CEFAZOLIN injection, powder, for solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Apotex Corp.

INN (Isem Internazzjonali):

CEFAZOLIN SODIUM

Kompożizzjoni:

CEFAZOLIN 1 g

Rotta amministrattiva:

INTRAMUSCULAR

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species , H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci . Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci . Skin and Skin Structure Infections:  Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis,  Klebsiella species, and S. aureus. Bone and Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci . Septicemia:  Due to S. pneumoniae, S. aureus (penicillin-sensitive and penicillin-resistant), P. mirabilis, E. coli, and  Klebsiella species. Endocarditis:  Due to S. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci . Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection, USP may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection, USP should usually be discontinued within a 24-hour period after the surgical procedure.  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection, USP may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.) 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 CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.

Sommarju tal-prodott:

Each vial of Cefazolin for Injection, USP contains cefazolin sodium equivalent to 1 gram, 2 grams or 3 grams cefazolin. NDC 60505-6142-5, 1 gram, carton of 25 vials NDC 60505-6231-5, 2 grams, carton of 25 vials NDC 60505-6266-5, 3 grams, carton of 25 vials 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]. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. Manufactured by: Qilu Pharmaceutical Co., Ltd. High Tech Zone Jinan, 250101, China Manufactured for: Apotex Corp. Weston, Florida, USA 33326 Code number: 34040001011F Code number: 34160026811G

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
APOTEX CORP.
----------
CEFAZOLIN FOR INJECTION, USP
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
BACTERIA.
DESCRIPTION
Cefazolin for Injection, USP is a semi-synthetic cephalosporin for
parenteral
administration. It is the sodium salt of
3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-
8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo
[4.2.0]oct-2-ene-2-
carboxylic acid.
Structural Formula:
The sodium content is 48 mg (2 mEq sodium ion) per 1 gram of
cefazolin.
Cefazolin for Injection, USP is a sterile white or off-white powder or
crystalline powder
containing Cefazolin Sodium USP supplied in vials equivalent to 1 gram
2 grams or 3
grams of cefazolin.
CLINICAL PHARMACOLOGY
After intramuscular administration of Cefazolin for Injection, USP to
normal volunteers,
the mean serum concentrations were 37 mcg/mL at 1 hour and 3 mcg/mL at
8 hours
following a 500-mg dose, and 64 mcg/mL at 1 hour and 7 mcg/mL at 8
hours following a
1-gram dose.
Studies have shown that following intravenous administration of
Cefazolin for Injection,
USP to normal volunteers, mean serum concentrations peaked at
approximately 185
mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1-gram dose.
The serum half-life for Cefazolin for Injection, USP is approximately
1.8 hours following
IV administration and approximately 2.0 hours following IM
administration.
In a study (using normal volunteers) of constant intravenous infusion
with dosages of
3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2
hours
(approximately 100 mg), Cefazolin for Injection, USP produced a steady
serum level at
the third hour of approximately 28 mcg/mL.
Studies in patients hospitalized with infections indicate that
Cefazolin for Injection,
USP produces mea