CEFOXITIN injection, powder, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Cefoxitin Sodium (UNII: Q68050H03T) (Cefoxitin - UNII:6OEV9DX57Y)

Dostupné z:

Sagent Pharmaceuticals

INN (Medzinárodný Name):

Cefoxitin Sodium

Zloženie:

Cefoxitin 10 g

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Cefoxitin for Injection, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections , including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli , Klebsiella species, Haemophilus influenzae, and Bacteroides species. (2) Urinary tract infections caused by Escherichia coli , Klebsiella species, Proteus mirabilis , Morganella morganii , Proteus vulgaris and Providencia species (including P. rettgeri ). (3) Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli , Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species. (4) Gynecological infections, including endometritis, pelvi

Prehľad produktov:

Cefoxitin for Injection, USP is a dry white to off-white powder supplied in pharmacy bulk package bottles containing cefoxitin sodium as follows: Cefoxitin for Injection, USP is also available in conventional vials containing cefoxitin sodium as follows: Store dry powder between 2° to 25°C (36° to 77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
CEFOXITIN FOR INJECTION, USP
(FOR INTRAVENOUS USE)
PHARMACY BULK PACKAGE –
NOT FOR DIRECT INFUSION
SAGENT
Rx only
RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefoxitin for
Injection, USP and other antibacterial drugs, Cefoxitin for Injection,
USP should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Cefoxitin for Injection, USP contains cefoxitin sodium a
semi-synthetic, broad-spectrum cephalosporin
antibiotic for parenteral administration. It is derived from
cephalosporin C, which is produced by
_Cephalosporium Acremonium_. Its chemical name is sodium (6_R_,
7_S_)-3-(hydroxymethyl)-7-methoxy-8-
oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo
[4.2.0]oct-2-ene-2-carboxylate carbamate (ester).
The molecular formula is C
H N NaO S , and the structural formula is:
Cefoxitin for Injection, USP is supplied as a dry powder in vials and
contains approximately 53.8 mg
(2.3 milliequivalents) of sodium per gram of cefoxitin activity.
Solutions of Cefoxitin for Injection, USP
range from colorless to light amber in color. The pH of freshly
constituted solutions usually ranges
from 4.2 to 7.
Each pharmacy bulk package bottle contains sterile cefoxitin sodium,
USP equivalent to 10 g of
cefoxitin and is intended for intravenous infusion only. A pharmacy
bulk package is a container of a
sterile preparation for parenteral 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. RECONSTITUTED BULK
SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK
SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
Following an intravenous