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:

BAXTER HEALTHCARE CORPORATION

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE SODIUM 1 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
CEFTRIAXONE FOR INJECTION USP 1 G
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ceftriaxone
sodium 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 is a sterile, semisynthetic, broad-spectrum
cephalosporin antibiotic for
intravenous or intramuscular administration. Ceftriaxone sodium is
(_6R_,_7R_)-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-l-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid, 7
-(Z)-(_O-methyloxime_), disodium salt,
sesquaterhydrate.
The molecular formula of ceftriaxone sodium is C
H N Na O S . 3.5 H O. It has a calculated
molecular weight of 661.60 and the following structural formula:
Ceftriaxone for injection 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
solutions ranges from light yellow
to amber, depending on the length of storage, concentration and
diluent used.
Ceftriaxone for injection 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
Dose/ Route
Average Plasma Concentrations (mcg/mL)
0.5 hr
1 hr
2 hr
4 hr
6 hr
8 hr
12 hr
16 hr
24 hr
0.5 g IV*
82
59
48
37
29
23
15
10
5
0.5 g IM
250 mg/ mL
22
33
38
35
30