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:

Apotex Corp.

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 250 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 b

Product summary:

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. Package of 10 (NDC 60505-6151-1). Vials containing 500 mg equivalent of ceftriaxone. Package of 10 (NDC 60505-6152-1). Vials containing 1 g equivalent of ceftriaxone. Package of 10 (NDC 60505-6148-4). Vials containing 2 g equivalent of ceftriaxone. Package of 10 (NDC 60505-6149-4). Vials containing 250 mg equivalent of ceftriaxone. Package of 1 (NDC 60505-6151-4). Vials containing 500 mg equivalent of ceftriaxone. Package of 1 (NDC 60505-6152-4). Vials containing 1 g equivalent of ceftriaxone. Package of 1 (NDC 60505-6148-0). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE SODIUM- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
APOTEX CORP.
----------
CEFTRIAXONE FOR INJECTION, USP
RX ONLY
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 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, USP 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 g or 2 g 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.
2
18
16
8
2
7
3
2
TABLE 1 CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE
ADMINISTRATION
DOSE/ROUTE
AVERAGE PLASMA CONCENTRATIO