Cefoxitin

What is Cefoxitin?

• Cefoxitin (Mefoxin) is a semi-synthetic, broad-spectrum cephalosporin antibiotic for parenteral administration used to treat infections caused by bacteria including pneumonia and other lower respiratory tract infections; and urinary tract, abdominal, female reproductive organs, blood, bone, joint, and skin infections.
• It is also be used before and during surgery, in order to prevent the patient from getting an infection.
• It is derived from cephalosporin C, which is produced by Cephalosporium Acremonium.

Cefoxitin

Cefoxitin Structural Formula V1

What are the uses of this medicine?

Cefoxitin (Mefoxin) is indicated for the treatment of serious infections as fallows:

• Lower respiratory tract infections
• Urinary tract infections
• Intra-abdominal infections
• Gynecological infections
• Septicemia
• Bone and joint infections
• Skin and skin structure infections

Prevention:

• Cefoxitin for Injection, is used for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section.

How does this medicine work?

• Cefoxitin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.
• Cefoxitin has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

Cefoxitin has been shown to be active against most isolates of the following bacteria:

Gram-positive bacteria:

• Staphylococcus aureus (methicillin-susceptible isolates only)
• Staphylococcus epidermidis (methicillin-susceptible isolates only)
• Streptococcus agalactiae
• Streptococcus pneumoniae
• Streptococcus pyogenes

Gram-negative bacteria:

• Escherichia coli
• Haemophilus influenzae
• Klebsiella spp.
• Morganella morganii
• Neisseria gonorrhoeae
• Proteus mirabilis
• Proteus vulgaris
• Providencia spp.

Anaerobic bacteria:

• Clostridium spp.
• Peptococcus niger
• Peptostreptococcus spp.
• Bacteroides spp.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• amikacin, gentamicin, kanamycin, neomycin (Neo-Fradin), probenecid (Probalan), streptomycin, and tobramycin.

Is this medicine FDA approved?

• Cefoxitin is a second-generation cephamycin antibiotic developed by Merck & Co., Inc. from Cephamycin C in the year following its discovery, 1972.
• It was synthesized in order to create an antibiotic with a broader spectrum.
• It is often grouped with the second-generation cephalosporins.
• Cefoxitin requires a prescription and as of 2010 is sold under the brand name Mefoxin by Bioniche Pharma, LLC.

How should this medicine be used?

Recommended dosage: Adults:

• The usual adult dosage range is 1 gram to 2 grams every 6 to 8 hours.
• If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism.

• In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given.
• In patients undergoing hemodialysis, the loading dose of 1gram to 2 grams should be given after each hemodialysis.

Pediatric Patients:

• The recommended dosage in pediatric patients 3 months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses.
• The higher dosages should be used for more severe or serious infections.
• The total daily dosage should not exceed 12 grams.

Prophylactic use: Adults:

• 2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

Pediatric Patients (3 months and older):

• 30 to 40 mg/kg doses may be given at the times designated above.

Cesarean Section Patients:

• For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended.

Administration:

• Cefoxitin injection comes as a powder to be mixed with liquid to be injected intravenously.
• Cefoxitin injection is also available as a premixed product to be injected intravenously.
• It is usually given every six or eight hours.
• The length of your treatment depends on the type of infection you have and how your body responds to the medication.
• You may receive cefoxitin injection in a hospital or you may administer the medication at home.
• If you will be receiving cefoxitin injection at home, your healthcare provider will show you how to use the medication.
• You should begin to feel better during the first few days of treatment with cefoxitin injection.
• If your symptoms do not improve or get worse, call your doctor.
• Use cefoxitin injection until you finish the prescription, even if you feel better.
• If you stop using cefoxitin injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cefoxitin for Injection, USP contains approximately 53.8 mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity.

This medicine is available in fallowing brand namesː

• Mefoxin

What side effects can this medication cause?

The most common side effects of this medicine include: Local Reactions:

• Thrombophlebitis

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 reported.

Renal Function:

• Elevations in serum creatinine and/or blood urea nitrogen levels have been observed.

What special precautions should I follow?

• 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.
• If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Tell your doctor if you have or have ever had any kind of allergies, myasthenia gravis, gastrointestinal disease, especially colitis, or kidney disease.
• The total daily dose should be reduced when Cefoxitin for Injection is administered to patients with transient or persistent reduction of urinary output due to renal insufficiency.
• Antibiotics (including cephalosporins) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
• Prescribing Cefoxitin for Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Patients should be counseled that antibacterial drugs including Cefoxitin for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefoxitin for Injection or other antibacterial drugs in the future.
• Diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the treatment with antibiotics, patients can develop watery and bloody stools even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
• Cefoxitin is excreted in human milk in low concentrations. Caution should be exercised when Cefoxitin for Injection is administered to a nursing woman.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and efficacy in pediatric patients from birth to 3 months of age have not yet been established.
• In pediatric patients 3 months of age and older, higher doses of Cefoxitin for Injection have been associated with an increased incidence of eosinophilia and elevated SGOT.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• CEFOXITIN SODIUM

Inactive Ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured for:

• WG Critical Care, LLC
• Paramus, NJ
• Made in Italy

What should I know about storage and disposal of this medication?

• Cefoxitin for Injection, USP in the dry state should be stored between 2º to 25ºC (36º to 77ºF).
• Avoid exposure to temperatures above 50ºC.
• The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.

• Dailymed label info on Cefoxitin
• FDA Cefoxitin

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