CEFOTETAN - cefotetan disodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFOTETAN DISODIUM (UNII: 0GXP746VXB) (CEFOTETAN - UNII:48SPP0PA9Q)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotetan and other antibacterial drugs, cefotetan 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. Cefotetan for Injection, USP is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms: Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae ), Proteus mirabilis and Proteus spp (which may include the organisms now called Proteus vulgaris , Providencia rettgeri , and Morganella morganii ). Lower Respiratory Tract Infections caused by Streptococcus pneumoniae , Staphyloco

Product summary:

Cefotetan for Injection,  USP, in the Pharmacy Bulk Package, is a dry, white to pale yellow powder supplied in a Pharmacy Bulk Package containing cefotetan disodium equivalent to 10 g cefotetan activity for intravenous administration as follows: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].  PROTECT FROM LIGHT. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFOTETAN - CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
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CEFOTETAN FOR INJECTION, USP
Rx only
FOR INTRAVENOUS USE ONLY
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefotetan and
other antibacterial drugs, cefotetan should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION:
Cefotetan for Injection, USP, as cefotetan disodium, is a sterile,
semisynthetic, broad-spectrum, beta-
lactamase resistant, cephalosporin (cephamycin) antibiotic for
parenteral administration. It is the
disodium salt of
[6_R_-(6α,7α)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-
yl]carbonyl]amino]-7-methoxy-3-[[(1-methyl-1_H_-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Structural formula:
Cefotetan for Injection, USP is supplied in a Pharmacy Bulk Package
containing 80 mg (3.5 mEq) of
sodium per gram of cefotetan activity. It is a white to pale yellow
powder which is very soluble in
water. Reconstituted solutions of Cefotetan for Injection, USP are
intended for intravenous
administration. The solution varies from colorless to yellow depending
on the concentration. The pH
of freshly reconstituted solutions is usually between 4.5 to 6.5.
Each Cefotetan for Injection Pharmacy Bulk Package bottle is supplied
as a dry powder containing
sterile cefotetan disodium equivalent to 10 grams cefotetan and is
intended for intravenous use only.
Cefotetan for Injection, USP contains 80 mg (3.5 mEq) of sodium per
gram of cefotetan activity.
A Pharmacy Bulk Package is a container of sterile preparation for
parenteral use that contains many
single doses. The contents are intended for use in a pharmacy
admixture program and are restricted to
the preparation of admixtures for intravenous infusion. FURTHER
DILUTION IS REQUIRED
BEFORE USE (see DOSAGE AND ADMINISTRATION, and DIRECTIONS FOR PROPER
USE
OF PHARM