Pronunciation: seff-oh-TAX-eem SO-dee-uhm
- Powder for injection 500 mg
- Powder for injection 1 g
- Powder for injection 2 g
- Powder for injection 10 g
- Injection 1 g
- Injection 2 g
Inhibits mucopeptide synthesis in bacterial cell wall.
C max is 11.7 mcg/mL (500 mg dose) and 20.5 mcg/mL (1 g dose). T max is about 0.5 h.
Cefotaxime is metabolized to desacetyl derivative (active).
About 60% is recovered in the urine in 6 h; about 20% to 36% is excreted as unchanged cefotaxime and 15% to 25% as desacetyl derivative. The t ½ is 60 min (adults); 3 to 5 h (infants).
Indications and Usage
Treatment of infections of lower respiratory tract including pneumonia, urinary tract, skin and skin structures, bone and joints; treatment of bacteremia/septicemia, CNS infections, intra-abdominal infections including peritonitis, gynecological infections including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by susceptible strains of specific microorganisms; perioperative prophylaxis.
Hypersensitivity to cephalosporins.
Dosage and AdministrationInfection
IV/IM Up to 12 g/day in divided doses (from every 4 h for septicemia to every 12 h for uncomplicated infection) usually for 7 to 10 days. IV route is preferable for severe infections.Children 1 mo to 12 yr of age (weighing less than 50 kg)
IV/IM 50 to 180 mg/kg/day in 4 to 6 divided doses.Children 1 mo to 12 yr of age (weighing more than 50 kg)
Usual adult dose (max, 12 g/day).Infants 1 to 4 wk of age
IV 50 mg/kg every 8 h.Newborns younger than 1 wk of age
IV 50 mg/kg every 12 h.Gonococcal Urethritis/Cervicitis in Men and Women
IM 0.5 g as single dose.Rectal Gonorrhea
IM 0.5 g as single dose (women); 1 g as single dose (men).Perioperative Prophylaxis
IV/IM 1 g 30 to 90 min prior to surgery.Cesarean Section
IV 1 g as soon as umbilical cord is clamped; second and third dose IV/IM at 6- and 12-h intervals after first dose.Dosage Adjustment for Renal Function Impairment
Reduce dose 50% in patients with Ccr less than 20 mL/min.
- For IM or IV administration only. Not for intradermal, subcutaneous, or intra-arterial administration.
- IV route preferred for severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance.
- Follow manufacturer's guidelines for reconstitution of sterile powder with respect to diluent volume, withdrawable volume, and approximate final concentration.
- For IM administration, reconstitute vials with sterile water for injection or bacteriostatic water for injection.
- For IV administration, reconstitute vials with at least 10 mL sterile water for injection; reconstitute infusion bottles with 50 or 100 mL sodium chloride 0.9% injection or dextrose 5% injection.
- Shake to dissolve.
- Thaw premixed frozen injection at room temperature or under refrigeration (at or below 41°F). Do not force thaw by immersion in water baths or microwave irradiation. Check container for minute leaks by squeezing container firmly. Discard container if leaks are detected. Do not use plastic containers in series connections because of risk of air embolism.
- Reconstituted or thawed solution should be clear and pale to light yellow in color. Do not use if discolored, cloudy, or contains particulate matter.
- Intermittent IV administration: solution containing 1 or 2 g cefotaxime in 10 mL sterile water for injection can be injected over a period of 3 to 5 min. Do not administer over a period of less than 3 min. Can also be administered via infusion system over longer period of time; temporarily discontinue administration of other solutions at same site during infusion of cefotaxime.
- For continuous IV infusion, add solution of cefotaxime to IV bottles containing compatible fluids (sodium chloride 0.9% injection, dextrose 5% or 10% injection, dextrose 5% and sodium chloride 0.9%, 0.45%, or 0.2% injection, Ringer's lactate solution, sodium lactate injection, invert sugar 10% solution, Travasol 8.5% amino acid injection without electrolytes.
- For IM administration. Dose of 2 g may be given if dose is divided and administered at different sites.
Store vials and bottles of dry powder below 86°F. Protect from light and excessive temperature. Refer to manufacturer's guidelines for storage and stability recommendations for reconstituted solutions. Store premixed frozen injection in freezer capable of maintaining temperature of −4°F. Thawed solution is stable for 10 days under refrigeration (at or below 41°F) or 24 h at or below 72°F. Do not refreeze thawed antibiotics.
Increased risk of nephrotoxicity.
Do not add aminoglycosides to cefotaxime solutions because inactivation of both drugs may result; administer at separate sites if concurrent therapy is indicated.
Laboratory Test Interactions
False-positive direct Coombs test results in certain patients (eg, those with azotemia).
Colitis, diarrhea, nausea, vomiting (at least 1%); pseudomembranous colitis symptoms can occur during or after treatment.
Rash, pruritus, fever, eosinophilia, urticaria, anaphylaxis (at least 1%).
Injection-site inflammation with IV administration; pain and induration, tenderness after IM administration (at least 1%).
Review results of culture and sensitivity testing as appropriate. Ensure that cefotaxime is discontinued and another antimicrobial agent is started if sensitivity tests indicate that the organism is resistant to cefotaxime.
Category B .
Excreted in breast milk.
Because elderly patients are more likely to have decreased renal function, use care in dose selection and consider monitoring renal function.
Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-reactivity.
Use with caution. Reduce dose when Ccr is less than 20 mL/min.
May result in bacterial or fungal overgrowth of nonsusceptible microorganisms.
Use with caution, especially in patients with history of colitis.
Granulocytopenia, and more rarely, agranulocytosis, may develop during treatment with cefotaxime, particularly if given over long periods. Monitor CBC during course of treatment lasting longer than 10 days.
May be locally irritating to tissues in the event of extravasation. Regularly monitor infusion sites and change when appropriate.
Consider in patients in whom diarrhea develops.
Elevated BUN and creatinine.
- Advise patient or caregiver that medication will be prepared by a health care provider and administered in a health care setting.
- Review dosing schedule and prescribed length of therapy with patient. Advise patient that route of administration, dose, dosing frequency, and duration of therapy are dependent on site of infection, severity of infection, and response to treatment.
- Advise patient or caregiver to immediately inform health care provider if injection-site pain or redness, skin rash, hives, itching, or shortness of breath occur during treatment.
- Advise patient or caregiver to report signs of superinfection to health care provider: black furry tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
- Warn patient or caregiver that diarrhea containing blood or pus may be a sign of a serious disorder and, if noted after discharge, to seek medical care if noted and not to treat at home.
Copyright © 2009 Wolters Kluwer Health.