CEFTRIAXONE SODIUM injection powder for solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

CEFTRIAXONE SODIUM (UNII: 023Z5BR09K) (CEFTRIAXONE - UNII:75J73V1629)

Saadav alates:

Cardinal Health

INN (Rahvusvaheline Nimetus):

CEFTRIAXONE SODIUM

Koostis:

CEFTRIAXONE 2 g

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

CEFTRIAXONE SODIUM- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH
----------
CEFTRIAXONE FOR INJECTION, USP
ADD-VANTAGE® VIALS
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 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.
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 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
ADMINIS TRATION
DOS E/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 gm IV
82
59
48
37
29
23
15
10
5
0.5 gm IM
2
18
16
8
2
7
3
2
*
*
250 mg/mL
22
33
38