CEFTRIAXONE injection, powder, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

LUPIN LIMITED

INN (International Name):

CEFTRIAXONE SODIUM

Sammensætning:

CEFTRIAXONE 250 mg

Indgivelsesvej:

INTRAMUSCULAR

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 oversigt:

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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CEFTRIAXONE- CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION
LUPIN LIMITED
----------
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
ND = Not determined.
IV doses were infused at a cons