Claforan

Name: Claforan

Claforan Precautions

Serious side effects have been reported with Claforan including the following:

  • hypersensitivity (severe allergic reaction). Signs of a hypersensitivity reaction, which include the following:
    • chest pain
    • swelling of the face, eyes, lips, tongue, arms, or legs
    • difficulty breathing or swallowing
    • fainting
    • rash
  • diarrhea. Diarrhea is a common problem caused by antibiotics, and it usually ends when the antibacterial 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 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, contact your doctor, as this may be a sign of an infection of the bowels.
  • superinfection. Claforan should not be used for extended periods. Prolonged use can lead to the growth of dangerous organisms that are resistant or unresponsive to this medication. Take Maxipime for the duration prescribed by your doctor.

Do not take Claforan if you:

  • are allergic to Claforan or to any of its ingredients
  • are allergic to similar antibiotics (penicillins, cephalosporins)

Inform MD

Before taking Claforan, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Claforan or to any of its ingredients
  • are allergic to similar antibiotics (penicillins, cephalosporins)
  • have any other type of allergy
  • have gastrointestinal (stomach and bowel) problems, especially colitis
  • have kidney problems
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

How should I use Claforan (cefotaxime)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Cefotaxime is injected into a muscle or into a vein through an IV. It is sometimes given through a central IV line placed into a large vein in your chest. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Cefotaxime must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Cefotaxime will not treat a viral infection such as the flu or a common cold.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using cefotaxime.

If your medicine is frozen when you receive it, keep it frozen until you are ready to use the medicine. It is best to store the medicine in a deep freezer at a temperature of 4 degrees below 0.

To use the medicine, thaw it in a refrigerator or at room temperature. Do not warm in a microwave or boiling water. Keep thawed medicine in the refrigerator and use it within 10 days after thawing it. Do not refreeze thawed medicine.

What other drugs will affect Claforan (cefotaxime)?

Cefotaxime can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with cefotaxime, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Uses for Claforan

Bone and Joint Infections

Treatment of serious bone and joint infections caused by susceptible S. aureus, streptococci (including S. pyogenes), Pseudomonas (including Ps. aeruginosa), or P. mirabilis.230

Genitourinary Tract Infections

Treatment of serious genitourinary tract infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, enterococci, Citrobacter, Enterobacter, E. coli, Klebsiella, Morganella morganii, P. mirabilis, P. vulgaris, Providencia stuartii, P. rettgeri, Pseudomonas (including Ps. aeruginosa), or S. marcescens.230

GI Infections

Empiric treatment of infectious diarrhea†.412 Alternative for empiric treatment of severe diarrhea in HIV-infected individuals; ciprofloxacin is drug of choice.412

Treatment of gastroenteritis caused by Salmonella†.197 245 275 412 (See Typhoid Fever and Other Salmonella Infections under Uses.)

Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis†.218 245 275 Usually self-limited infections, but anti-infectives may be indicated in immunocompromised individuals, for severe infections, or when septicemia or other invasive disease occurs.218 245 275

Gynecologic Infections

Treatment of gynecologic infections (including pelvic inflammatory disease [PID], endometritis, pelvic cellulitis) caused by susceptible S. epidermidis, streptococci (including enterococci), E. coli, Enterobacter, Klebsiella, P. mirabilis, Bacteroides (including B. fragilis), Clostridium, Fusobacterium (including F. nucleatum), Peptococcus, and Peptostreptococcus.230

When parenteral regimen is used for treatment of PID, CDC recommends IV cefoxitin or cefotetan given in conjunction with oral doxycycline or IV clindamycin given in conjunction with gentamicin.167 While other parenteral cephalosporins (e.g., cefotaxime, ceftriaxone) also may be effective, CDC states these drugs are less active than cefoxitin or cefotetan against anaerobic bacteria.167

When oral regimen is used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or cefotaxime given in conjunction with oral doxycycline (with or without oral metronidazole).167

Intra-abdominal Infections

Treatment of serious intra-abdominal infections (including peritonitis) caused by susceptible streptococci, E. coli, Klebsiella, P. mirabilis, Clostridium, Bacteroides, or anaerobic cocci (including Peptococcus and Peptostreptococcus).230

Meningitis and Other CNS Infections

Treatment of meningitis and ventriculitis caused by susceptible H. influenzae, N. meningitidis, S. pneumoniae,230 275 291 294 296 335 E. coli, or K. pneumoniae.230 275 291 294 296 336

A drug of choice when a third generation cephalosporin is indicated for empiric treatment of bacterial meningitis;275 290 296 319 should not be used alone for empiric treatment when Listeria monocytogenes, enterococci, staphylococci, or Ps. aeruginosa may be involved.275 290 296 319

Treatment of brain abscesses and other CNS infections† (e.g., subdural empyema, intracranial epidural abscesses).319 336 347 Concomitant metronidazole usually recommended for empiric therapy;319 347 used in conjunction with a penicillinase-resistant penicillin or vancomycin if staphylococci suspected.319 347

