CEFTRIAXONE SODIUM injection, powder, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Rebel Distributors Corp

INN (الاسم الدولي):

CEFTRIAXONE SODIUM

تركيب:

CEFTRIAXONE 500 mg

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 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 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 sodium is indicated for the treatment of the following infections when caused by susceptible organisms: Lower Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococc

ملخص المنتج:

Ceftriaxone sodium is supplied as a sterile crystalline powder in glass vials and piggyback bottles. The following packages are available: Vials containing 500 mg equivalent of ceftriaxone. Box of 10 (NDC 21695-202-10) .  Vials containing 1 gm equivalent of ceftriaxone. Box of 1 (NDC 21695-352-01). Vials containing 1 gm equivalent of ceftriaxone. Box of 10 (NDC 21695-352-10). NOTE: Ceftriaxone sodium sterile powder should be stored at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature ] and protected from light.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CEFTRIAXONE SODIUM- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
REBEL DISTRIBUTORS CORP
----------
CEFTRIAXONE SODIUM
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 sodium 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 sodium 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 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 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 gm IV
82
59
48
37
29
23
15
10
5
0.5 gm IM
250 mg/mL
22
33
38
35
30
26
16
ND
5
0.5 gm IM
350 mg/mL
20
32
38
3