CEFTRIAXONE injection, powder, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ceftriaxone sodium (UNII: 023Z5BR09K) (ceftriaxone - UNII:75J73V1629)

Διαθέσιμο από:

Sagent Pharmaceuticals

INN (Διεθνής Όνομα):

ceftriaxone sodium

Σύνθεση:

ceftriaxone 500 mg

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Ceftriaxone for Injection, USP is supplied as a sterile crystalline powder in glass vials as follows: Ceftriaxone for Injection, USP is also supplied as a sterile crystalline powder in a Pharmacy Bulk Package as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CEFTRIAXONE- CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
CEFTRIAXONE FOR INJECTION, USP
PREMIERProRx
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
ceftriaxone and other antibacterial drugs, ceftriaxone 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 661.60 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.
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 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
®
2
18
16
8
2
7 3
2
IV doses were infused at a constant rate over 30 minutes.
ND = Not determined.
Dose/Route
Average Plasma Concentrations (mcg/mL)
0.5 hr
1 hr
2 hr
4 hr
6 hr
8