CEFAZOLIN- cefazolin sodium injection, powder, for solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

cefazolin sodium (UNII: P380M0454Z) (cefazolin - UNII:IHS69L0Y4T)

Inapatikana kutoka:

Sagent Pharmaceuticals

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Cefazolin for Injection, USP is indicated for 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 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 IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.

Bidhaa muhtasari:

Cefazolin for Injection, USP, containing cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin, is supplied as follows: Cefazolin for Injection, USP is also available in a 10 gram Pharmacy Bulk Package. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin and is supplied as follows: 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, store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Italy ©2020 Sagent Pharmaceuticals, Inc. Revised: July 2020 SAGENT Pharmaceuticals®

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
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CEFAZOLIN FOR INJECTION, USP
SAGENT
Rx only
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 pH of the reconstituted solution is between 4 and 6.
Cefazolin for Injection, USP is a sterile white to cream powder
supplied in vials. Each vial
contains, cefazolin sodium equivalent to 500 mg or 1 gram of
cefazolin.
The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin
sodium or
approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium.
The color of Cefazolin for Injection, USP solutions may range from
pale yellow to yellow
without a change in potency.
Cefazolin for Injection, USP is to be administered by intramuscular or
intravenous
routes.
CLINICAL PHARMACOLOGY
After intramuscular administration of Cefazolin for Injection 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
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 is approximately 1.8
hours following IV
administration and approximately 2 hours following IM administration.
In a study (using normal volunteers) of constant intravenous infusion
wit