CEFAZOLIN injection, powder, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Medical Purchasing Solutions, LLC

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP 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 serious infections due to susceptible organisms. Respiratory tract infections due to Streptococcus pneumoniae , Klebsiella species, H. influenzae , Staphylococcus aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be the dru

leaflet_short:

Cefazolin for Injection, USP is supplied as a sterile white or off-white powder or crystalline powder. Each vial contains cefazolin sodium equivalent to 1 gram of cefazolin. Unit of Sale Strength Each NDC 60505-6142-5 Carton containing 25 1 Gram NDC 60505-6142-0 Vial As with other cephalosporins, cefazolin 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].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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, FOR 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)
Perioperative prophylaxis. ( 1.9)
DOSAGE AND ADMINISTRATION
For intravenous or intramuscular use. ( 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, septicemia)
1 gram to 1.5 grams
every 6 hours
DOSAGE FORMS AND STRENGTHS
1 g per vial.( 3)
CONTRAINDICATIONS
Hypersensitivity to cefazolin or other cephalosporin class
antibacterial drugs, penicillins, or other beta-
lactams. ( 4.1)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Cross-hypersensitivity may occur in up to
10% of patients with a history