Respiratory Tract Infections

Treatment of serious lower respiratory tract infections, including community-acquired pneumonia (CAP)197 269 342 caused by susceptible Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), other streptococci (except enterococci), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella, Haemophilus influenzae (including ampicillin-resistant strains), H. parainfluenzae, Proteus mirabilis, indole-positive Proteus, Serratia marcescens, Enterobacter, or Pseudomonas (including Ps. aeruginosa).230

Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae and as a preferred drug for treatment of CAP caused by penicillin-resistant S. pneumoniae, provided in vitro susceptibility has been demonstrated.269 Also recommended in certain combination regimens used for empiric treatment of CAP.269 Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).269

For empiric inpatient treatment of CAP in patients not requiring treatment in an intensive care unit (non-ICU patients), IDSA and ATS recommend monotherapy with a fluoroquinolone (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam (usually cefotaxime, ceftriaxone, or ampicillin) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin).269

For empiric inpatient treatment of CAP in ICU patients when Pseudomonas and oxacillin-resistant (methicillin-resistant) S. aureus are not suspected, IDSA and ATS recommend a combination regimen that includes a β-lactam (cefotaxime, ceftriaxone, fixed combination of ampicillin and sulbactam) given in conjunction with either azithromycin or a fluoroquinolone (moxifloxacin, gemifloxacin, levofloxacin).269

Septicemia

Treatment of bacteremia/septicemia caused by E. coli, Klebsiella, S. marcescens, S. aureus, or streptococci (including S. pneumoniae).230 An aminoglycoside often is used concomitantly.230

Select anti-infective for treatment of sepsis syndrome based on probable source of infection, causative organism, immune status of patient, and local patterns of bacterial resistance.197

For initial treatment of life-threatening sepsis in adults, some clinicians suggest that a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftriaxone, ceftazidime), the fixed combination of piperacillin and tazobactam, or a carbapenem (doripenem, imipenem, meropenem) be used in conjunction with vancomycin; some also suggest including an aminoglycoside or fluoroquinolone during initial few days of treatment.197

Skin and Skin Structure Infections

Treatment of serious skin and skin structure infections caused by susceptible S. aureus, S. epidermidis, S. pyogenes, other streptococci (including enterococci), Acinetobacter, E. coli, Citrobacter (including C. freundii), Enterobacter, Klebsiella, P. mirabilis, P. vulgaris, M. morganii, P. rettgeri, Pseudomonas, Serratia, Bacteroides (including B. fragilis), Fusobacterium (including F. nucleatum), or anaerobic cocci (including Peptococcus and Peptostreptococcus).230

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga† (e.g., septicemia, meningitis, endocarditis).197

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated cervical, urethral, or rectal gonorrhea caused by susceptible Neisseria gonorrhoeae in adults or adolescents.167 230 275 366 367 Drug of choice is IM ceftriaxone.167 275 Although IM cefotaxime may be effective for urogenital and anorectal gonorrhea, CDC states it offers no advantages over IM ceftriaxone and has uncertain efficacy for pharyngeal gonorrhea.167

Alternative for initial treatment of disseminated gonococcal infections† caused by susceptible N. gonorrhoeae.167 275 Ceftriaxone is drug of choice for initial parenteral treatment of disseminated gonorrhea in adults, adolescents, or children.167 275

Treatment of disseminated gonococcal infections†,167 275 gonococcal scalp abscesses†,167 275 and gonococcal ophthalmia neonatorum† in neonates.167 275

Lyme Disease

Treatment of early neurologic Lyme disease† with acute neurologic manifestations such as meningitis or radiculopathy.273 275 351 354 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.273 275 351 354 Although an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) may be effective for early localized or early disseminated Lyme disease associated with erythema migrans in the absence of specific neurologic manifestations or advanced atrioventricular (AV) heart block,270 273 275 284 285 286 287 338 351 353 355 356 357 a parenteral regimen usually is recommended when there are acute neurologic manifestations.270 273 275 284 285 286 287 338 351 353 355 356

Treatment of Lyme carditis† when a parenteral regimen is indicated.273 275 351 354 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.273 275 351 354 Although a parenteral regimen usually is recommended for initial treatment of hospitalized patients, an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) can be used to complete therapy and for the treatment of outpatients.273 275 351 354

Treatment of Lyme arthritis† when a parenteral regimen is indicated.273 275 351 354 361 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.273 275 351 354 361 Although the comparative safety and efficacy of oral versus IV anti-infectives for treatment of Lyme arthritis have not been fully evaluated,351 those with concomitant neurologic disease generally should receive a parenteral regimen.273 275 351 354 361

Treatment of late neurologic Lyme disease† affecting the CNS or peripheral nervous system (e.g., encephalopathy, neuropathy).351 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.351

Typhoid Fever and Other Salmonella Infections

Treatment of typhoid fever (enteric fever) or septicemia caused by Salmonella typhi or S. paratyphi†, including multidrug-resistant strains.275 306

Treatment of gastroenteritis caused by Salmonella† (e.g., S. enteritidis, S. typhimurium) in individuals with severe Salmonella gastroenteritis and in those who are at increased risk of invasive disease.197 245 275 412

