Cefotaxime

Dosage Forms & Strengths

injectable solution

• 20mg/mL
• 40mg/mL

powder for injection

• 500mg
• 1g
• 2g
• 10g

Gonococcal Urethritis/Cervicitis

0.5 g IM once

Gonorrhea, Rectal

Men: 1 g IM once

Women: 0.5 g IM once

Infections Caused by Susceptible Organisms

Uncomplicated: 1 g IV or IM q12hr

Moderate to severe: 1-2 g IV or IM q8hr

More serious (bloodstream infection [septicemia]): 2 g IV q6-8hr

Life-threatening: 2 g IV q4hr; not to exceed 12 g/day

Preparation for Surgery

Prophylaxis of surgical infection

1 g IM/IV once 30-90 minutes before start of procedure

Dosing Considerations

Susceptible organisms

• Bacteroides spp, Citrobacter spp, Clostridium spp, Enterobacter spp, Escherichia coli, Haemophilus influenzae, Klebsiella spp, Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Peptococcus spp, Peptostreptococcus spp, Proteus mirabilis, Providencia rettgeri, Pseudomonas spp, Serratia spp, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes

Dosage Forms & Strengths

injectable solution

• 20mg/mL
• 40mg/mL

powder for injection

• 500mg
• 1g
• 2g
• 10g

Infections Caused by Susceptible Organisms

<12 years or <50 kg: 50-200 mg/kg/day IV/IM divided q6-8hr 

>12 years or >50 kg: 1-2 g IV/IM q8hr

Epiglottitis

<12 years or <50 kg: 150-200 mg/kg/day IV/IM divided q6hr plus clindamycin for 7-10 days 

>12 years or >50 kg: 1-2 g IV/IM q8hr

Meningitis

<12 years or <50 kg: 200 mg/kg/day IV/IM divided q6hr 

>12 years or >50 kg: 2 g IV q4-6hr in combination with other antimicrobial therapy as necessary

Pneumonia

<12 years or <50 kg: 200 mg/kg/day IV divided q8hr 

>12 years or >50 kg: 1-2 g IV/IM q8hr

Sepsis

<12 years or <50 kg: 150 mg/kg/day IV divided q8hr 

>12 years or >50 kg: 2 g IV q6-8hr

Typhoid Fever

<12 years or <50 kg: 150-200 mg/kg/day IV/IM divided q6-8hr; not to exceed 12 g/day 

Fluoroquinolone resistant: 80 mg/kg/day IV/IM divided q6-8hr; not to exceed 12 g/day

>12 years or >50 kg: 1-2 g IV/IM q4-8hr

Dosing Considerations

Usual dosage range in children

• 0-1 week: 50 mg/kg IV q12hr
• 1-4 weeks: 50 mg/kg IV q8hr
• 1 month-12 years: 50-180 mg/kg/day IV divided q4-6hr
• >12 years: 1-2 g IV/IM q4-8hr

Sterile CLAFORAN (cefotaxime sodium) is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). CLAFORAN contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of CLAFORAN range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4.

CLAFORAN is supplied as a dry powder in conventional and ADD-Vantage® System compatible vials, infusion bottles, pharmacy bulk package bottles, and as a frozen, premixed, iso-osmotic injection in a buffered diluent solution in plastic containers. CLAFORAN, equivalent to 1 gram and 2 grams cefotaxime, is supplied as frozen, premixed, iso-osmotic injections in plastic containers. Solutions range from very pale yellow to light amber. Dextrose Hydrous, USP has been added to adjust osmolality (approximately 1.7 g and 700 mg to the 1 g and 2 g cefotaxime dosages, respectively). The injections are buffered with sodium citrate hydrous, USP. The pH is adjusted with hydrochloric acid and may be adjusted with sodium hydroxide.

The plastic container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

Sterile CLAFORAN is a dry off-white to pale yellow crystalline powder supplied in vials and bottles containing cefotaxime sodium as follows:

500 mg cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0017-10).

1 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0018-10), packages of 25 (NDC 0039-0018-25), packages of 50 (NDC 0039-0018-50); infusion bottles in packages of 10 (NDC 0039-0018-11).

2 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0019-10), packages of 25 (NDC 0039-0019-25), packages of 50 (NDC 0039-0019-50); infusion bottles in packages of 10 (NDC 0039-0019-11).

1 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 00390023-25) and 50 (NDC 0039-0023-50).

2 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 00390024-25) and 50 (NDC 0039-0024-50).

ADD-Vantage System diluents (5% Dextrose or 0.9% Sodium Chloride) are available from Abbott Laboratories.

Also available:

Pharmacy Bulk Package:

10g cefotaxime (free acid equivalent) in bottles (NDC 0039-0020-01)

NOTE: CLAFORAN in the dry state should be stored below 30°C. The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light.

