FDA

Cefoxitin and Dextrose in Duplex Container

Approved 10 Mar 2006InjectionInjectable

The FDA lists this product in 2 strengths and forms.

Indications

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 ).

1.1Lower 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 penicillinase-producing strains), Escherichia coli , Klebsiella species, Haemophilus influenzae , and Bacteroides species.

1.2Urinary Tract Infections Cefoxitin for Injection and Dextrose

Injection is indicated for the treatment of urinary tract infections caused by Escherichia coli , Klebsiella species, Proteus mirabilis , Morganella morganii , Proteus vulgaris and Providencia species (including P. rettgeri ).

1.3Intra-abdominal Infections Cefoxitin for Injection and Dextrose

Injection is indicated for the treatment of intra-abdominal infections , including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species.

1.4

Indications

1.1Lower Respiratory Tract Infections Cefoxitin for Injection and Dextrose

1.2Urinary Tract Infections Cefoxitin for Injection and Dextrose

1.3Intra-abdominal Infections Cefoxitin for Injection and Dextrose

1.4

Warnings and precautions

Hypersensitivity reactions including anaphylaxis and serious skin reactions. If an allergic reaction occurs, discontinue the drug. ( 5.1 ) Use in patients with renal impairment: Dosage adjustment required for patients with impaired renal function. ( 2.3 ) Clostridium difficile -associated diarrhea: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. ( 5.2 )

5.1Hypersensitivity Reactions to Cefoxitin

or other Beta-lactam Antibacterial Drugs Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis) have been reported in patients on β-lactam antibacterials, including cefoxitin [see Adverse Reactions (6.1) ] . These reactions are more likely to occur in individuals with a history of β-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.

Cefoxitin for Injection and Dextrose Injection is contraindicated in patients with a known hypersensitivity to Cefoxitin for Injection and Dextrose Injection or other β-lactam antibacterial drugs [see Contraindications (4) ] . Before initiating therapy with Cefoxitin for Injection and Dextrose Injection, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue Cefoxitin for Injection and Dextrose Injection and institute appropriate therapy.

5.2 Clostridium difficile -associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefoxitin for Injection and Dextrose Injection, 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.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.3 Risk of Development of Drug-resistant Bacteria Prescribing Cefoxitin for Injection and Dextrose 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. Prolonged use of Cefoxitin for Injection and Dextrose Injection may result in overgrowth of non-susceptible microorganisms.

Repeated evaluation of the patient's condition is essential. Should superinfection occur during therapy, appropriate measures should be taken.

5.4 Drug/Laboratory Test Interactions As with cephalothin, high concentrations of cefoxitin (>100 mcg/mL) may interfere with measurement of serum and urine creatinine levels by Jaffé reaction, and produce false increases of modest degree in the levels of creatinine reported. Serum samples from patients treated with cefoxitin should not be analyzed for creatinine if withdrawn within 2 hours of drug administration. High concentrations of cefoxitin in the urine may interfere with measurement of urinary 17-hydroxy-corticosteroids by the Porter-Silber reaction, and produce false increases of modest degree in the levels reported.

A false-positive reaction for glucose in the urine may occur. This has been observed with CLINITEST® reagent tablets.

5.5Patients with a History of Gastrointestinal Disease Cefoxitin for Injection and Dextrose

Injection is not recommended in individuals with a history of gastrointestinal disease, particularly colitis.

5.6 Patients with Overt or Known Subclinical Diabetes Mellitus or Carbohydrate Intolerance As with other dextrose-containing solutions, Cefoxitin for Injection and Dextrose Injection should be monitored if Cefoxitin for Injection and Dextrose Injection is prescribed in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Available data from published prospective cohort studies, case series, and case reports over several decades with cephalosporin use, including cefoxitin, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and mice administered parenteral doses of cefoxitin at approximately 1 to 7.5 times the maximum recommended human dose (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Cefoxitin is found in umbilical cord blood and amniotic fluid after maternal administration.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections and bloodstream infections. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with cephalosporin use, including cefoxitin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Reproduction studies performed in pregnant 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.

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.

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 reactions including anaphylaxis, interstitial nephritis and angioedema have been noted. Cardiovascular Disorders Hypotension. Gastrointestinal Disorders Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment. Nausea and vomiting have been reported. Nervous System Disorders Possible exacerbation of myasthenia gravis. Blood and Lymphatic System Disorders 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. Hepatobiliary Disorders Reversible elevation in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported. Renal and Urinary Disorders Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. Acute renal failure has been reported. Most common adverse reactions: Local reactions. ( 6 ) 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.

6.1Cephalosporin-class Adverse Reactions

In addition to the adverse reactions listed above which have been observed in patients treated with cefoxitin, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibacterials: pruritus, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, vomiting, abdominal pain, colitis, superinfection, vaginitis including vaginal candidiasis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, elevated bilirubin, pancytopenia, and neutropenia.

Several cephalosporins, including Cefoxitin for Injection and Dextrose Injection, have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced [ see Dosage and Administration (2.3) and Overdosage (10 ) ] . If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Cefoxitin and Dextrose in Duplex Container

Indications

1.1Lower Respiratory Tract Infections Cefoxitin for Injection and Dextrose

1.2Urinary Tract Infections Cefoxitin for Injection and Dextrose

1.3Intra-abdominal Infections Cefoxitin for Injection and Dextrose

1.4

Two medicines in one question?

Cefoxitin and Dextrose in Duplex Container

Indications

1.1Lower Respiratory Tract Infections Cefoxitin for Injection and Dextrose

1.2Urinary Tract Infections Cefoxitin for Injection and Dextrose

1.3Intra-abdominal Infections Cefoxitin for Injection and Dextrose

1.4

Two medicines in one question?

1.5Septicemia Cefoxitin for Injection and Dextrose

1.6Bone and Joint Infections Cefoxitin for Injection and Dextrose

1.7Skin and Skin Structure Infections Cefoxitin for Injection and Dextrose

1.8Prophylaxis Cefoxitin for Injection and Dextrose

1.9Usage

Contraindications

4.1Hypersensitivity to Cefoxitin

4.2Hypersensitivity to Corn Products

Warnings and precautions

5.1Hypersensitivity Reactions to Cefoxitin

5.5Patients with a History of Gastrointestinal Disease Cefoxitin for Injection and Dextrose

Interactions

7.1Aminoglycosides

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Cephalosporin-class Adverse Reactions

Composition

Strengths and forms

Official product information

At a glance