Mefoxin (Cefoxitin Sodium Injection) - Summary

MEFOXIN SUMMARY

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MEFOXIN (Cefoxitin for Injection) is a semi-synthetic, broad-spectrum cepha antibiotic sealed under nitrogen for intravenous administration. It is derived from cephamycin C, which is produced by Streptomyces lactamdurans.

MEFOXIN is indicated for the following:

Treatment

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

1. Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae, other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species.
2. Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri).
3. Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species.
4. Gynecological infections, including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli, Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Streptococcus agalactiae. MEFOXIN, like cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when MEFOXIN is 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.
5. Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis.
6. Bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains).
7. Skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes and other streptococci (excluding enterococci e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Escherichia coli, Proteus mirabilis, Klebsiella species, Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, and Peptostreptococcus species.

Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to MEFOXIN. Therapy may be started while awaiting the results of these studies.

In randomized comparative studies, MEFOXIN and cephalothin were comparably safe and effective in the management of infections caused by gram-positive cocci and gram-negative rods susceptible to the cephalosporins. MEFOXIN has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases.

Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to MEFOXIN. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with MEFOXIN. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with MEFOXIN.

Prevention

MEFOXIN is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section.

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

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MEFOXIN and other antibacterial drugs, MEFOXIN 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 Mefoxin (Cefoxitin)

Failure of cefoxitin and doxycycline to eradicate endometrial Mycoplasma genitalium and the consequence for clinical cure of pelvic inflammatory disease. [2008.10]
OBJECTIVES: As Mycoplasma genitalium is associated with pelvic inflammatory disease (PID), we examined the efficacy of a commonly used PID antimicrobial in treating M genitalium upper genital tract infection... CONCLUSIONS: M genitalium is associated with endometritis and short-term PID treatment failure. Cefoxitin and doxycycline, a Centers for Disease Control and Prevention recommended PID treatment regimen, is ineffective for the treatment of M genitalium upper genital tract infection.

Ampicillin/sulbactam and cefoxitin in the treatment of cutaneous and other soft-tissue abscesses in patients with or without histories of injection drug abuse. [2000.08]
A randomized, double-blind trial compared the clinical and bacteriologic efficacy of ampicillin/sulbactam (2 g/1 g) and cefoxitin (2 g) administered intravenously every 6 h to patients with (n=49) or without (n=47) histories of injection drug abuse who presented with cutaneous or other soft-tissue infections...

The effects of sodium ampicillin, sodium cefazolin, and sodium cefoxitin on blood pressures and heart rates in healthy, anesthetized dogs. [2000.03]
This study determined the effects of intravenous ampicillin, cefazolin, and cefoxitin on blood pressures and heart rates in healthy, anesthetized dogs. Forty dogs were each randomly assigned to a control, ampicillin, cefazolin, or cefoxitin group...

Pharmacoeconomic analysis of ampicillin-sulbactam versus cefoxitin in the treatment of intraabdominal infections. [1998.01]
We conducted a retrospective pharmacoeconomic analysis of a prospective, multicenter, double-blind, randomized, controlled trial comparing the beta-lactamase inhibitor combination ampicillin-sulbactam (96 patients) and the cephalosporin cefoxitin (101) in the treatment of intraabdominal infections...

[Prospective and comparative study of cefoxitin and ceftizoxime in appendicitis surgery] [1997.09]
OBJECTIVE: Acute appendicitis is the most common acute surgical disease in childhood and it still presents frequent septic complications. This prospective and randomized study compares the efficacy of two cephalosporins (cefoxitin and ceftizoxime) in terms of clinical response, in vitro activity and characteristics of use in clinical practice... CONCLUSIONS: We conclude that ceftizoxime is as effective as cefoxitin and can be surely employed in the treatment of acute appendicitis in children. Its addition, its longer half-life simplifies its use in clinical practice.

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Clinical Trials Related to Mefoxin (Cefoxitin)

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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