Alternative for treatment of Salmonella gastroenteritis in HIV-infected individuals to prevent extraintestinal spread of the infection.412 CDC, NIH, and IDSA recommend ciprofloxacin as drug of choice for treatment of Salmonella gastroenteritis (with or without bacteremia) in HIV-infected adults; other fluoroquinolones (levofloxacin, moxifloxacin) also may be effective.412 Depending on in vitro susceptibility, alternatives are co-trimoxazole or third generation cephalosporins (ceftriaxone, cefotaxime).412

Vibrio Infections

Treatment of severe Vibrio parahaemolyticus† infection when anti-infective therapy is indicated in addition to supportive care.218

Treatment of infections caused by V. vulnificus†.197 250 Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended.197 218 250 Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.250 294

Perioperative Prophylaxis

Has been used for perioperative prophylaxis in patients undergoing liver transplantation†; some experts recommend a regimen of cefotaxime and ampicillin for such prophylaxis.169

Has been used for perioperative prophylaxis to reduce the incidence of infection in patients undergoing contaminated or potentially contaminated surgery (e.g., biliary tract, colorectal, other intra-abdominal or GI surgery, genitourinary surgery, abdominal or vaginal hysterectomy) and in patients undergoing cesarean section.169 230 Other anti-infectives (e.g., cefazolin) usually recommended for these procedures.168 169

First or second generation cephalosporins (cefazolin, cefotetan, cefoxitin, cefuroxime) generally preferred when a cephalosporin is used for perioperative prophylaxis.168 169 Third generation cephalosporins (cefotaxime, ceftriaxone, ceftazidime) and fourth generation cephalosporins (cefepime) not usually recommended for perioperative prophylaxis since they are expensive, some are less active against staphylococci than first or second generation cephalosporins, they have wider spectrums of activity than necessary for organisms encountered in elective surgery, and their use for prophylaxis may promote emergence of resistant organisms.168 169

Precautions While Using Claforan

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Cefotaxime injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Cefotaxime injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Before you or your child have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Uses of Claforan

  • It is used to treat or prevent bacterial infections.

What are some things I need to know or do while I take Claforan?

  • Tell all of your health care providers that you take Claforan. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
  • If you have high blood sugar (diabetes), do not use Clinitest®. Use some other urine glucose testing like Clinistix® or Tes-Tape®.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Claforan.
  • Do not use longer than you have been told. A second infection may happen.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Claforan while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Claforan?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Indications and Usage for Claforan

Treatment

Claforan is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.

(1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes3 (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens3, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).

(2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus3, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris3, Providencia stuartii, Morganella morganii3, Providencia rettgeri3, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains.

(3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species3, Klebsiella species3, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis3), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum3).
Claforan, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.

(4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia).

(5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species3, Escherichia coli, Citrobacter species (including C. freundii3), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris3, Morganella morganii, Providencia rettgeri3, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus3 species and Peptococcus species).

(6) Intra-abdominal infections including peritonitis caused by Streptococcus species3, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus3 species and Peptococcus3 species) Proteus mirabilis3, and Clostridium species3.

(7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes3), Pseudomonas species (including P. aeruginosa3), and Proteus mirabilis3.

(8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae3 and Escherichia coli3.

Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, Claforan has been used successfully in treating patients with infections caused by susceptible organisms.

Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to Claforan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Claforan may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if Claforan is used concomitantly with an aminoglycoside.

3 Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections.

Prevention

The administration of Claforan preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated.

In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of Claforan may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section.

Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, Claforan should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section.

For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended.

If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Claforan and other antibacterial drugs, Claforan should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

Claforan is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.

Overdosage

The acute toxicity of Claforan was evaluated in neonatal and adult mice and rats. Significant mortality was seen at parenteral doses in excess of 6000 mg/kg/day in all groups. Common toxic signs in animals that died were a decrease in spontaneous activity, tonic and clonic convulsions, dyspnea, hypothermia, and cyanosis. Cefotaxime sodium overdosage has occurred in patients. Most cases have shown no overt toxicity. The most frequent reactions were elevations of BUN and creatinine. There is a risk of reversible encephalopathy in cases of administration of high doses of beta-lactam antibiotics including cefotaxime. No specific antidote exists. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

References

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. 2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobials Susceptibility Tests; Twenty-Fifth Informational Supplement. CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. 3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. 4. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard - Eighth Edition. CLSI document M11-A8, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012. 5. Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31-41, 1976.

Revised March 2015

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

Claforan Injection in Galaxy® Containers:

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

© 2015 sanofi-aventis U.S. LLC

Galaxy, Travasol and Viaflex are registered trademarks of Baxter International Inc.

PRINCIPAL DISPLAY PANEL - 500mg Vial Carton

NDC 0039-0017-10

Claforan® Sterile
cefotaxime for injection, USP

500mg

FOR IM/IV ADMINISTRATION

Ten 500mg Vials

sanofi aventis

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