CEFAZOLIN injection, powder, for solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Hikma Pharmaceuticals USA Inc.

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections: due to S. penumoniae, 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. 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.

Огляд продуктів:

Cefazolin for Injection, USP, is supplied in 10 and 20 grams Pharmacy Bulk Package vials. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 or 20 grams of cefazolin, as follows: Cefazolin for Injection, USP Vial Size Packaged NDC No. 10 grams 100 mL Carton of 10 vials 0143-9983-03 20 grams 100 mL Carton of 10 vials 0143-9665-10 Also available as: Cefazolin for Injection, USP Vial Size Packaged NDC No. 500 mg 10 mL Carton of 25 vials 0143-9923-90 1 gram 10 mL Carton of 25 vials 0143-9924-90 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 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL) S.A. Estrada do Rio da Mó, nº8, 8A and 8B – Fervença 2705-906 Terrugem SNT PORTUGAL  Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: September 2020 PIN089-WES/7

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
CEFAZOLIN FOR INJECTION, USP
RX ONLY
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
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.
DESCRIPTION
Cefazolin for Injection, USP is a semi-synthetic cephalosporin for
parenteral
administration. It is the sodium salt of (6R,
7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-
yl)]thio]methyl]-8-oxo-7-[2(1H-tetrazol-1-yl)acetoamido]-5-thia-1-azabicyclo[4.2.0]oct-2-
ene-2-carboxylic acid.
The structural formula is as follows:
Cefazolin for Injection, USP is a white to cream sterile powder. The
color of Cefazolin for
Injection, USP solutions may range from pale yellow to yellow without
a change in
potency.
The pH ranges from 4.0 and 6.0 for a solution containing 100 mg of
cefazolin per mL.
Cefazolin for Injection, USP is supplied in 10 or 20 grams Pharmacy
Bulk Packages. Each
Pharmacy Bulk Package contains Cefazolin Sodium, USP equivalent to 10
or 20 grams of
cefazolin. The sodium content is approximately 48 mg (2.1 mEq) per
gram of cefazolin
sodium. It is to be administered by intravenous route.
A Pharmacy Bulk Package is a container of a sterile preparation for
intravenous use that
contains many single doses. The contents are intended for use in a
pharmacy admixture
service and are restricted to the preparation of admixtures for
intravenous infusion.
FURTHER DILUTION IS REQUIRED BEFORE USE.
CLINICAL PHARMACOLOGY
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 1 gram dose.
The serum half-life for Cefazolin for Injection is approximately 1.8
hours following
intravenous administration.
In a study (u