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, 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.

Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis [Recruiting]
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.

The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.

Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis [Recruiting]
This phase III multicentric international randomized trial is designed to compare the efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical or confirmed late-onset sepsis (LOS).

The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well known and documented in this population.

Clinical Trial Corticoids ForO Empyema And Pleural Eeffusion In Children [Recruiting]
STUDY JUSTIFICATION

1. Scientific evidence of the usefulness of corticosteroid use for infectious diseases: Corticosteroids along with antibiotic use improve survival in some infectious processes provide long term benefits and improve symptoms in many others.

2. Clinical Observation: the investigators observed that patients with parapneumonic pleural effusion and associated bronchospasm who were treated with corticosteroids for their bronchospasm, evolved to healing before patients who were not treated with corticosteroids (average admission days 10 vs. 17).

3. Rationale: the anti-inflammatory effect has been the rationale for the use of Dexametasone as an inhibitor of the inflammatory response observed after the first dose of parenteral antibiotic in bacterial meningitis. A similar effect is likely to occur in pneumonia with pleural effusion. It can be therefore hypothesized that Dexametasone could inhibit an excessive inflammatory response by mesothelial and inflammatory cells during the early phases of parapneumonic empyema, reducing its severity and hence its complications.

OBJECTIVES

1. Principal: to investigate if Dexametasone 0,25mg/kg q. i.d. added to standard antibiotic therapy reduces time to resolution of parapneumonic pleural effusion.

2. Secondary:

2. 1. Evaluate the effect of Dexametasone 0,25mg/kg q. i.d. added to standard antibiotic therapy on the development of complications during pleural effusion episode.

2. 2. Evaluate the incidence of severe and non severe adverse events associated with the new treatment versus standard therapy.

METHODS

1. Study design: exploratory (pilot), randomized, double blinded, placebo controlled, parallel stratified design, multicentric.

2. Participating Hospitals (n=56, 7 patients per center):

- Hospital Infanta Sofía (S. Sebastián de los Reyes, Madrid).

- Hospital Universitario de Getafe

- Hospital Universitario Ramón y Cajal, Madrid.

- Hospital Universitario Materno-Infantil Carlos Haya, Málaga.

- Hospital Infantil La Paz, Madrid.

- Hospital U. Gregorio Marañón

- Hospital U. Príncipe de Asturias

- Hospital Virgen de la Salud, Toledo

3. Endpoints:

3. 1. Primary: time to resolution. 3. 2. Secondary endpoints:

1. Effectiveness: number of children with complications.

2. Safety (expected number: none). i) Hyperglycemia ii) Signs of gastrointestinal bleeding iii) Need of transfusion iv) Oropharingeal Candidiasis v) Allergic reaction vi) Other adverse reactions described in the Medication Guide.

4. Treatment arms:

3. 1. Control (0)

- Normal saline 0,6 ml/kg, IV, q. i.d. for 2 days.

- Cefotaxime 150 mg/kg, IV, q. d. until discharge criteria are present.

- Ranitidine 5 mg/kg IV, q. d. for 2 days.

- Amoxicillin- Clavulanic acid 80mg/kg p. o., q. d. during 15 days.

3. 2. Study treatment: (1)

- Dexametasone 0,25mg/kg, IV, q. i.d. for 2 days.

- Cefotaxime 150 mg/kg, IV, q. d. until discharge criteria are present

- Ranitidine 5 mg/kg IV, q. d. for 2 days

- Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days.

4. INCLUSION CRITERIA

- Patients between 1 and 14 year old.

- Presence of pneumonia diagnosed by clinical and radiographic criteria: cough, fever and

radiological consolidation.

- Evidence of pleural effusion.

Cerebral Antibiotics Distribution After Acute Brain Injury [Recruiting]

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Reports of Suspected Claforan (Cefotaxime) Side Effects

Drug Rash With Eosinophilia and Systemic Symptoms (22),  Agranulocytosis (9),  Pyrexia (6),  Acute Generalised Exanthematous Pustulosis (6),  Lymphopenia (5),  Lymphadenopathy (4),  Stevens-Johnson Syndrome (4),  Eosinophilia (4),  Neutropenia (4),  Confusional State (3), more >>