CEFOXITIN injection, powder, for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

CEFOXITIN SODIUM (UNII: Q68050H03T) (CEFOXITIN - UNII:6OEV9DX57Y)

Saatavilla:

Hikma Pharmaceuticals USA Inc.

INN (Kansainvälinen yleisnimi):

CEFOXITIN SODIUM

Koostumus:

CEFOXITIN SODIUM 1 g in 10 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli, Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, Peptostreptococcus species and Streptococcus agalactiae. Cefoxitin for Injection, USP like cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when Cefoxitin for Injection, USP is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (5) Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase­-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis. (6) Bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains). (7) Skin and skin structure infections caused by Staphylococcus aureus (including penicillinase­-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes and other streptococci (excluding enterococci e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Escherichia coli, Proteus mirabilis, Klebsiella species, Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, and Peptostreptococcus species. Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to cefoxitin. Therapy may be started while awaiting the results of these studies. In randomized comparative studies, cefoxitin and cephalothin were comparably safe and effective in the management of infections caused by gram-positive cocci and gram-negative rods susceptible to the cephalosporins. Cefoxitin Injection, USP has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases. Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to cefoxitin. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with Cefoxitin Injection, USP. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with Cefoxitin Injection, USP. Cefoxitin for Injection, USP is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate treatment may be instituted. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefoxitin for injection 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 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. Cefoxitin for injection is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.

Tuoteyhteenveto:

Cefoxitin for Injection, USP is a dry white to off-white powder supplied in Pharmacy Bulk Package bottle. Each Pharmacy Bulk Package bottle contains cefoxitin sodium as follows: Cefoxitin for Injection, USP 10 g, Pharmacy Bulk Package - (10 gram cefoxitin equivalent)    NDC 0143-9876-10 cartons of 10 pharmacy bulk packages Cefoxitin for Injection in the dry state should be stored between 2º to 25°C (36º 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
CEFOXITIN FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
RX ONLY
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 is a semi-synthetic, broad-spectrum cepha
antibiotic sealed
under nitrogen for intravenous administration. It is derived from
cephamycin C, which is
produced by _Streptomyces lactamdurans. _Its chemical name is sodium
(6R,7S)-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 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 7.0.
Each Pharmacy Bulk Package Bottle of Cefoxitin for Injection, USP
contains sterile
cefoxitin sodium, USP equivalent to 10 grams of cefoxitin.
This Pharmacy Bulk Package Bottle is a container of sterile
preparation for intravenous
16
16
3
7 2
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. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE
USE. NOT
FOR DIRECT INFUSION.
CLINICAL PHARMACOLOGY
_CLINICAL PHARMACOLOGY_
Following an intravenous dose of 1 gram, serum concentrations were 110
mcg/mL at 5
minutes, declining to less than 1 mcg/mL at 4 hours. The half-life
after an intravenous
dose is 41 to 59 minutes. Approximately 85 percent of cefoxitin is
excreted unchanged
by the kidneys o