tract infections caused by streptococcus pneumoniae, staphylococcus aureus, haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, escherichia coli, enterobacter aerogenes, proteus mirabilis or serratia marcescens. acute bacterial otitis media caused by streptococcus pneumoniae, haemophilus influenzae (including beta-lactamase producing strains) or moraxella catarrhalis (including beta-lactamase producing strains). note: in one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection compared to 10 days of oral therapy. in a second study comparable cure rates were observed between single dose ceftriaxone for injection and the comparator. the potentially lower clinical cure rate of ceftriaxone for injection should be balanced against the potential advantages of parenteral therapy (see clinical studies ). skin and skin structure infections caused by staphylococcus aureus, staphylococcus epidermidis, streptococcus pyogenes , viridans group streptococci, escherichia coli, enterobacter cloacae, klebsiella oxytoca, klebsiella pneumoniae, proteus mirabilis, morganella morganii, efficacy for this organism in this organ system was studied in fewer than ten infections. pseudomonas aeruginosa, serratia marcescens, acinetobacter calcoaceticus, bacteroides fragilis or peptostreptococcus species. urinary tract infections (complicated and uncomplicated) caused by escherichia coli, proteus mirabilis, proteus vulgaris, morganella morganii or klebsiella pneumoniae. uncomplicated gonorrhea (cervical/urethral and rectal) caused by neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of neisseria gonorrhoeae. pelvic inflammatory disease caused by neisseria gonorrhoeae. ceftriaxone sodium, like other cephalosporins, has no activity against chlamydia trachomatis. therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. bacterial septicemia caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, haemophilus influenzae or klebsiella pneumoniae. bone and joint infections caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, proteus mirabilis, klebsiella pneumoniae or enterobacter species. intra-abdominal infections caused by escherichia coli, klebsiella pneumoniae, bacteroides fragilis, clostridium species (note: most strains of clostridium difficile are resistant) or peptostreptococcus species. meningitis caused by haemophilus influenzae, neisseria meningitidis or streptococcus pneumoniae . ceftriaxone for injection has also been used successfully in a limited number of cases of meningitis and shunt infection caused by staphylococcus epidermidis and escherichia coli. surgical prophylaxis the preoperative administration of a single 1 gram dose of ceftriaxone for injection may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g. , vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g. , during coronary artery bypass surgery). although ceftriaxone for injection has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. when administered prior to surgical procedures for which it is indicated, a single 1 gram dose of ceftriaxone for injection provides protection from most infections due to susceptible organisms throughout the course of the procedure.

ents containing calcium, such as ringer's solution or hartmann's solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for iv administration because a precipitate can form. precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same iv administration line. ceftriaxone must not be administered simultaneously with calcium-containing iv solutions, including continuous calcium-containing infusions such as parenteral nutrition via a y-site. however, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. in vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium (see clinical pharmacology , contraindications and dosage and administration ). neurological adverse reactions serious neurological adverse reactions have been reported during postmarketing surveillance with ceftriaxone use. these reactions include encephalopathy (disturbance of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and non-convulsive status epilepticus (see adverse reactions ). some cases occurred in patients with severe renal impairment who did not receive appropriate dosage adjustment. however, in other cases, neurological adverse reactions occurred in patients receiving an appropriate dosage adjustment. the neurological adverse reactions were reversible and resolved after discontinuation. if neurological adverse reactions associated with ceftriaxone for injection therapy occur, discontinue ceftriaxone for injection and institute appropriate supportive measures. make appropriate dosage adjustments in patients with severe renal impairment (see dosage and administration ). clostridium difficile - associated diarrhea clostridium difficile associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including ceftriaxone, 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. 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. hemolytic anemia an immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including ceftriaxone. severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. if a patient develops anemia while on ceftriaxone, the diagnosis of a cephalosporin associated anemia should be considered and ceftriaxone stopped until the etiology is determined.

