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:

Sandoz Inc

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, 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: Caused by Streptococcus pneumoniae , Staphylococcus aureus, Ha

Product summary:

Ceftriaxone for injection, USP sterile powder is available in Pharmacy Bulk Package bottle containing 10 g equivalent of ceftriaxone. Box of 1 (0781-3210-46). Other Size Packages Available: Ceftriaxone for Injection, USP is also supplied as a sterile crystalline powder in glass vials as follows: Vials containing 250 mg equivalent to ceftriaxone. Package of 10 (0781-3206-95). Vials containing 500 mg equivalent to ceftriaxone. Package of 10 (0781-3207-95). Vials containing 1 g equivalent to ceftriaxone. Package of 10 (0781-3208-95). Vials containing 2 g equivalent to ceftriaxone. Package of 10 (0781-3209-95). Vials containing 250 mg equivalent to ceftriaxone. Package of 1 (0781-3206-85). Vials containing 500 mg equivalent to ceftriaxone. Package of 1 (0781-3207-85). Vials containing 1 g equivalent to ceftriaxone. Package of 1 (0781-3208-85). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE SODIUM- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
SANDOZ INC
----------
CEFTRIAXONE FOR INJECTION, USP
RX ONLY
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
ceftriaxone for injection, and other antibacterial drugs, ceftriaxone
for injection 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 sodium is a white to yellowish 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 sodium
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 Pharmacy
Bulk Package
bottles containing sterile ceftriaxone sodium, USP equivalent to 10
grams of ceftriaxone
and is intended for intravenous infusion only. Ceftriaxone sodium
contains
2
18
16
8
2
7 3
2
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 BEFO