CEFTRIAXONE- ceftriaxone sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFTRIAXONE SODIUM (UNII: 023Z5BR09K) (CEFTRIAXONE - UNII:75J73V1629)

Available from:

Baxter Healthcare Corporation

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 1 g in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Before instituting treatment with Ceftriaxone 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 Injection, USP and other antibacterial drugs, Ceftriaxone 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 Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus

Product summary:

Ceftriaxone Injection, USP is supplied premixed as a frozen, iso-osmotic, sterile, nonpyrogenic solution of ceftriaxone sodium in a case of 24 x 50 mL single dose GALAXY containers (PL 2040 plastic). The following strengths are available: 1 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.9 gm Dextrose Hydrous, USP, added (NDC 0338-5002-41). 2 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.2 gm Dextrose Hydrous, USP, added (NDC 0338-5003-41). NOTE: Store Ceftriaxone Injection, USP in the frozen state at or below -20°C/-4°F. See DIRECTIONS FOR USE: Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE- CEFTRIAXONE SODIUM INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
CEFTRIAXONE INJECTION, USP (IN DEXTROSE)
IN GALAXY CONTAINER
(PL 2040 PLASTIC)
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Ceftriaxone Injection, USP and other antibacterial drugs, Ceftriaxone
Injection, USP
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
DESCRIPTION
Ceftriaxone Injection, USP is a sterile, semisynthetic, broad-spectrum
cephalosporin
antibiotic for intravenous 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 •7/2 H O. It has a
calculated molecular weight of 661.60 and the following structural
formula:
Ceftriaxone Sodium, 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.
Ceftriaxone Injection, USP contains approximately 83 mg (3.6 mEq) of
sodium per gram
of ceftriaxone activity.
Ceftriaxone Injection, USP is supplied as a frozen, iso-osmotic,
sterile, nonpyrogenic
solution premixed in a dextrose diluent. Dextrose, USP has been added
to adjust the
osmolality (approximately 1.9 g and 1.2 g as dextrose hydrous to the 1
g and 2 g
dosages, respectively). The pH may be adjusted with sodium hydroxide
and/or
hydrochloric acid. Solutions of premixed Ceftriaxone Injection, USP
may range from light
yellow to amber in color. After thawing, the solution is intended for
intravenous use. The
pH of thawed solutions may range from 6.0 to 8.0. See HOW SUPPLIED for
package
description.
The plastic container for the frozen solution is fabricated from a
specially designed
²
18
16
8
2
7 3
2
multilayer plastic,