CEFTRIAXONE- ceftriaxone 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:

Fresenius Kabi USA, LLC

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE SODIUM 10 g

Administration route:

INTRAVENOUS

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 and other antibacterial drugs, ceftriaxone 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 is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilu

Product summary:

Ceftriaxone for Injection, USP in a Pharmacy Bulk Package, NOT FOR DIRECT INFUSION, containing 10 gram equivalent of ceftriaxone is available as: Product No. NDC No. Strength 304861 63323-348-61 10 gram 100 mL vial, packaged individually. Vial stoppers do not contain natural rubber latex. Ceftriaxone for Injection, USP is also supplied as a sterile crystalline powder in glass vials: Product No. NDC No. Strength 304410 63323-344-10 250 mg 25 vials per carton. 304510 63323-345-10 500 mg 25 vials per carton. 304610 63323-346-10 1 gram 25 vials per carton. 304720 63323-347-20 2 grams 10 vials per carton. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE- CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
CEFTRIAXONE FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
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 structural formula of ceftriaxone sodium is:
Ceftriaxone for injection 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 Pharmacy Bulk Package is supplied as a dry powder in vials
containing sterile ceftriaxone sodium
equivalent to 10 grams of ceftriaxone and is intended for intravenous
infusion only. Ceftriaxone for
injection contains approximately 83 mg (3.6 mEq) of sodium per gram of
ceftriaxone activity.
A Pharmacy Bulk Package is a container of a sterile preparation for
parenteral use that contains many
single doses. The contents are intended for use in a pharmacy
admixture program and are restricted to
the preparation of admixtures for intravenous infusion. (See DOSAGE
AND ADMINISTRATION, and
DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE).
CLINICAL PHARMACOLOGY
Average plasma concentrations of ceftriaxone following a single
30-minute i