Cefoxitin 100 g/1
cefoxitin · INJECTION, POWDER, FOR SOLUTION · SAMSON MEDICAL TECHNOLOGIES LLC
Cefoxitin is a injection, powder, for solution containing cefoxitin at 100 g/1, taken intravenous. Manufactured by SAMSON MEDICAL TECHNOLOGIES LLC.
Key Facts
- Brand Name
- Cefoxitin
- Generic Name
- cefoxitin
- NDC Code (Product)
66288-4100- Manufacturer
- SAMSON MEDICAL TECHNOLOGIES LLC
- Strength
- 100 g/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA200938
- Marketing Start
- 03/01/2016
Recall History
Sentara Infusion Services
Lack of sterility assurance
B. Braun Medical Inc
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Walgreens Infusion Services
Lack of sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Treatment: CEFOXITIN FOR INJECTION, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) 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 penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species. (2) Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri ). (3) Intra-abdominal infections , including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species. (4) Gynecological infections , including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli , Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides speci…
Dosage & Administration
DOSAGE AND ADMINISTRATION: Treatment: Adults: The usual adult dosage range is 1 gram to 2 grams every 6 to 8 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). If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism. CEFOXITIN FOR INJECTION may be used in patients with reduced renal function with the following dosage adjustments: In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide. When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function. Males: Weight (kg) x (140-age) 72 x serum creatinine (mg/100 mL) Females: 0.85 x above value In patients undergoing hemodialysis, the loading dose of 1 gram to 2 grams should be given after each…
Warnings
WARNINGS: BEFORE THERAPY WITH CEFOXITIN FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOXITIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFOXITIN FOR INJECTION OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES. Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including cefoxitin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be consi…
Contraindications
CONTRAINDICATIONS: CEFOXITIN FOR INJECTION is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.
Drug Interactions
Drug Interactions: Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Adverse Reactions
ADVERSE REACTIONS: CEFOXITIN FOR INJECTION is generally well tolerated. The most common adverse reactions have been local reactions following intravenous injection. Other adverse reactions have been encountered infrequently. Local Reactions: Thrombophlebitis has occurred with intravenous administration. Allergic Reactions: Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic reactions including anaphylaxis, interstitial nephritis and angioedema have been noted. Cardiovascular: Hypotension. Gastrointestinal: Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely. Neuromuscular: Possible exacerbation of myasthenia gravis. Blood: Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia, including hemolytic anemia, thrombocytopenia, and bone marrow depression. A positive direct Coombs test may develop in some individuals, especially those with azotemia. Liver Function: Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been rep…
Frequently Asked Questions
What is Cefoxitin used for?
Cefoxitin contains cefoxitin. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Cefoxitin a controlled substance?
Cefoxitin is not classified as a controlled substance by the DEA.
What is the generic name for Cefoxitin?
The generic name for Cefoxitin is cefoxitin. There are 2 other brand versions of cefoxitin.
What is the NDC code for Cefoxitin 100 g/1?
The NDC (National Drug Code) for Cefoxitin 100 g/1 is 66288-4100, listed by SAMSON MEDICAL TECHNOLOGIES LLC.