CEFTRIAXONE sodium injection powder for solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

AGILA SPECIALTIES PRIVATE LIMITED

INN (Internationale Bezeichnung):

CEFTRIAXONE SODIUM

Zusammensetzung:

CEFTRIAXONE 10 g in 100 mL

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CEFTRIAXONE- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
AGILA SPECIALTIES PRIVATE LIMITED
----------
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 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 white or 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 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 g of ceftriaxone and
is intended for intravenous
infusion only.
Ceftriaxone sodium, USP contains approximately 83 mg (3.6 mEq) of
sodium per gram of ceftriaxone
activity.
A Pharmacy Bulk Package is a container of 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 DO