CEFAZOLIN- cefazolin sodium powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T)

Available from:

Cardinal Health

INN (International Name):

CEFAZOLIN SODIUM

Composition:

CEFAZOLIN 1 g in 3 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP for Injection and other antibacterial drugs, Cefazolin for Injection, USP 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, USP 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 eradica

Product summary:

Cefazolin for Injection, USP  Product No.  NDC No.     Cefazolin for Injection, USP   23710  55154-9559-5  1 gram  Available overbagged with 5 vials per bag, NDC 55154-9559-5 Cefazolin for Injection, USP, is supplied in 500 mg and 1 gram vials. Each vial contains cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin and is packaged 25 per tray. Preservative Free. As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Before reconstitution protect from light and store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFAZOLIN- CEFAZOLIN SODIUM POWDER, FOR SOLUTION
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFAZOLIN FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFAZOLIN FOR
INJECTION.
CEFAZOLIN FOR INJECTION, USP FOR INTRAMUSCULAR OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1973
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF CEFAZOLIN FOR
INJECTION AND OTHER ANTIBACTERIAL DRUGS, CEFAZOLIN FOR INJECTION
SHOULD BE USED ONLY TO TREAT OR PREVENT
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY
BACTERIA.
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 aproximately 30 minutes. (2)
RECOMMENDED DOSING SCHEDULE IN ADULT PATIENTS WITH CRCL GREATER THAN
OR EQUAL TO 55 ML/MIN. (2.1)
SITE AND 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,
se ptice mia)*
1 gram to 1.5 grams
every 6 hours
Perioperative prophylaxis
1 gram to 2 grams
½ to 1 hour prior to start of surgery
500 mg to 1 gram
during surgery for lengthy procedures
500 mg to 1 gram
every 6 to 8 hours for 24 hours
postope rative ly
* In rare instances, doses of up to 12 grams of cefazolin per day have
been used.
DOSAGE FORMS AND S