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:

Physicians Total Care, Inc.

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 250 mg

Administration route:

INTRAMUSCULAR

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 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

Product summary:

Ceftriaxone sodium is supplied as a sterile crystalline powder in glass vials. The following packages are available: Vials containing 250 mg equivalent of ceftriaxone. Box of 10      (NDC 54868-5589-0).  Vials containing 500 mg equivalent of ceftriaxone. Box of 10      (NDC 54868-5533-0).  NOTE: Ceftriaxone sodium sterile powder should be stored at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature ] and protected from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE SODIUM - CEFTRIAXONE SODIUM INJECTION, POWDER, FOR
SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
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 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