CEFTAZIDIME injection, powder, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ceftazidime (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301)

Доступна с:

Sagent Pharmaceuticals

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Ceftazidime for injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: - Lower Respiratory Tract Infections , including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin-susceptible strains). - Skin and Skin-Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci). - Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli. - Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae , Escherichia coli , Serratia spp., Streptococcus pneumoniae , and Staphylococcus aureus (methicillin-susceptible strains). - Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible strains). - Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli. - Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many strains of Bacteroides fragilis are resistant). - Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae . Ceftazidime for injection, USP may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibacterial drugs have been used. Ceftazidime for injection, USP may also be used concomitantly with other antibacterial drugs, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibacterial drugs should be followed. The dose depends on the severity of the infection and the patient's condition. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftazidime for injection, USP and other antibacterial drugs, ceftazidime for injection, USP should be used only to treat 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. Ceftazidime for injection is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibacterial drugs. Ceftazidime for Injection, USP Instructions for Constitution Pharmacy Bulk Package: 6 g - Insert the syringe needle through the vial closure and inject 26 mL of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle. - Shake to dissolve; a clear solution containing approximately 1 g of ceftazidime activity per 5 mL will be obtained in 1 to 2 minutes. - Insert a gas-relief needle through the vial closure to relieve the internal pressure. Remove the gas-relief needle before extracting any solution. Note: To preserve product sterility, it is important that a gas-relief needle is not inserted through the vial closure before the product has dissolved. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Brazil ©2020 Sagent Pharmaceuticals, Inc. Revised: June 2020 SAGENT Pharmaceuticals®

Обзор продуктов:

Ceftazidime for injection, USP in the dry state should be stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] and protected from light. Ceftazidime for Injection, USP is a white to cream-colored crystalline powder supplied in Pharmacy Bulk Package Bottles as follows: *Equivalent to anhydrous ceftazidime. Sterile, Nonpyrogenic, Preservative-free The container closure is not made with natural rubber latex.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CEFTAZIDIME- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
CEFTAZIDIME FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
SAGENT
Rx only
FOR INTRAVENOUS USE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
ceftazidime for injection and other antibacterial drugs, ceftazidime
for injection should be
used only to treat infections that are proven or strongly suspected to
be caused by
bacteria.
DESCRIPTION
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam
antibacterial drug for
parenteral administration. It is the pentahydrate of pyridinium,
1-[[7-[[(2-amino-4-
thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt,
[6R-[6α,7β(Z)]]. It has the
following structural formula:
The molecular formula is C
H
N O S •5H O, representing a molecular weight of
636.65.
Ceftazidime for injection, USP is a sterile, dry-powdered mixture of
ceftazidime
pentahydrate and sodium carbonate. The sodium carbonate at a
concentration of 118
mg/g of ceftazidime activity has been admixed to facilitate
dissolution. The total sodium
content of the mixture is approximately 54 mg (2.3 mEq)/g of
ceftazidime activity.
Ceftazidime for injection, USP is a white to cream-colored crystalline
powder. Solutions
of ceftazidime for injection, USP range in color from light yellow to
amber, depending on
the diluent and volume used. The pH of freshly constituted solutions
usually ranges from
5 to 8.
®
22
22
6
7 2
2
Ceftazidime for injection, USP in sterile crystalline form is supplied
in 6 gram Pharmacy
Bulk Package bottles equivalent to 6 grams of anhydrous ceftazidime.
The Pharmacy Bulk Package bottle contains 708 mg of sodium carbonate.
The sodium
content is approximately 54 mg (2.3 mEq) per gram of ceftazidime.
The 6 g Pharmacy Bulk Package bottle is a container of sterile
preparation for parenteral
use that contains many single doses. The contents are intended for use
i