CEFTRIAXONE AND DEXTROSE 2 g/50mL

CEFTRIAXONE · INJECTION, SOLUTION · B. Braun Medical Inc.

No Recall History

Plain English

CEFTRIAXONE AND DEXTROSE is a injection, solution containing ceftriaxone at 2 g/50mL, taken intravenous. Manufactured by B. Braun Medical Inc..

Key Facts

Brand Name: CEFTRIAXONE AND DEXTROSE
Generic Name: CEFTRIAXONE
NDC Code (Product): 0264-3155
Manufacturer: B. Braun Medical Inc.
Strength: 2 g/50mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA050796
Marketing Start: 04/20/2005

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Ceftriaxone for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible bacteria. 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 ) 1.1 Lower Respiratory Tract Infections Lower respiratory tract infections caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influ…

Dosage & Administration

2 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 Dextrose Injection Site and Type of Infection Dose Frequency Total Daily Dose Usual Adult Dose 1 g to 2 g once a day or in equally divided doses every 12 hours should not exceed 4 g Patients with hepatic impairment and significant renal impairment should not receive more than 2 grams per day of ceftriaxone. Surgical Prophylaxis 1 gram IV once 1/2 to 2 hours before surgery Meningitis 100 mg/kg once a day or in equally divided doses every 12 hours should not exceed 4 g Skin and Skin Structure Infections 50 mg/kg to 75 mg/kg once a day or in equally divided doses every 12 hours should not exceed 2 g Serious Infections other than Meningitis 50 mg/kg to 75 mg/kg every 12 hours should not exceed 2 g 2.1 Adult Population Ceftriaxone for Injection and Dextrose Injection in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. The recommended a…

Contraindications

4 CONTRAINDICATIONS Anaphylaxis to ceftriaxone or other cephalosporin class antibacterials, penicillins, or other beta-lactam antibacterials ( 4.1 ) 4.1 Anaphylaxis to Ceftriaxone or the Cephalosporin Class of Antibacterials, Penicillins, or Other Beta-lactam Antibacterials Ceftriaxone for Injection and Dextrose Injection is contraindicated in patients who have a history of anaphylaxis to ceftriaxone or the cephalosporin class of antibacterials, penicillins, or other beta-lactam antibacterials [see Warnings and Precautions (5.1) ].

Drug Interactions

7 DRUG INTERACTIONS Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible. ( 7.1 ) Calcium-containing products: precipitation can occur. ( 7.2 ) 7.1 Vancomycin, Amsacrine, Aminoglycosides, and Fluconazole Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures [see Dosage and Administration (2.3) ]. 7.2 Calcium-containing Products Precipitation of ceftriaxone-calcium can occur when Ceftriaxone for Injection and Dextrose Injection is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone for Injection and Dextrose Injection must not be administered simultaneously with calcium-containing IV solutions. Ceftriaxone for Injection and Dextrose Injection and calcium-containing solutions may be administered sequentially. [see Warnings and Precautions (5.2) ]

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions to ceftriaxone are described below and elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1) ] Ceftriaxone-calcium precipitates [see Warnings and Precautions (5.2) and Drug Interactions (7.2) ] Neurological Adverse Reactions [see Warnings and Precautions (5.3) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.4) ] Hemolytic anemia [see Warnings and Precautions (5.5) ] The most common adverse reactions occurring in greater than 2% of patients receiving ceftriaxone include diarrhea, eosinophilia, thrombocytosis, leukopenia, and elevations of SGOT and SGPT. To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following reactions occurred in less than or equal to 6% of the patients: Lo…

Frequently Asked Questions

What is CEFTRIAXONE AND DEXTROSE used for?

CEFTRIAXONE AND DEXTROSE contains CEFTRIAXONE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is CEFTRIAXONE AND DEXTROSE a controlled substance?

CEFTRIAXONE AND DEXTROSE is not classified as a controlled substance by the DEA.

What is the generic name for CEFTRIAXONE AND DEXTROSE?

The generic name for CEFTRIAXONE AND DEXTROSE is CEFTRIAXONE. There are 11 other brand versions of CEFTRIAXONE.

What is the NDC code for CEFTRIAXONE AND DEXTROSE 2 g/50mL?

The NDC (National Drug Code) for CEFTRIAXONE AND DEXTROSE 2 g/50mL is 0264-3155, listed by B. Braun Medical Inc..

Product NDC

0264-3155

Package NDC

0264-3155-11

Other Ceftriaxone Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)