nteraction between ceftriaxone for injection and oral calcium-containing products or interaction between intramuscular ceftriaxone for injection and calcium-containing products (iv or oral). neonates hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone for injection. ceftriaxone for injection is contraindicated in premature neonates (see contraindications ). ceftriaxone for injection is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing iv solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see contraindications ). intravenous doses should be given over 60 minutes in neonates to reduce the risk of bilirubin encephalopathy. pediatric patients for the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). the total daily dose should not exceed 2 grams. for the treatment of acute bacterial otitis media, a single intramuscular dose of 50 mg/kg (not to exceed 1 gram) is recommended (see indications and usage ). for the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. the total daily dose should not exceed 2 grams. in the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. the daily dose may be administered once a day (or in equally divided doses every 12 hours). the usual duration of therapy is 7 to 14 days. adults the usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. the total daily dose should not exceed 4 grams. if chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone sodium has no activity against this organism. for the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended. for preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended. generally, ceftriaxone for injection therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. the usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required. when treating infections caused by streptococcus pyogenes , therapy should be continued for at least 10 days. no dosage adjustment is necessary for patients with impairment of renal or hepatic function (see precautions ). the dosages recommended for adults require no modification in elderly patients, up to 2 grams per day, provided there is no severe renal and hepatic impairment (see precautions ). directions for use intramuscular administration reconstitute ceftriaxone for injection powder with the appropriate diluent (see compatibility and stability ). inject diluent into vial, shake vial thoroughly to form solution. withdraw entire contents of vial into syringe to equal total labeled dose. after reconstitution, each 1 ml of solution contains approximately 250 mg or 350 mg equivalent of ceftriaxone for injection according to the amount of diluent indicated below. if required, more dilute solutions could be utilized. a 350 mg/ml concentration is not recommended for the 250 mg vial since it may not be possible to withdraw the entire contents. as with all intramuscular preparations, ceftriaxone for injection should be injected well within the body of a relatively large muscle; aspiration helps to avoid unintentional injection into a blood vessel. vial dosage size amount of diluent to be added 250 mg/ml 350 mg/ml 250 mg 0.9 ml — 500 mg 1.8 ml 1 ml 1 gram 3.6 ml 2.1 ml 2 gram 7.2 ml 4.2 ml intravenous administration ceftriaxone for injection should be administered intravenously by infusion over a period of 30 minutes, except in neonates where administration over 60 minutes is recommended to reduce the risk of bilirubin encephalopathy. concentrations between 10 mg/ml and 40 mg/ml are recommended; however, lower concentrations may be used if desired. reconstitute vials with an appropriate iv diluent (see compatibility and stability ). vial dosage size amount of diluent to be added 250 mg 2.4 ml 500 mg 4.8 ml 1 gram 9.6 ml 2 gram 19.2 ml after reconstitution, each 1 ml of solution contains approximately 100 mg equivalent of ceftriaxone for injection. withdraw entire contents and dilute to the desired concentration with the appropriate iv diluent. compatibility and stability do not use diluents containing calcium, such as ringer's solution or hartmann's solution, to reconstitute ceftriaxone for injection or to further dilute a reconstituted vial for iv administration. particulate formation can result. ceftriaxone for injection has been shown to be compatible with flagyl ® iv (metronidazole hydrochloride). the concentration should not exceed 5 to 7.5 mg/ml metronidazole hydrochloride with ceftriaxone for injection 10 mg/ml as an admixture. the admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (d5w). no compatibility studies have been conducted with the flagyl ® iv rtu ® (metronidazole) formulation or using other diluents. metronidazole at concentrations greater than 8 mg/ml will precipitate. do not refrigerate the admixture as precipitation will occur. vancomycin, amsacrine, aminoglycosides, and fluconazole are incompatible with ceftriaxone for injection in admixtures. when any of these drugs are to be administered concomitantly with ceftriaxone for injection by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations. ceftriaxone for injection solutions should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, due to possible incompatibility (see warnings ). ceftriaxone for injection sterile powder should be stored at 20° to 25°c (68° to 77°f) [see usp controlled room temperature] and protected from light. after reconstitution, protection from normal light is not necessary. the color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. ceftriaxone for injection intramuscular solutions remain stable (loss of