Premixed CLAFORAN Injection is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in 50 mL single dose Galaxy containers (PL 2040 plastic) as follows:

1 g cefotaxime (free acid equivalent) in packages of 12 (NDC 0039-0037-05) 2G3518.

2 g cefotaxime (free acid equivalent) in packages of 12 (NDC 0039-0038-05) 2G3519.

NOTE: Store Premixed CLAFORAN Injection at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF CLAFORAN (cefotaxime injection) IN GALAXY CONTAINERS (PL 2040 PLASTIC)].

CLAFORAN Injection supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in Galaxy containers (PL 2040 plastic) is manufactured for sanofi-aventis U.S. LLC by Baxter Healthcare Corporation.

Revised February 2014. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807, Claforan Injection in Galaxy Containers: Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807

Common side effects of cefotaxime include:

• irritation at the site of injection
• diarrhea
• rash
• itching
• diarrhea
• nausea
• vomiting
• fever

This is not a complete list of cefotaxime side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cefotaxime. See the “Drug Precautions” section.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take cefotaxime exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

If you miss a dose, be sure to make a follow up appointment.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

If you are receiving this medication at a clinic, call your doctor if you miss an appointment for your injection.

Clinical Trials Experience

CLAFORAN is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.

The most frequent adverse reactions (greater than 1%) are:

Local (4.3%) -Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.

Hypersensitivity (2.4%) -Rash, pruritus, fever, eosinophilia.

Gastrointestinal (1.4%) -Colitis, diarrhea, nausea, and vomiting.

Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.

Nausea and vomiting have been reported rarely.

Less frequent adverse reactions (less than 1%) are:

Hematologic System -Neutropenia, transient leukopenia, have been reported. Some individuals have developed positive direct Coombs Tests during treatment with CLAFORAN and other cephalosporin antibiotics.

Genitourinary System -Moniliasis, vaginitis.

Central Nervous System -Headache.

Liver -Transient elevations in AST, ALT, serum LDH, and serum alkaline phosphatase levels have been reported.

Kidney -As with some other cephalosporins, transient elevations of BUN have been occasionally observed with CLAFORAN.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of CLAFORAN. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular System -Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.

Central Nervous System -Administration of high doses of beta-lactam antibiotics, including cefotaxime, particularly in patients with renal insufficiency may result in encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions).

Cutaneous -As with other cephalosporins, isolated cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have been reported.

Hematologic System -Hemolytic anemia, agranulocytosis, thrombocytopenia.

Hypersensitivity -Anaphylaxis (e.g., angioedema, bronchospasm, malaise possibly culminating in shock), urticaria.

Kidney -Interstitial nephritis, transient elevations of creatinine.

Liver -Hepatitis, jaundice, cholestasis, elevations of gamma GT and bilirubin.

In addition to the adverse reactions listed above which have been observed in patients treated with cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. See DOSAGE AND ADMINISTRATION and OVERDOSAGE. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Read the entire FDA prescribing information for Claforan (Cefotaxime)

Sterile Cefotaxime sodium is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for Injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of Cefotaxime activity. Solutions of Cefotaxime for injection range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 4.5 to 6.5. The molecular formula is C16H16N5NaO7S2 and molecular weight is 477.45. The CAS Registry Number is 64485-93-4.

Cefotaxime for Injection, USP is supplied as a sterile dry powder in 1 gram and 2 gram ADD-VantageTM vials. Each vial contains Cefotaxime sodium equivalent to 1 gram or 2 gram of Cefotaxime. The 1 gram and 2 gram Add-Vantage vials are to be administered through intravenous route only.

General

Prescribing Cefotaxime 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.

Cefotaxime for Injection should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime for injection is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism.

Although there is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime sodium in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of Cefotaxime sodium be halved in patients with estimated creatinine clearances of less than 20 mL/min/1.73 m2.

When only serum creatinine is available, the following formula5 (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.

Weight (kg) x (140 - age)
     Males:        72 x serum creatinine
     Females:     0.85 × above value

As with other antibiotics, prolonged use of Cefotaxime for injection may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Leukopenia, neutropenia, granulocytopenia and, more rarely, bone marrow failure, pancytopenia, or agranulocytosis may develop during treatment with Cefotaxime for injection. For courses of treatment lasting longer than 10 days, blood counts should therefore be monitored and treatment discontinuation should be considered in case of abnormal results.

Cefotaxime for Injection, like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of Cefotaxime responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of Cefotaxime may result in tissue damage and require surgical treatment. To minimize the potential for tissue inflammation, infusion sites should be monitored regularly and changed when appropriate.

Information for patients

Patients should be counseled that antibacterial drugs including Cefotaxime for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefotaxime for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. 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 Cefotaxime 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 treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) 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.

