CEFTRIAXONE injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lupin Pharmaceuticals, Inc.

INN (International Name):

CEFTRIAXONE SODIUM

Sammensetning:

CEFTRIAXONE 250 mg

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 by Streptococcus pneumo

Produkt oppsummering:

Ceftriaxone for injection USP is supplied as a sterile crystalline powder in glass vials. The following packages are available: Vials containing 250 mg equivalent of ceftriaxone. Box of 1 (NDC 68180-611-01) and box of 10 (NDC 68180-611-10). Vials containing 500 mg equivalent of ceftriaxone. Box of 1 (NDC 68180-622-01) and box of 10 (NDC 68180-622-10). Vials containing 1 g equivalent of ceftriaxone. Box of 1 (NDC 68180-633-01) and box of 10 (NDC 68180-633-10). Vials containing 2 g equivalent of ceftriaxone. Box of 10 (NDC 68180-644-10). NOTE: Ceftriaxone for injection USP sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CEFTRIAXONE - CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION
LUPIN PHARMACEUTICALS, INC.
----------
CEFTRIAXONE FOR INJECTION USP, 250 MG, 500 MG, 1 G AND 2 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 USP 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-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 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 solutions ranges from light yellow to amber, depending on
the length of
storage, concentration and diluent used.
Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1
gram or 2 grams
of ceftriaxone activity. 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
ND = Not determined