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:

Lupin Pharmaceuticals, Inc.

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 10 g

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 by S

Product summary:

Ceftriaxone for injection, USP sterile powder is available in a Pharmacy Bulk Package, NOT FOR DIRECT ADMINISTRATION, containing 10 g equivalent of ceftriaxone.  Box of 1 (NDC 68180-655-01). 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
LUPIN PHARMACEUTICALS, INC.
----------
CEFTRIAXONE FOR INJECTION USP
10 G
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
(_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,
72-(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 sodium 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 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 vials
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 AND ADMINISTRATION, and DIRECTIONS FOR PROPER
USE OF_
_PHARMACY B