Beleodaq Injection and Cefotaxime Sodium

• Generic Name: belinostat
• Dosage Forms: injection, powder, lyophilized, for solution
• Other Brand Names: Beleodaq

Belinostat is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Belinostat is used to treat peripheral T-cell lymphoma that has relapsed or has not responded to other treatments.

Belinostat was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, non-small cell lung tumors responded to belinostat. However, it has not been shown that belinostat can improve symptoms or lengthen survival time.

Belinostat may also be used for purposes not listed in this medication guide.

• Generic Name: cefotaxime
• Dosage Forms: n.a.
• Other Brand Names: Claforan, Claforan ADD-Vantage

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

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.

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

Treatment of gastroenteritis caused by Salmonella. (See Typhoid Fever and Other Salmonella Infections under Uses.)

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

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.

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. 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.

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).

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).

Treatment of meningitis and ventriculitis caused by susceptible H. influenzae, N. meningitidis, S. pneumoniae, E. coli, or K. pneumoniae.

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

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

Treatment of serious lower respiratory tract infections, including community-acquired pneumonia (CAP) 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).

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. Also recommended in certain combination regimens used for empiric treatment of CAP. 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).

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).

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).

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

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.

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.

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).

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

Alternative for treatment of uncomplicated cervical, urethral, or rectal gonorrhea caused by susceptible Neisseria gonorrhoeae in adults or adolescents. Drug of choice is IM ceftriaxone. 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.

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

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

Treatment of early neurologic Lyme disease with acute neurologic manifestations such as meningitis or radiculopathy. IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G. 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, a parenteral regimen usually is recommended when there are acute neurologic manifestations.

Treatment of Lyme carditis when a parenteral regimen is indicated. IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G. 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.

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

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

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

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.

Alternative for treatment of Salmonella gastroenteritis in HIV-infected individuals to prevent extraintestinal spread of the infection. 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. Depending on in vitro susceptibility, alternatives are co-trimoxazole or third generation cephalosporins (ceftriaxone, cefotaxime).

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

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

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

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. Other anti-infectives (e.g., cefazolin) usually recommended for these procedures.

First or second generation cephalosporins (cefazolin, cefotetan, cefoxitin, cefuroxime) generally preferred when a cephalosporin is used for perioperative prophylaxis. 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.