIN FOR INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFAZOLIN FOR
INJECTION, USP.
CEFAZOLIN FOR INJECTION, USP
INITIAL U.S. APPROVAL: 1973
PHARMACY BULK PACKAGE -
NOT FOR DIRECT INFUSION
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF CEFAZOLIN AND OTHER
ANTIBACTERIAL DRUGS, CEFAZOLIN SHOULD BE USED ONLY TO TREAT OR PREVENT
INFECTIONS THAT ARE PROVEN OR STRONGLY
SUSPECTED TO BE CAUSED BY BACTERIA. (12.4)
INDICATIONS AND USAGE
Cefazolin for Injection, USP is a cephalosporin antibacterial
indicated in the treatment of the following infections caused by
susceptible isolates of the designated microorganisms: Respiratory
tract infections (1.1); urinary tract infections (1.2); skin
and skin structure infections (1.3); biliary tract infections (1.4);
bone and joint infections (1.5); genital infections (1.6);
septicemia (1.7); endocarditis (1.8); and perioperative prophylaxis
(1.9).
DOSAGE AND ADMINISTRATION
For intravenous use only over approximately 30 minutes. (2)
THIS IS A PHARMACY BULK PACKAGE NOT FOR DIRECT INJECTION.
CEFAZOLIN FOR INJECTION USP, PHARMACY BULK PACKAGE BAG SMARTPAK
SHOULD NOT BE USED IN PATIENTS WHO
REQUIRE LESS THAN A 250 MG DOSE OF CEFAZOLIN (2.1)
Recommended Dosing Schedule in Adult Patients with CrCl Greater Than
or Equal to 55 mL/min (2.1)
SITE AND TYPE OF INFECTION
DO SE
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,
se ptice mia)*
1 gram to 1.5
grams
Every 6 hours
Perioperative prophylaxis
1 gram to 2
grams
½ to 1