CEFTRIAXONE SODIUM- 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:

Sandoz GmbH

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 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: Caused by Streptococcus pneumoniae , Staphylococcus aureus, Ha

Product summary:

Ceftriaxone for injection, USP sterile powder is available in Pharmacy Bulk Package bottle containing 10 g equivalent of ceftriaxone. Box of 1 (43858-635-00). Other Size Packages Available: Ceftriaxone for Injection, USP is also supplied as a sterile crystalline powder in glass vials as follows: Vials containing 250 mg equivalent to ceftriaxone. Package of 10 (43858-631-01). Vials containing 500 mg equivalent to ceftriaxone. Package of 10 (43858-632-01). Vials containing 1 g equivalent to ceftriaxone. Package of 10 (43858-633-01). Vials containing 2 g equivalent to ceftriaxone. Package of 10 (43858-634-01). Vials containing 250 mg equivalent to ceftriaxone. Package of 1 (43858-631-00). Vials containing 500 mg equivalent to ceftriaxone. Package of 1 (43858-632-00). Vials containing 1 g equivalent to ceftriaxone. Package of 1 (43858-633-00). 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
SANDOZ GMBH
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CEFTRIAXONE FOR INJECTION, USP
RX ONLY
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ceftriaxone for
injection, 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
(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 sodium is a white to yellowish 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 sodium 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 Pharmacy
Bulk Package bottles containing
sterile ceftriaxone sodium, USP equivalent to 10 grams of ceftriaxone
and is intended for intravenous
infusion only. Ceftriaxone sodium 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. FURTHER
DILUTION IS REQUIRED
BEFORE USE. (See DOSAGE