CEFTRIAXONE AND DEXTROSE- ceftriaxone injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

B. Braun Medical Inc.

INN (International Name):

CEFTRIAXONE SODIUM

Composition:

CEFTRIAXONE 1 g in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ceftriaxone for Injection and Dextrose 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 epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii 1, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis 1 or Peptostreptococcus species. Complicated and uncomplicated urinary tract infections caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae . Pelvic inflammatory disease caused by Neisseria gono

Product summary:

Ceftriaxone for Injection and Dextrose Injection in the DUPLEX® Container is a flexible dual chamber container supplied in two concentrations. After reconstitution, the concentrations are equivalent to 1 g and 2 g ceftriaxone. The diluent chamber contains approximately 50 mL of Dextrose Injection. Dextrose Injection has been adjusted to 3.74% and 2.22% for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic. Ceftriaxone for Injection and Dextrose Injection is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 single-dose units per case. Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Do not freeze. Precautions As with other cephalosporins, reconstituted Ceftriaxone for Injection and Dextrose 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. Do not use in series connection. Do not introduce additives into the DUPLEX® container.

Authorization status:

New Drug Application

Summary of Product characteristics

CEFTRIAXONE AND DEXTROSE- CEFTRIAXONE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFTRIAXONE FOR
INJECTION AND DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
CEFTRIAXONE FOR INJECTION AND DEXTROSE INJECTION.
CEFTRIAXONE FOR INJECTION AND DEXTROSE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2005
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ceftriaxone for
Injection and Dextrose Injection and other antibacterial drugs,
Ceftriaxone for Injection and Dextrose
Injection should be used only to treat or prevent infections that are
proven or strongly suspected to be
caused by bacteria. (1)
RECENT MAJOR CHANGES
Warnings and Precautions, Neurological Adverse Reactions (5.3) 1/2022
INDICATIONS AND USAGE
Ceftriaxone for Injection and Dextrose Injection 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).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ceftriaxone for
Injection and Dextrose Injection and other antibacterial drugs,
Ceftriaxone for Injection and Dextrose
Injection should be used only to treat or prevent infections that are
proven or strongly suspected to be
caused by bacteria. (1.10)
DOSAGE AND ADMINISTRATION
For intravenous use only over approximately 30 minutes. (2)
Use this formulation of ceftriaxone only in patients who require the
entire 1 or 2 gram dose and not any
fraction thereof. (2.1)
*
RECOMMENDED DOSING SCHEDULE FOR CEFTRIAXONE FOR INJECTION AND DEXTROS