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:

A-S Medication Solutions

Administration route:

INTRAMUSCULAR

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:

Product: 50090-0944 NDC: 50090-0944-0 1 INJECTION, POWDER, FOR SOLUTION in a VIAL, SINGLE-USE / 10 in a CARTON

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE SODIUM- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
A-S MEDICATION SOLUTIONS
----------
CEFTRIAXONE FOR INJECTION, USP
RX ONLY
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 vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1
gram or 2 grams
of ceftriaxone activity. Ceftriaxone sodium contains approximately 83
mg (3.6 mEq) of
sodium per gram of ceftriaxone activity.
CLINICAL PHARMACOLOGY
2
18
16
8
2
7 3
2
Average plasma concentrations of ceftriaxone following a single
30-minute intravenous
(IV) infusion of a 0.5, 1 or 2 g dose and intramuscular (IM)
administration of a single 0.5
(250 mg/mL or 350 mg/mL concentrations) or 1 g dose in healthy
subjects are
presented in TABLE 1.
TABLE 1. CEFTRIAXONE PLASMA CONCENTRATIONS AFTER
SINGLE DOSE ADMINISTRATION
AVERAGE PLASMA CONCENTRATIONS (MCG/ML)
DOSE/ROUTE 0.5
HOUR