CEFTRIAXONE- 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:

Samson Medical Technologies, LLC

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 100 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 bacteria: Lower respiratory tract infections caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens . Skin and skin structure infections caused by Staphylococcus aureus, Staphylococcus epi

Product summary:

Ceftriaxone for Injection, USP is available in the following SmartPak® Pharmacy Bulk Package bags:    100 grams* One Pharmacy Bulk Package bag Product No. 6100 NDC 66288-6100-1.    *Each 100 gram Pharmacy Bulk Package bag contains sterile ceftriaxone sodium equivalent to 100 grams of ceftriaxone SmartPak® system components are not made with natural rubber latex. Precautions As with other cephalosporins, reconstituted Ceftriaxone for Injection tends to darken depending on storage conditions within the stated recommendations. However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter. Storage Conditions Prior to reconstitution, store Ceftriaxone for Injection sterile powder at room temperature 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] and protected from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFTRIAXONE- CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION
SAMSON MEDICAL TECHNOLOGIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFTRIAXONE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEFTRIAXONE FOR
INJECTION.
CEFTRIAXONE FOR INJECTION, USP
CEFTRIAXONE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1984
PHARMACY BULK PACKAGE -
NOT FOR DIRECT INFUSION
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. (12.4)
INDICATIONS AND USAGE
Ceftriaxone for Injection, USP is a cephalosporin antibacterial
indicated for the treatment of the following
infections caused by susceptible isolates of the designated bacteria:
Lower Respiratory Tract Infections
(1.1); Skin and Skin Structure Infections (1.2); Complicated and
Uncomplicated Urinary Tract Infections
(1.3); Pelvic Inflammatory Disease (1.4); Bacterial Septicemia (1.5);
Bone and Joint infections (1.6); Intra-
abdominal Infections (1.7); Meningitis (1.8); and Surgical Prophylaxis
(1.9).
DOSAGE AND ADMINISTRATION
For intravenous use only over approximately 30 minutes. (2)
THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION.
CEFTRIAXONE FOR INJECTION USP, PHARMACY BULK PACKAGE BAG SMARTPAK
SHOULD BE USED ONLY
IN PATIENTS WHO REQUIRE A 1 GRAM DOSE AND NOT ANY FRACTION THEREOF.
CEFTRIAXONE FOR
INJECTION USP, PHARMACY BULK PACKAGE BAG SMARTPAK SHOULD NOT BE USED
IN PATIENTS WHO
REQUIRE LESS THAN THE 1 GRAM DOSE OF CEFTRIAXONE (2.1).
*
RECOMMENDED DOSING SCHEDULE FOR CEFTRIAXONE FOR INJECTION, USP
SITE AND TYPE OF
INFECTION
DOSE
FREQUENCY
TOTAL DAILY DOSE
Usual Adult Dose
1 to 2 grams
Once a day or in
equally divided doses
every 12 hours
Should not
exceed 4 grams
Surgical prophylaxis
1 gram I.V.
once
½ to 2 hours before
surgery
Meningitis
100 m