CEFTRIAXONE- ceftriaxone sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ceftriaxone Sodium (UNII: 023Z5BR09K) (Ceftriaxone - UNII:75J73V1629)

Available from:

Sagent Pharmaceuticals

INN (International Name):

Ceftriaxone Sodium

Composition:

Ceftriaxone 10 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone 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. Ceftriaxone for Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused

Product summary:

Ceftriaxone for Injection, USP is supplied as a sterile crystalline powder in a Pharmacy Bulk Package as follows: Ceftriaxone for Injection, USP is also supplied as a sterile crystalline powder in glass vials as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
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CEFTRIAXONE FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
PREMIERProRx
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
ceftriaxone and other antibacterial drugs, ceftriaxone should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Ceftriaxone for Injection, USP is a sterile, semisynthetic,
broad-spectrum cephalosporin
antibiotic for intravenous or intramuscular administration.
Ceftriaxone sodium is
(6_R_,7_R_)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-
5,6-dioxo-_as_-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
acid, 7 -(_Z_)-(_O_-methyloxime), disodium salt, sesquaterhydrate.
The chemical formula of ceftriaxone sodium is C
H
N Na O S •3.5H O. It has a
calculated molecular weight of 661.60 and the following structural
formula:
Ceftriaxone for Injection, USP is a white to yellowish-orange
crystalline powder which is
readily soluble in water, sparingly soluble in methanol and very
slightly soluble in ethanol.
The pH of a 1% aqueous solution is approximately 6.7. The color of
Ceftriaxone for
Injection, USP solutions ranges from light yellow to amber, depending
on the length of
storage, concentration and diluent used.
Each Pharmacy Bulk Package is supplied as a dry powder in bottles
containing sterile
ceftriaxone sodium, USP equivalent to 10 grams of ceftriaxone and is
intended for
intravenous infusion only. Ceftriaxone for Injection, USP contains
approximately 83 mg
(3.6 mEq) of sodium per gram of ceftriaxone activity.
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
program and are restricted to the preparation of admixtures for
intravenous infusion.
FURTHER DILUTION IS REQUIRED BEFORE USE (see