|Manufacturer:||Wyeth Pharmaceuticals, Inc.|
|Other Info:||PIPRACIL is stable in both glass and plastic containers when reconstituted with recommended diluents and when diluted with the intravenous solutions and intravenous admixtures indicated above.Pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20° to 25°C [68° to 77°F]), or after 48 hours if stored at refrigerated temperature (2° to 8°C [36° to 46°F]). Vials should not be frozen after reconstitution.|
Therapeutic: PIPRACIL is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:Intra-Abdominal Infections including hepatobiliary and surgical infections caused by E.
coli, Pseudomonas aeruginosa, enterococci, Clostridium spp., anaerobic cocci, or Bacteroides spp., including B.
fragilis.Urinary Tract Infections caused by E.
coli, Klebsiella spp., P.
aeruginosa, Proteus spp., including P.
mirabilis, or enterococci.Gynecologic Infections including endometritis, pelvic inflammatory disease, pelvic cellulitis caused by Bacteroides spp., including B.
fragilis, anaerobic cocci, Neisseria gonorrhoeae, or enterococci (E.
Septicemia including bacteremia caused by E.
coli, Klebsiella spp., Enterobacter spp., Serratia spp., P.
pneumoniae, enterococci, P.
aeruginosa, Bacteroides spp., or anaerobic cocci.Lower RespiratoryTract Infections caused by E.
coli, Klebsiella spp., Enterobacter spp., P. aeruginosa, Serratia spp., H.
influenzae, Bacteroides spp., or anaerobic cocci. Although improvement has been noted in patients with cystic fibrosis, lasting bacterial eradication may not necessarily be achieved.Skin and Skin Structure Infections caused by E.
coli, Klebsiella spp., Serratia spp., Acinetobacter spp., Enterobacter spp., P.
aeruginosa, Morganella morganii, Providencia rettgeri, Proteus vulgaris, P.
mirabilis, Bacteroides spp., including B.
fragilis, anaerobic cocci, or enterococci.Bone and Joint Infections caused by P.
aeruginosa, enterococci, Bacteroides spp., or anaerobic cocci.Uncomplicated Gonococcal Urethritis caused by N.
gonorrhoeae.PIPRACIL has also been shown to be clinically effective for the treatment of infections at various sites caused by Streptococcus species including S.
pyogenes and S.
pneumoniae; however, infections caused by these organisms are ordinarily treated with more narrow spectrum penicillins.
Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, PIPRACIL is particularly useful for the treatment of mixed infections and presumptive therapy prior to the identification of the causative organisms.
Also, PIPRACIL may be administered as single drug therapy in some situations where normally two antibiotics might be employed.Piperacillin has been successfully used with aminoglycosides, especially in patients with impaired host defenses.
Both drugs should be used in full therapeutic doses.Appropriate cultures should be made for susceptibility testing before initiating therapy and therapy adjusted, if appropriate, once the results are known.Prophylaxis: PIPRACIL is indicated for prophylactic use in surgery including intra-abdominal (gastrointestinal and biliary) procedures, vaginal hysterectomy, abdominal hysterectomy, and cesarean section.
Effective prophylactic use depends on the time of administration; PIPRACIL should be given one-half to one hour before the operation so that effective levels can be achieved in the site prior to the procedure.The prophylactic use of piperacillin should be stopped within 24 hours, since continuing administration of any antibiotic increases the possibility of adverse reactions, but in the majority of surgical procedures, does not reduce the incidence of subsequent infections. If there are signs of infection, specimens for culture and susceptibility testing should be obtained for identification of the causative microorganism so that appropriate therapy can be instituted.To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIPRACIL and other antibacterial drugs, PIPRACILshould only be used 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.
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC/ANAPHYLACTOID) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY.
THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.
THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS.
BEFORE INITIATING THERAPY WITH PIPRACIL, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS.
IF AN ALLERGIC REACTION OCCURS, PIPRACIL SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED.
SERIOUS ANAPHYLACTIC/ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including PIPRACIL, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.difficile, and surgical evaluation should be instituted as clinically indicated.