ections 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.

f 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.

and children <40 kg (88 lbs) other recommendations oxacillin 250 to 500 mg iv every 4 to 6 hours (mild to moderate infections) 50 mg/kg/day iv in equally divided doses every 6 hours (mild to moderate infections) 1 gram iv every 4 to 6 hours (severe infections) 100 mg/kg/day iv in equally divided doses every 4 to 6 hours (severe infections) premature and neonates 25 mg/kg/day iv directions for use for administration by intravenous infusion reconstitute as directed below (pharmacy bulk package) prior to further dilution. stability periods for oxacillin for injection, usp concentration mg/ml sterile water for injection, usp 0.9% sodium chloride injection, usp sodium lactate injection, usp (m/6 sodium lactate) 5% dextrose in water 5% dextrose and 0.45% sodium chloride injection, usp 10% invert sugar injection, usp lactated ringers injection, usp room temperature (25°c) 10-100 4 days 4 days 10-30 24 hrs 24 hrs 0.5-2 6 hrs 6 hrs 6 hrs refrigeration (4°c) 10-100 7 days 7 days 10-30 4 days 4 days 4 days 4 days 4 days frozen (-15°c) 50-100 30 days 250/1.5 ml 30 days 100 30 days 10-100 30 days 30 days 30 days 30 days 30 days stability studies on oxacillin sodium at concentrations of 0.5 mg/ml and 2 mg/ml in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70° f) during a 6-hour period. iv solution 5% dextrose in normal saline 10% d-fructose in water 10% d-fructose in normal saline lactated potassic saline injection 10% invert sugar in normal saline 10% invert sugar plus 0.3% potassium chloride in water travert 10% electrolyte #1 travert 10% electrolyte #2 travert 10% electrolyte #3 only those solutions listed above should be used for the intravenous infusion of oxacillin sodium. the concentration of the antibiotic should fall within the range specified. the drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use. if another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately. pharmacy bulk package this glass pharmacy bulk package bottle contains 10 grams oxacillin sodium and is designed for use in the pharmacy in preparing iv admixtures. add 93 ml sterile water for injection, usp or sodium chloride injection, usp 0.9%. the resulting solution will contain 100 mg oxacillin per ml and will require further dilution. caution: not to be dispensed as a unit . directions for proper use of pharmacy bulk package a) the container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents. b) use of this product is restricted to a suitable work area, such as a laminar flow hood. c) once this container closure has been punctured, withdrawal of the contents should be completed without delay. if prompt fluid transfer cannot be accomplished, discard the contents no later than 4 hours after initial closure puncture. this time limit should begin with the introduction of solvent for diluent into the pharmacy bulk package bottle. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. do not add supplementary medication to oxacillin for injection, usp

on and may include urticaria, pruritus, and fever. although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon. delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy. manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy. nervous system reactions neurotoxic reactions similar to those observed with penicillin g may occur with large intravenous doses of oxacillin, especially in patients with renal insufficiency. urogenital reactions renal tubular damage and interstitial nephritis have been associated infrequently with the administration of oxacillin. manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria, and renal insufficiency. nephropathy induced by penicillins does not appear to be dose-related and is generally reversible upon prompt discontinuation of therapy. gastrointestinal reactions pseudomembranous colitis has been reported with the use of oxacillin. the onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see warnings ). metabolic reactions agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of, oxacillin. hepatotoxicity, characterized by fever, nausea, and vomiting associated with abnormal liver function tests, mainly elevated sgot levels, has been associated with the use of oxacillin. to report suspected adverse reactions, contact piramal critical care at 1-888-822-8431 or fda at 1-800 fda 1088 or www.fda.gov/medwatch.

ministration of probenecid prolongs the elimination of oxacillin and, consequently, increases the serum concentration. intravenous injection gives a peak about 5 minutes after the injection is completed. slow iv dosing with 500 mg gives a 5 minute peak of 43 mcg/ml with a half-life of 20 to 30 minutes. microbiology mode of action penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. all penicillins inhibit the biosynthesis of the bacterial cell wall. mechanism of resistance resistance to penicillins may be mediated by destruction of the beta-lactam ring by a beta-lactamase, altered affinity of penicillin for target, or decreased penetration of the antibiotic to reach the target site. cross resistance resistance to oxacillin (or cefoxitin) implies resistance to all other beta-lactam agents, except newer agents with activity against methicillin-resistant staphylococcus aureus. susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.