Claforan (Cefotaxime Sodium) - Summary

CLAFORAN SUMMARY

CLAFORAN^®
Sterile (cefotaxime for injection, USP)
and
Injection (cefotaxime injection, USP)

Sterile CLAFORAN® (cefotaxime sodium) is a semi-synthetic, 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 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 pyogenes * (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 marcescens *, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).
2. Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus *, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris *, Providencia stuartii, Morganella morganii *, Providencia rettgeri *, 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 species *, Klebsiella species *, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis *), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum *).
   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 antichlamydial 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 species *, Escherichia coli, Citrobacter species (including C. freundii *), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris *, Morganella morganii, Providencia rettgeri *, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus * species and Peptococcus species).
6. Intra-abdominal infections including peritonitis caused by Streptococcus species *, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus * species and Peptococcus * species) Proteus mirabilis *, and Clostridium species *.
7. Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes *), Pseudomonas species (including P. aeruginosa *), and Proteus mirabilis *.
8. Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae * and Escherichia coli *.

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.

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NEWS HIGHLIGHTS

Published Studies Related to Claforan (Cefotaxime)

Single daily amikacin versus cefotaxime in the short-course treatment of spontaneous bacterial peritonitis in cirrhotics. [2005.11.21]
CONCLUSION: In this study, single daily doses of amikacin in the treatment of SBP in cirrhotics were not associated with an increased incidence of renal impairment or nephrotoxicity. However, a 5-d regimen of amikacin is less effective than a 5-d regimen of cefotaxime in the SBP treatment.

The impact of catheter-restricted filling with cefotaxime and heparin on the lifespan of temporary hemodialysis catheters: a case controlled study. [2005.11]
BACKGROUND: Reduction in the rates of major complications such as infection and thrombosis that limit the lifespan of hemodialysis (HD) catheters could conceivably lead to improved survival of "temporary" non-tunneled HD catheters (NTCs). This study was designed to evaluate the impact of the "locking"' of a broad-spectrum antibiotic-cefotaxime with heparin, on the incidence of catheter thrombosis, catheter-related bloodstream infections (CRBSI) and the NTC lifespan... CONCLUSIONS: Cefotaxime-heparin locks led to a significant reduction in catheter thrombosis and CRBSI incidence. The enhanced NTC lifespan thus achieved could help physicians in better assessment of the patient's vasculature prior to the placement of permanent vascular access.

Cefotaxime and ceftriaxone cerebrospinal fluid levels during treatment of bacterial meningitis in children. [2005.11]
Cefotaxime (CTX) and ceftriaxone (CRO) were compared for cerebrospinal fluid (CSF) penetration and antimicrobial efficacy in cases of bacterial meningitis in children. This was a comparative study of CRO (100mg/kg once daily) and CTX (50 mg/kg 6 hourly) in the treatment of children with bacterial meningitis...

[Incidence of infected surgical wound and prophylaxis with cefotaxime in cesarean section] [2005.10]
BACKGROUND: Surgical wound infection after cesarean section varies from 2.5 to 16.1%, thus the utilization of antibiotic prophylaxis has increased routinely and irrationally. Despite this, we can still see cases of infections... Then, the cases with risk factors should be analyzed carefully for the cefotaxime administration.

Comparison of levofloxacin and cefotaxime combined with ofloxacin for ICU patients with community-acquired pneumonia who do not require vasopressors. [2005.07]
STUDY OBJECTIVES: To evaluate the efficacy and tolerability of levofloxacin (L) as monotherapy in patients with severe community-acquired pneumonia (CAP) in comparison with therapy using a combination of cefotaxime (C) plus ofloxacin (O)... CONCLUSION: L therapy was at least as effective as the combination therapy of C + O in the treatment of a subset of patients with CAP requiring ICU admission. This conclusion cannot be extrapolated to patients requiring mechanical ventilation or vasopressors (ie, those patients in shock).

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Clinical Trials Related to Claforan (Cefotaxime)

Effect of Genetic Variation in the Transporter, OAT3, on the Renal Secretion of Cefotaxime [Recruiting]
In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3.

Tissue Penetration of Antibiotics in Obesity [Recruiting]

Study of Conservative Versus Surgical Treatment of Appendicitis [Active, not recruiting]
The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. Our hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.

Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs [Active, not recruiting]
This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.

Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis [Recruiting]
Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality.

Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin.

It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0. 83 +/- 0. 09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p<0. 0001). These results suggest that the development of renal failure in patients with cirrhosis and bacterial infections different from SBP, associated with signs of a systemic inflammatory response, is very frequent and results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to consider these patients as candidates for liver transplantation and to plan strategies for its prevention.

The objective of this project, therefore, is to evaluate if the plasma volume expansion with albumin, associated with conventional antibiotic therapy, can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis.

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