pharmacopeia
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/api/v1/drug/cefoxitin

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Enzyme Inhibitors.

Enzyme

Indications

Sourced from openFDA
  • 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.ICD-10: J18.9

Contraindications

Sourced from openFDA
  • CEFOXITIN FOR INJECTION is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.contraindicated

Dosage & administration

Sourced from openFDA

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 hemodialysis, and the maintenance dose should be given as indicated in Table 2. Antibiotic 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, surgical drainage should be carried out where indicated.

Warnings & precautions

Sourced from openFDA

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 considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Adverse reactions

Sourced from openFDA

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 reported. Renal Function: Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. As with the cephalosporins, acute renal failure has been reported rarely. The role of CEFOXITIN FOR INJECTION in changes in renal function tests is difficult to assess, since factors predisposing to prerenal azotemia or to impaired renal function usually have been present.

Use in specific populations

Sourced from openFDA

Pregnancy: Reproduction studies performed in rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects, although a slight decrease in fetal weight was observed. 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. In the rabbit, cefoxitin was associated with a high incidence of abortion and maternal death. This was not considered to be a teratogenic effect but an expected consequence of the rabbit's unusual sensitivity to antibiotic-induced changes in the population of the microflora of the intestine.

Overdosage

Sourced from openFDA

The acute intravenous LD 50 in the adult female mouse and rabbit was about 8 g/kg and greater than 1 g/kg, respectively. The acute intraperitoneal LD 50 in the adult rat was greater than 10 g/kg.

Approval history

Sourced from openFDA
  • Mar 10, 2006NDANDA065214B Braun
  • Jun 12, 2009ANDAANDA065414Acs Dobfar
  • Feb 26, 2010ANDAANDA065239Hikma Farmaceutica
  • Mar 12, 2010ANDAANDA065238Hikma Farmaceutica
  • May 19, 2010ANDAANDA065415Acs Dobfar
  • Nov 16, 2015ANDAANDA200938Samson Medcl

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,361 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use916.7%
  2. 2Drug Resistance896.5%
  3. 3Nausea805.9%
  4. 4Drug Reaction With Eosinophilia And Systemic Symptoms785.7%
  5. 5Rash745.4%
  6. 6Drug Ineffective634.6%
  7. 7Product Use In Unapproved Indication624.6%
  8. 8Thrombocytopenia624.6%
  9. 9Condition Aggravated564.1%
  10. 10Dyspnoea513.7%
  11. 11Pyrexia503.7%
  12. 12Diarrhoea493.6%
  13. 13Hypotension443.2%
  14. 14Acute Kidney Injury433.2%
  15. 15Vomiting423.1%

Literature

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Recent PubMed references pinned to Cefoxitin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 42 ClinicalTrials.gov registrations naming Cefoxitin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cefoxitin work?
Mechanism-of-action class: Enzyme Inhibitors.
What is Cefoxitin used for?
According to FDA labeling, Cefoxitin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cefoxitin?
Cefoxitin is classified as Second-generation cephalosporins, Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.
What are the contraindications for Cefoxitin?
Cefoxitin labeling lists contraindications including: CEFOXITIN FOR INJECTION is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.. Always consult the full prescribing information and a clinician.
Note. Data for cefoxitin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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