Cefoxitin and Dextrose 2 g/50mL
CEFOXITIN SODIUM · INJECTION, SOLUTION · B. Braun Medical Inc.
Cefoxitin and Dextrose is a injection, solution containing cefoxitin sodium at 2 g/50mL, taken intravenous. Manufactured by B. Braun Medical Inc..
Key Facts
- Brand Name
- Cefoxitin and Dextrose
- Generic Name
- CEFOXITIN SODIUM
- NDC Code (Product)
0264-3125- Manufacturer
- B. Braun Medical Inc.
- Strength
- 2 g/50mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA065214
- Marketing Start
- 03/10/2006
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cefoxitin 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 ( 1 ): Lower respiratory tract infections ( 1.1 ); Urinary tract infections ( 1.2 ); Intra-abdominal infections ( 1.3 ); Gynecological infections ( 1.4 ); Septicemia ( 1.5 ); Bone and joint infections ( 1.6 ); Skin and skin structure infections ( 1.7 ); Prophylaxis ( 1.8 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefoxitin for Injection and Dextrose Injection and other antibacterial drugs, Cefoxitin 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 ( 1.9 ). 1.1 Lower Respiratory Tract Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous use only. ( 2 ) Use this formulation of cefoxitin only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. ( 2.3 ) See full prescribing information for dose adjustment in patients with impaired renal function. ( 2.3 ) Recommended dosing schedule in patients with normal renal function. ( 2.1 ) 2.1 Dosage in Adults for Treatment The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines). Administer Cefoxitin for Injection and Dextrose Injection intravenously over approximately 30 minutes. If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism [see Indications and Usage (1.4) ] . Antibacterial therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, …
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to cefoxitin or other beta-lactam antibacterial drugs. ( 4.1 ) Hypersensitivity to corn products. ( 4.2 ) 4.1 Hypersensitivity to Cefoxitin or other Beta-lactam Antibacterial Drugs Cefoxitin for Injection and Dextrose Injection is contraindicated in patients who have shown hypersensitivity to cefoxitin or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). 4.2 Hypersensitivity to Corn Products Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Drug Interactions
7 DRUG INTERACTIONS Aminoglycosides: Increased potential of nephrotoxicity. ( 7.1 ) 7.1 Aminoglycosides Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibacterials.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of labeling: • Hypersensitivity Reactions to Cefoxitin or other Beta-lactam Antibacterial Drugs [see Warnings and Precautions (5.1)] • Use in Patients with Renal Impairment [see Dosage and Administration (2.3) , Use in Specific Populations (8.6)] • Clostridium difficile -associated Diarrhea [see Warnings and Precautions (5.2)] • Risk of Development of Drug-resistant Bacteria [see Warnings and Precautions (5.3)] • Drug/Laboratory Test Interactions [see Warnings and Precautions (5.4)] • Patients with a History of Gastrointestinal Disease [see Warnings and Precautions (5.5) ] • Patients with Overt or Known Subclinical Diabetes Mellitus or Carbohydrate Intolerance [see Warnings and Precautions (5.6) ] The most common adverse reactions have been local reactions following intravenous injection. Local Reactions Thrombophlebitis has occurred with intravenous administration. Skin and Subcutaneous Tissue Disorders Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic react…
Frequently Asked Questions
What is Cefoxitin and Dextrose used for?
Cefoxitin and Dextrose contains CEFOXITIN SODIUM. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Cefoxitin and Dextrose a controlled substance?
Cefoxitin and Dextrose is not classified as a controlled substance by the DEA.
What is the generic name for Cefoxitin and Dextrose?
The generic name for Cefoxitin and Dextrose is CEFOXITIN SODIUM. There are 2 other brand versions of CEFOXITIN SODIUM.
What is the NDC code for Cefoxitin and Dextrose 2 g/50mL?
The NDC (National Drug Code) for Cefoxitin and Dextrose 2 g/50mL is 0264-3125, listed by B. Braun Medical Inc..