potency less than 10%) for the following time periods: storage diluent concentration mg/ml room temp. (25°c) refrigerated (4°c) sterile water for injection 100 250, 350 2 days 24 hours 10 days 3 days 0.9% sodium chloride solution 100 250, 350 2 days 24 hours 10 days 3 days 5% dextrose solution 100 250, 350 2 days 24 hours 10 days 3 days bacteriostatic water + 0.9% benzyl alcohol 100 250, 350 24 hours 24 hours 10 days 3 days 1% lidocaine solution (without epinephrine) 100 250, 350 24 hours 24 hours 10 days 3 days ceftriaxone for injection intravenous solutions, at concentrations of 10, 20 and 40 mg/ml, remain stable (loss of potency less than 10%) for the following time periods stored in glass or pvc containers: storage diluent room temp. (25°c) refrigerated (4°c) sterile water for injection 2 days 10 days 0.9% sodium chloride solution 2 days 10 days 5% dextrose solution 2 days 10 days 10% dextrose solution 2 days 10 days 5% dextrose + 0.9% sodium chloride solution data available for 10 to 40 mg/ml concentrations in this diluent in pvc containers only. 2 days incompatible 5% dextrose + 0.45% sodium chloride solution 2 days incompatible the following intravenous ceftriaxone for injection solutions are stable at room temperature (25°c) for 24 hours, at concentrations between 10 mg/ml and 40 mg/ml: sodium lactate (pvc container), 10% invert sugar (glass container), 5% sodium bicarbonate (glass container), freamine iii (glass container), normosol-m in 5% dextrose (glass and pvc containers), ionosol-b in 5% dextrose (glass container), 5% mannitol (glass container), 10% mannitol (glass container). after the indicated stability time periods, unused portions of solutions should be discarded. note: parenteral drug products should be inspected visually for particulate matter before administration. ceftriaxone for injection reconstituted with 5% dextrose or 0.9% sodium chloride solution at concentrations between 10 mg/ml and 40 mg/ml, and then stored in frozen state (-20°c) in pvc or polyolefin containers, remains stable for 26 weeks. frozen solutions of ceftriaxone for injection should be thawed at room temperature before use. after thawing, unused portions should be discarded. do not refreeze.

gulopathy (0.4%). gastrointestinal diarrhea/loose stools (2.7%). less frequently reported (<1%) were nausea or vomiting, and dysgeusia. the onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see warnings ). hepatic elevations of aspartate aminotransferase (ast) (3.1%) or alanine aminotransferase (alt) (3.3%). less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin. renal elevations of the bun (1.2%). less frequently reported (<1%) were elevations of creatinine and the presence of casts in the urine. central nervous system headache or dizziness were reported occasionally (<1%). genitourinary moniliasis or vaginitis were reported occasionally (<1%). miscellaneous diaphoresis and flushing were reported occasionally (<1%). investigations blood creatinine increased (0.6%). other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness. postmarketing experience in addition to the adverse reactions reported during clinical trials, the following adverse experiences have been reported during clinical practice in patients treated with ceftriaxone. data are generally insufficient to allow an estimate of incidence or to establish causation. a small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone and calcium-containing fluids. in some of these cases, the same intravenous infusion line was used for both ceftriaxone and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. at least one fatality has been reported in a neonate in whom ceftriaxone and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. there have been no similar reports in patients other than neonates. gastrointestinal pancreatitis, stomatitis and glossitis. genitourinary oliguria, ureteric obstruction, post-renal acute renal failure. dermatologic exanthema, allergic dermatitis, urticaria, edema; acute generalized exanthematous pustulosis (agep) and isolated cases of severe cutaneous adverse reactions (erythema multiforme, stevens-johnson syndrome or lyell's syndrome/toxic epidermal necrolysis) have been reported. hematological changes isolated cases of agranulocytosis (< 500/mm 3 ) have been reported, most of them after 10 days of treatment and following total doses of 20 grams or more. neurologic encephalopathy, seizures, myoclonus, and non-convulsive status epilepticus (see warnings and precautions ). other, adverse reactions symptomatic precipitation of ceftriaxone calcium salt in the gallbladder, kernicterus, oliguria, and anaphylactic or anaphylactoid reactions. cephalosporin class adverse reactions in addition to the adverse reactions listed above which have been observed in patients treated with ceftriaxone, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics: adverse reactions allergic reactions, drug fever, serum sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and superinfection. altered laboratory tests positive direct coombs' test, false-positive test for urinary glucose, and elevated ldh (see precautions ). several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see dosage and administration ). if seizures associated with drug therapy occur, the drug should be discontinued. anticonvulsant therapy can be given if clinically indicated. to report suspected adverse reactions, contact xellia pharmaceuticals usa, llc at 1-833-295-6953 or fda at 1-800‑fda‑1088 or www.fda.gov/medwatch .

