CEFTRIAXONE SODIUM- 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:

Cardinal Health

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 1 g

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 is supplied as a sterile crystalline powder in glass vials. The following packages are available: Vials containing 1 g equivalent to ceftriaxone are available overbagged with 5 vials per bag, NDC 55154-5446-5 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
CARDINAL HEALTH
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CEFTRIAXONE FOR INJECTION, USP
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
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)
DOS E/ROUTE
0.5 HR
1 HR
2 HR
4 HR
6 HR
8 HR
12 HR
16 H