CEFAZOLIN- cefazolin sodium injection, powder, for solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

General Injectables & Vaccines, Inc

INN (nume internaţional):

Cefazolin Sodium

Compoziție:

Cefazolin 1 g in 3 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

To reduce the development of drug-resistant bacteria and maintain the effectivness 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 infections when caused by susceptible bacteria. 1.1 Respiratory Tract Infections Respiratory tract infections due to Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes. Injectable benzatine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including prophylaxis of rheumatic fever. Cefazolin is effective i

Rezumat produs:

Cefazolin for Injection, USP is supplied as a sterile, white to off-white crystalline powder. Each vial contains cefazolin sodium equivalent to 1 gram of cefazolin. 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].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, POWDER, FOR SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
CEFAZOLIN FOR INJECTION USP 1 GRAM
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, 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)
Billiary 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)
*In rare instances, doses of up to 12 grams of cefazolin per day have
been used.
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 of penicillin allergy. If an allergic reaction occurs,
discontinue the drug. (5.1)
Use in Patients with Renal Impairment: Dose adjustment required for
patients with CrCl less than 55
mL/min. (5.2)
_Clostridium difficile-_associated Diarrhea: May range from mild
diarrhea to fatal colitis. Evaluate if
diarrhea occurs. (5.3)
ADVERSE REACTIONS
Most common Adverse Reactions: Gastrointestin