grams at 12- to 24-hour intervals resulted in 15% to 36% accumulation of ceftriaxone above single dose values. ceftriaxone concentrations in urine are shown in table 2. table 2 urinary concentrations of ceftriaxone after single dose administration average urinary concentrations (mcg/ml) dose/route 0 to 2 hr 2 to 4 hr 4 to 8 hr 8 to 12 hr 12 to 24 hr 24 to 48 hr nd = not determined. 0.5 gram iv 526 366 142 87 70 15 0.5 gram im 115 425 308 127 96 28 1 gram iv 995 855 293 147 132 32 1 gram im 504 628 418 237 nd nd 2 gram iv 2692 1976 757 274 198 40 thirty-three percent to 67% of a ceftriaxone dose was excreted in the urine as unchanged drug and the remainder was secreted in the bile and ultimately found in the feces as microbiologically inactive compounds. after a 1 gram iv dose, average concentrations of ceftriaxone, determined from 1 to 3 hours after dosing, were 581 mcg/ml in the gallbladder bile, 788 mcg/ml in the common duct bile, 898 mcg/ml in the cystic duct bile, 78.2 mcg/gram in the gallbladder wall and 62.1 mcg/ml in the concurrent plasma. over a 0.15 to 3 gram dose range in healthy adult subjects, the values of elimination half-life ranged from 5.8 to 8.7 hours; apparent volume of distribution from 5.78 to 13.5 l; plasma clearance from 0.58 to 1.45 l/hour; and renal clearance from 0.32 to 0.73 l/hour. ceftriaxone is reversibly bound to human plasma proteins, and the binding decreased from a value of 95% bound at plasma concentrations of <25 mcg/ml to a value of 85% bound at 300 mcg/ml. ceftriaxone crosses the blood placenta barrier. the average values of maximum plasma concentration, elimination half-life, plasma clearance and volume of distribution after a 50 mg/kg iv dose and after a 75 mg/kg iv dose in pediatric patients suffering from bacterial meningitis are shown in table 3. ceftriaxone penetrated the inflamed meninges of infants and pediatric patients; csf concentrations after a 50 mg/kg iv dose and after a 75 mg/kg iv dose are also shown in table 3. table 3 average pharmacokinetic parameters of ceftriaxone in pediatric patients with meningitis 50 mg/kg iv 75 mg/kg iv maximum plasma concentrations (mcg/ml) 216 275 elimination half-life (hr) 4.6 4.3 plasma clearance (ml/hr/kg) 49 60 volume of distribution (ml/kg) 338 373 csf concentration-inflamed meninges (mcg/ml) 5.6 6.4 range (mcg/ml) 1.3 to 18.5 1.3 to 44 time after dose (hr) 3.7 (±1.6) 3.3 (±1.4) compared to that in healthy adult subjects, the pharmacokinetics of ceftriaxone were only minimally altered in elderly subjects and in patients with renal impairment or hepatic dysfunction (table 4); therefore, dosage adjustments are not necessary for these patients with ceftriaxone dosages up to 2 grams per day. ceftriaxone was not removed to any significant extent from the plasma by hemodialysis; in six of 26 dialysis patients, the elimination rate of ceftriaxone was markedly reduced. table 4 average pharmacokinetic parameters of ceftriaxone in humans subject group elimination half-life (hr) plasma clearance (l/hr) volume of distribution (l) healthy subjects 5.8 to 8.7 0.58 to 1.45 5.8 to 13.5 elderly subjects (mean age, 70.5 yr) 8.9 0.83 10.7 patients with renal impairment hemodialysis patients (0 to 5 ml/min) creatinine clearance. 14.7 0.65 13.7 severe (5 to 15 ml/min) 15.7 0.56 12.5 moderate (16 to 30 ml/min) 11.4 0.72 11.8 mild (31 to 60 ml/min) 12.4 0.70 13.3 patients with liver disease 8.8 1.1 13.6 the elimination of ceftriaxone is not altered when ceftriaxone is co-administered with probenecid. pharmacokinetics in the middle ear fluid in one study, total ceftriaxone concentrations (bound and unbound) were measured in middle ear fluid obtained during the insertion of tympanostomy tubes in 42 pediatric patients with otitis media. sampling times were from 1 to 50 hours after a single intramuscular injection of 50 mg/kg of ceftriaxone. mean (±sd) ceftriaxone levels