oside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. urinary tract infections caused by sensitive strains of e. coli and proteus mirabilis . gastrointestinal infections caused by salmonella typhi (typhoid fever), other salmonella spp., and shigella spp. (dysentery) usually respond to oral or intravenous therapy. bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. therapy may be instituted prior to obtaining results of susceptibility testing. it is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. a change to oral ampicillin may be made as soon as appropriate. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection, usp and other antibacterial drugs, ampicillin for injection, usp 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. indicated surgical procedures should be performed.

s, 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 ampicillin for injection, 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.

therapy. urethritis in males due to n. gonorrhoeae. adults – two doses of 500 mg each at an interval of 8 to 12 hours. treatment may be repeated if necessary or extended if required. in the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. in all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. the doses for the preceding infections may be given by either the intramuscular or intravenous route. a change to oral ampicillin may be made when appropriate. bacterial meningitis adults and children - 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) the doses for other infections may be given by either the intravenous or intramuscular route. neonates (less than or equal to 28 days of postnatal age) - dosage should be based on gestational age and postnatal age according to table 1. table 1: dosage in neonates (less than or equal to 28 days of postnatal age) for bacterial meningitis and septicemia: gestational age (weeks) postnatal age (days) dosage less than or equal to 34 less than or equal to 7 100 mg/kg/day in equally divided doses every 12 hours less than or equal to 34 greater than or equal to 8 and less than 28 150 mg/kg/day in equally divided doses every 12 hours greater than 34 less than or equal to 28 150 mg/kg/day in equally divided doses every 8 hours septicemia adults and children – 150 to 200 mg/kg/day. start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours. neonates (less than or equal to 28 days of postnatal age) - dosage should be based on gestational age and postnatal age according to table 1 (above). treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. a minimum of 10 days treatment is recommended for any infection caused by group a beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis. directions for use use only freshly prepared solutions. intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period. for intramuscular use dissolve contents of a vial with the amount of sterile water for injection, usp, or bacteriostatic water for injection, usp, listed in the table below: ndc 70594 label claim recommended amount of diluent withdrawable volume concentration (in mg/ml) 084-01 250 mg 1 ml 1 ml 250 mg 085-01 500 mg 1.8 ml 2 ml 250 mg 086-01 1 gram 3.5 ml 4 ml 250 mg 087-01 2 grams 6.8 ml 8 ml 250 mg while ampicillin for injection, usp, 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. in such instances, dissolve in 3.5 or 6.8 ml sterile water for injection, usp, or bacteriostatic water for injection, usp, respectively. the resulting solution will provide a concentration of 250 mg per ml. for direct intravenous use add 5 ml sterile water for injection, usp, or bacteriostatic water for injection, usp to the 250, and 500 mg vials and administer slowly over a 3- to 5-minute period. ampicillin for injection, usp, 1 g or 2 g may also be given by direct intravenous administration. dissolve in 7.4 or 14.8 ml sterile water for injection, usp, or bacteriostatic water for injection, usp, respectively, and administer slowly over at least 10 to 15 minutes. caution: more rapid administration may result in convulsive seizures. for administration by intravenous drip reconstitute as directed above ( for direct intravenous use ) prior to diluting with intravenous solution. stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated. room temperature (25° c) diluent concentrations stability periods sterile water for injection up to 30 mg/ml 8 hours 0.9% sodium chloride injection, usp up to 30 mg/ml 8 hours 5% dextrose injection, usp 10 to 20 mg/ml 1 hours 5% dextrose injection, usp up to 2 mg/ml 2 hours 5% dextrose and 0.45% sodium chloride injection, usp up to 2 mg/ml 2 hours lactated ringer's injection, usp up to 30 mg/ml 8 hours refrigerated (4° c) diluent concentrations stability periods sterile water for injection 30 mg/ml 48 hours sterile water for injection up to 20 mg/ml 72 hours 0.9% sodium chloride injection, usp 30 mg/ml 24 hours 0.9% sodium chloride injection, usp up to 20 mg/ml 48 hours lactated ringer's injection, usp up to 30 mg/ml 24 hours 5% dextrose injection, usp up to 20 mg/ml 1 hour 5% dextrose and 0.45% sodium chloride injection, usp up to 10 mg/ml 1 hour only those solutions listed above should be used for the intravenous infusion of ampicillin for injection, usp. the concentrations 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 ampicillin is administered before the drug loses its stability in the solution in use.

istamines and, if necessary, systemic corticosteroids. whenever such reactions occur, ampicillin should be discontinued, unless, in the opinion of the physician, the condition being treated is life- threatening and amenable only to ampicillin therapy. serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids. liver – a moderate rise in serum glutamic oxaloacetic transaminase (sgot) has been noted, particularly in infants, but the significance of this finding is unknown. mild transitory sgot elevations have been observed in individuals receiving larger (two to four times) than usual and oft-repeated intramuscular injections. evidence indicates that glutamic oxaloacetic transaminase (got) is released at the site of intramuscular injection of ampicillin sodium and that the presence of increased amounts of this enzyme in the blood does not necessarily indicate liver involvement. hemic and lymphatic systems – anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with the penicillins. these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. central nervous system - seizures to report suspected adverse reactions, contact xellia pharmaceuticals usa, llc at safety@xellia.com or 1-833-295-6953, or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

most strains of the following organisms, clinical efficacy for infections other than those included in the indications and usage section has not been demonstrated. antibacterial activity the following bacteria have been shown in in vitro studies to be susceptible to ampicillin for injection, usp: gram-positive bacteria hemolytic and nonhemolytic streptococci streptococcus pneumoniae nonpenicillinase-producing staphylococci clostridium spp. b. anthracis listeria monocytogenes most strains of enterococci. gram-negative bacteria h. influenzae n. gonorrhoeae n. meningitidis proteus mirabilis many strains of salmonella, shigella , and e. coli . ampicillin does not resist destruction by penicillinase. 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.

ken the last dose of the antibiotic. if this occurs, patients should contact their physician as soon as possible.