CEFTRIAXONE- ceftriaxone 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:

Apotex Corporation

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 250 mg

Administration route:

INTRAMUSCULAR

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 b

Product summary:

Ceftriaxone for Injection, USP is supplied as a sterile crystalline powder in glass vials and piggyback bottles. The following packages are available: Piggyback bottles containing Storage Prior to Reconstitution: 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- CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION
APOTEX CORPORATION
----------
CEFTRIAXONE FOR INJECTION, USP
RX ONLY
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 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 661.59 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 vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1
gram or 2 grams of ceftriaxone
activity. Ceftriaxone for Injection, USP 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 gm dose and intramuscular (IM) administration of a
single 0.5 (250 mg/mL or 350 mg/mL
concentrations) or 1 gm dose in healthy subjects are presented in
Table 1.
TABLE 1. CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE
ADMINISTRATION
DOS E/ROUTE
AVERAGE PLASMA CONCENTRATIONS (