CEFOXITIN- cefoxitin injection, powder, for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Apotex Corporation

INN (International Nazwa):

CEFOXITIN SODIUM

Skład:

CEFOXITIN 1 g

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Treatment 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. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with cefoxitin. Cefoxitin for injection 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 i

Podsumowanie produktu:

Sterile cefoxitin for injection is a dry white to off-white powder supplied in vials containing cefoxitin sodium as follows: Each vial contains cefoxitin sodium equivalent to 1 gram or 2 grams cefoxitin: Also available as a Pharmacy Bulk Package containing cefoxitin sodium equivalent to 10 grams cefoxitin. Special storage instructions Cefoxitin for injection in the dry state should be stored 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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
APOTEX CORPORATION
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CEFOXITIN FOR INJECTION, USP
ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefoxitin for
injection and other antibacterial drugs, cefoxitin for injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cefoxitin for injection 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,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 contains approximately 53.8 mg (2.3
milliequivalents) of sodium per gram of
cefoxitin activity. Solutions of cefoxitin for injection range from
colorless to light amber in color. The
pH of freshly constituted solutions usually ranges from 4.2 to 7.
Each conventional vial contains sterile cefoxitin sodium, USP
equivalent to 1 or 2 g cefoxitin.
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 over a 6 hour period,
resulting in high urinary concentrations. Probenecid slows tubular
excretion and produces higher serum
levels and increases the duration of measurable serum concentrations.
Cefoxitin passes into pleural and joint fluids and is detectable in
antibacterial concentrations in bile.
In a published study of geriatric patients ranging in age from 64 to
88 years with normal renal function
for their age (creatinine clearance ranging from 31.5 to 174.0
mL/min), the half-life for c