Drug Interactions

As with other cephalosporins, Cefotaxime may potentiate the nephrotoxic effects of nephrotoxic drugs such as aminoglycosides, NSAIDs and furosemide.

Probenecid interferes with the renal tubular transfer of Cefotaxime, decreasing the total clearance of Cefotaxime by approximately 50% and increasing the plasma concentrations of Cefotaxime.

Administration of Cefotaxime in excess of 6 grams/day should be avoided in patients receiving probenecid (see CLINICAL PHARMACOLOGY, Drug Interactions).

Drug/Laboratory Test Interactions

Cephalosporins, including Cefotaxime sodium, are known to occasionally induce a positive direct Coombs’ test.

A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict’s or Fehling’s solution or with CLINITEST tablets), but not with enzyme-based tests for glycosuria (e.g., CLINISTIX or TesTape). There are no reports in published literature that link elevations of plasma glucose levels to the use of Cefotaxime.

Carcinogenesis, Mutagenesis

Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefotaxime for injection was not mutagenic in the mouse micronucleus test or in the Ames test. Cefotaxime for injection did not impair fertility to rats when administered subcutaneously at doses up to 250 mg/kg/day (0.2 times the maximum recommended human dose based on mg/m2) or in mice when administered intravenously at doses up to 2000 mg/kg/day (0.7 times the recommended human dose based on mg/m2).

Pregnancy: Teratogenic Effects: Pregnancy Category B: 

Reproduction studies have been performed in pregnant mice given Cefotaxime for injection intravenously at doses up to 1200 mg/kg/day (0.4 times the recommended human dose based on mg/m2) or in pregnant rats when administered intravenously at doses up to 1200 mg/kg/day (0.8 times the recommended human dose based on mg/m2). No evidence of embryotoxicity or teratogenicity was seen in these studies. Although Cefotaxime has been reported to cross the placental barrier and appear in cord blood, the effect on the human fetus is not known. There are no well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects

Use of the drug in women of child-bearing potential requires that the anticipated benefit be weighed against the possible risks.

In perinatal and postnatal studies with rats, the pups in the group given 1200 mg/kg/day of Cefotaxime for injection were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of nursing.

Nursing Mothers

Cefotaxime is excreted in human milk in low concentrations. Caution should be exercised when Cefotaxime for injection is administered to a nursing woman.

Pediatric Use

See PRECAUTIONS above regarding perivascular extravasation.

Geriatric Use

Of the 1409 subjects in clinical studies of Cefotaxime, 632 (45%) were 65 and over, while 258 (18%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, General).

Clinical Trials Experience

Cefotaxime for injection is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.

The most frequent adverse reactions (greater than 1%) are:

Local (4.3%) - Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.

Hypersensitivity (2.4%) - Rash, pruritus, fever, eosinophilia.

Gastrointestinal (1.4%) - Colitis, diarrhea, nausea, and vomiting.

Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.

Nausea and vomiting have been reported rarely.

Less frequent adverse reactions (less than 1%) are:

Hematologic System - Neutropenia, transient leukopenia, have been reported. Some individuals have developed positive direct Coombs Tests during treatment with Cefotaxime for injection and other cephalosporin antibiotics.

Genitourinary System - Moniliasis, vaginitis.

Central Nervous System - Headache.

Liver - Transient elevations in AST, ALT, serum LDH, and serum alkaline phosphatase levels have been reported.

Kidney - As with some other cephalosporins, transient elevations of BUN have been occasionally observed with Cefotaxime for injection.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of Cefotaxime for injection. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular System - Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.

Central Nervous System - Administration of high doses of beta-lactam antibiotics, including Cefotaxime, particularly in patients with renal insufficiency may result in encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions). Dizziness has also been reported.

Cutaneous - As with other cephalosporins, isolated cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have been reported. Acute generalized exanthematous pustulosis (AGEP) has also been reported.

General disorders and administration site conditions - Inflammatory reactions at the injection site, including phlebitis/thrombophlebitis.

Hematologic System - Hemolytic anemia, agranulocytosis, thrombocytopenia, pancytopenia, bone marrow failure.

Hypersensitivity - Anaphylaxis (e.g., angioedema, bronchospasm, malaise possibly culminating in shock), urticaria.

Kidney - Interstitial nephritis, transient elevations of creatinine, acute renal failure.

Liver - Hepatitis, jaundice, cholestasis, elevations of gamma GT and bilirubin.

Cephalosporin Class Labeling

In addition to the adverse reactions listed above which have been observed in patients treated with Cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. See DOSAGE AND ADMINISTRATION and OVERDOSAGE. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

• Claforan in D5W [DSC]
• Claforan [DSC]

• Antibiotic, Cephalosporin (Third Generation)

Acute bacterial rhinosinusitis

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults, cefotaxime (among other cephalosporins) is effective and recommended (in combination with clindamycin) for the treatment of ABRS.