in the middle ear reached a peak of 35 (±12) mcg/ml at 24 hours, and remained at 19 (±7) mcg/ml at 48 hours. based on middle ear fluid ceftriaxone concentrations in the 23 to 25 hour and the 46 to 50 hour sampling time intervals, a half-life of 25 hours was calculated. ceftriaxone is highly bound to plasma proteins. the extent of binding to proteins in the middle ear fluid is unknown. interaction with calcium two in vitro studies, one using adult plasma and the other neonatal plasma from umbilical cord blood have been carried out to assess interaction of ceftriaxone and calcium. ceftriaxone concentrations up to 1 mm (in excess of concentrations achieved in vivo following administration of 2 grams ceftriaxone infused over 30 minutes) were used in combination with calcium concentrations up to 12 mm (48 mg/dl). recovery of ceftriaxone from plasma was reduced with calcium concentrations of 6 mm (24 mg/dl) or higher in adult plasma or 4 mm (16 mg/dl) or higher in neonatal plasma. this may be reflective of ceftriaxone-calcium precipitation. microbiology mechanism of action ceftriaxone is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. ceftriaxone has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. mechanism of resistance resistance to ceftriaxone is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (pbps), and decreased permeability. interaction with other antimicrobials in an in vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. ceftriaxone has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the indications and usage section: gram-negative bacteria acinetobacter calcoaceticus enterobacter aerogenes enterobacter cloacae escherichia coli haemophilus influenzae haemophilus parainfluenzae klebsiella oxytoca klebsiella pneumoniae moraxella catarrhalis morganella morganii neisseria gonorrhoeae neisseria meningitidis proteus mirabilis proteus vulgaris pseudomonas aeruginosa serratia marcescens gram-positive bacteria staphylococcus aureus staphylococcus epidermidis streptococcus pneumoniae streptococcus pyogenes viridans group streptococci anaerobic bacteria bacteroides fragilis clostridium species peptostreptococcus species the following in vitro data are available, but their clinical significance is unknown . at least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory concentration (mic) less than or equal to the susceptible breakpoint for ceftriaxone. however, the efficacy of ceftriaxone in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. gram-negative bacteria citrobacter diversus citrobacter freundii providencia species (including providencia rettgeri ) salmonella species (including salmonella typhi ) shigella species gram-positive bacteria streptococcus agalactiae anaerobic bacteria porphyromonas (bacteroides) melaninogenicus prevotella (bacteroides) bivius 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.

abel bacteriologic study of ceftriaxone without a comparator enrolled 108 pediatric patients, 79 of whom had positive baseline cultures for one or more of the common pathogens. the results of this study are tabulated as follows: week 2 and 4 bacteriologic eradication rates in the per protocol analysis in the roche bacteriologic study by pathogen: table 6 bacteriologic eradication rates by pathogen study day 13 to 15 study day 30+2 organism no. analyzed no. erad. (%) no. analyzed no. erad. (%) streptococcus pneumoniae 38 32 (84) 35 25 (71) haemophilus influenzae 33 28 (85) 31 22 (71) moraxella catarrhalis 15 12 (80) 15 9 (60)

. discard unused portion. sterile, nonpyrogenic, preservative-free. the container closure is not made with natural rubber latex.

eness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ceftriaxone or other antibacterial drugs in the future. diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. if this occurs, patients should contact their physician as soon as possible.