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

INN (International Name):

CEFOTETAN DISODIUM

Composition:

CEFOTETAN 1 g in 10 mL

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 , Proteus vulgaris , Providencia rettgeri , and Morganella morganii ). Lower Respiratory Tract Infections caused by Streptococcus pneumoniae , Staphylococcus aureus (methicillin-susceptible), Haemophilus influenzae

Product summary:

Cefotetan for Injection, USP is a dry, white to pale yellow powder supplied in vials containing cefotetan disodium equivalent to 1 g and 2 g cefotetan activity for intravenous and intramuscular administration.  The vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  PROTECT FROM LIGHT . The container closure is not made with natural rubber latex. The following packages are available: The brand names mentioned in this document are the trademarks of their respective owners.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFOTETAN - CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
CEFOTETAN FOR INJECTION, USP
Rx only
FOR INTRAVENOUS OR INTRAMUSCULAR USE
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) antibacterial 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 vials 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
and intramuscular 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.
Cefotetan for Injection, USP is available in two vial strengths. Each
1 gram vial contains cefotetan
disodium equivalent to 1 gram cefotetan activity. Each 2 gram vial
contains cefotetan disodium
equivalent to 2 grams cefotetan activity.
CLINICAL PHARMACOLOGY:
High plasma levels of cefotetan are attained after intravenous and
intramuscular administration of single
doses to normal volunteers.
PLASMA CONCENTRATIONS AFTER 1 GRAM INTRAVENOUS OR INTRAMUSCULAR
DOSE MEAN PLASMA CONCENTRATION (MCG/ML)
_ _ TIME AFTER INJECTION
ROUTE
15 MIN
30 MIN
1 H
2 H
4 H
8 H
12 H
IV
92
158
103
72
42
18
9
A
IM
34
56
71
68
47
20
9
30-minute infusion
PLASMA CONCENTRATIONS AFTER 2 GRAM INTRAVENOUS OR INTRAMUSCULA