Bacterial enteric infections in HIV-infected patients (empiric treatment) (adolescents and adults)

Based on the US Department of Health and Human Services (HHS) Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, cefotaxime is a recommended agent for empiric treatment of bacterial enteric infection in adolescent and adult HIV-infected patients with advanced HIV (CD4 count <200 cells/mm3 or concomitant AIDS-defining illness) and severe diarrhea (≥6 stools/day or bloody stool) and/or fever or chills.

Bite wounds (animal)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), cefotaxime, in combination with clindamycin or metronidazole for anaerobic coverage, is an effective and recommended alternative for treatment of bite wounds.

Community-acquired pneumonia (children)

Following clinical guideline recommendations on the management of CAP reduces the incidence of morbidity and mortality related to pneumonia. Cefotaxime is a preferred parenteral option for empirical treatment of suspected bacterial CAP in children not fully immunized in areas where local penicillin resistance in pneumococcal strains is high, and for pathogen-directed therapy aimed at beta-lactamase-producing H. influenzae in children older than 3 months of age.

Disseminated gonococcal infection (DGI) (infants)

Based on Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, cefotaxime is an effective and recommended treatment of disseminated gonococcal infection in infants.

Gonococcal scalp abscesses (infants)

Based on Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, cefotaxime is an effective and recommended treatment of gonococcal scalp abscesses infants.

Gonococcal, disseminated infection (arthritis and arthritis-dermatitis syndrome)

Based on Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, cefotaxime plus azithromycin is considered an alternative regimen for the treatment of arthritis and arthritis-dermatitis syndrome associated with disseminated gonococcal infection. Ceftriaxone plus azithromycin is the preferred regimen. Cefotaxime should not be used for the treatment of gonococcal meningitis and endocarditis due to disseminated gonococcal infection.

Lyme neuroborreliosis

Parenteral regimens for Lyme disease of the nervous system have a greater potential for morbidity. For severe neurologic disease, class 1 and 2 studies suggested that parenteral treatment (ie, cefotaxime, ceftriaxone, penicillin) was probably safe and effective, but class 2 and 3 studies also indicated that oral therapy (and doxycycline specifically) was comparably safe and effective for patients without parenchymal involvement.[AAN [Halperin 2007]]

Skin and soft tissue necrotizing infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), cefotaxime, in combination with metronidazole or clindamycin, is an effective and recommended alternative for empiric treatment of mixed (polymicrobial) necrotizing infections of the skin, fascia, and muscle; in combination with doxycycline, cefotaxime is effective and recommended for treatment of necrotizing infections of the skin, fascia, and muscle due to Vibrio vulnificus.

Some products may contain sodium.

Concerns related to adverse effects:

• Arrhythmia: A potentially life-threatening arrhythmia has been reported in patients who received a rapid (<1 minute) bolus injection via central venous catheter.

• Granulocytopenia: Granulocytopenia and more rarely agranulocytosis may develop during prolonged treatment (>10 days).

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

• Tissue inflammation: Minimize tissue inflammation by changing infusion sites when needed.

Disease-related concerns:

• Colitis: Use with caution in patients with a history of colitis.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be required.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Adverse events have not been observed in animal reproduction studies. Cefotaxime crosses the human placenta and can be found in fetal tissue. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins. During pregnancy, peak cefotaxime serum concentrations are decreased and the serum half-life is shorter. Cefotaxime is approved for use in women undergoing cesarean section (consult current guidelines for appropriate use).

Urethritis/cervicitis: 0.5 g IM once

Rectal gonorrhea:
-Females: 0.5 g IM once
-Males: 1 g IM once

Use: Treatment of uncomplicated cervical/urethral and rectal gonorrhea caused by Neisseria gonorrhoeae, including penicillinase producing strains

US Centers for Disease Control and Prevention (CDC) Recommendations:
Urogenital and anorectal infections: 500 mg IM once

Use: Alternative treatment of uncomplicated gonococcal infections of the cervix, urethra, and rectum

ASHP, IDSA, SIS, and SHEA Recommendations:
Pediatric patients: 50 mg/kg IV once PLUS ampicillin
-Maximum dose: 1 g/dose

Comment: The recommended redosing interval is 3 hours.

Use: Surgical antimicrobial prophylaxis in patients undergoing liver transplantation

IDSA Recommendations:
Children: 100 to 200 mg/kg IV per day, given in divided doses every 6 hours

Use: Treatment of severe acute bacterial rhinosinusitis requiring hospitalization

Peak concentrations of 0.25 to 0.52 mcg/mL were measured 2 to 3 hours after IV administration.

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant. Excreted into human milk: Yes Comment: Maternal doses of cephalosporins have resulted in reports of neonatal diarrhea and thrush.