ci); streptococcus pneumoniae (diplococcus pneumoniae). respiratory tract infections due to mycoplasma pneumoniae. skin and skin structure infections of mild to moderate severity caused by streptococcus pyogenes and staphylococcus aureus (resistant staphylococci may emerge during treatment). diphtheria: as an adjunct to antitoxin infections due to corynebacterium diphtheriae to prevent establishment of carriers and to eradicate the organism in carriers. erythrasma: in the treatment of infections due to corynebacterium minutissimum . acute pelvic inflammatory disease caused by neisseria gonorrhoeae : erythromycin lactobionate for injection followed by erythromycin stearate or erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by n. gonorrhoeae in female patients with a history of sensitivity to penicillin. before treatment of gonorrhea, patients who are suspected of also having syphilis should have a microscopic examination for t. pallidum (by immunofluorescence or darkfield) before receiving erythromycin and monthly serologic tests for a minimum of 4 months thereafter. legionnaires' disease caused by legionella pneumophila. although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. prevention of initial attacks of rheumatic fever penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group a beta-hemolytic streptococcal infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis). 1 erythromycin is indicated for the treatment of penicillin-allergic patients. the therapeutic dose should be administered for ten days. prevention of recurrent attacks of rheumatic fever penicillin or sulfonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. in patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the american heart association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). 1 prevention of bacterial endocarditis although no controlled clinical efficacy trials have been conducted, oral erythromycin has been recommended by the american heart association for prevention of bacterial endocarditis in penicillin- allergic patients with prosthetic cardiac valves, most congenital cardiac malformations, surgically constructed systemic pulmonary shunts, rheumatic or other acquired valvular dysfunction, idiopathic hypertrophic subaortic stenosis (ihss), previous history of bacterial endocarditis and mitral valve prolapse with insufficiency when they undergo dental procedures and surgical procedures of the upper respiratory tract. 2 to reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin and other antibacterial drugs, erythromycin 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.

ents 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. qt prolongation life-threatening episodes of ventricular tachycardia associated with prolonged qt intervals (torsades de pointes) have been reported in some patients after intravenous administration of erythromycin lactobionate. susceptibility to the development of torsades de pointes arrhythmias, a rare but serious cardiac condition, is related to electrolyte imbalance, hepatic dysfunction, myocardial ischemia, left ventricular dysfunction, idiopathic q-t prolongation, and concurrent antiarrhythmic therapy. 3 elderly patients exhibit a greater frequency of decreased hepatic function, cardiac function, and of concomitant disease and other drug therapy, and therefore should be monitored carefully during therapy with erythromycin lactobionate for injection. infantile hypertrophic pyloric stenosis (ihps) there have been reports of ihps occurring in infants following erythromycin therapy. since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or chlamydia), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing ihps. parents or caregivers of infants receiving erythromycin should be informed to contact their physician if vomiting or irritability with feeding occurs. drug interactions serious adverse reactions have been reported in patients taking erythromycin concomitantly with cyp3a4 substrates. these include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by cyp3a4 (e.g. verapamil, amlodipine, diltiazem, vasospasm and ischemia with ergotamine/dihydroergotamine) (see precautions – drug interactions ).

olution of erythromycin lactobionate is prepared to give a concentration of 1 g per liter (1 mg/ml). for intermittent infusion: administer one-fourth the total daily dose of erythromycin lactobionate by intravenous infusion in 20 to 60 minutes at intervals not greater than every six hours. the final diluted solution of erythromycin lactobionate is prepared to give a concentration of 1 to 5 mg/ml. no less than 100 ml of iv diluent should be used. infusion should be sufficiently slow to minimize pain along the vein. for treatment of acute pelvic inflammatory disease caused by n. gonorrhoeae , in female patients hypersensitive to penicillins, administer 500 mg erythromycin lactobionate every six hours for three days, followed by oral administration of 250 mg erythromycin stearate or base every six hours for seven days. for treatment of legionnaires' disease: although optimal doses have not been established, doses utilized in reported clinical data were 1 to 4 grams daily in divided doses. administration of doses of ≥4 g/day may increase the risk for the development of erythromycin-induced hearing loss in elderly patients, particularly those with reduced renal or hepatic function. in the treatment of group a beta-hemolytic streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for ten days. the american heart association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides. 1 in prophylaxis against bacterial endocarditis (see indications and usage ) the oral regimen for penicillin allergic patients is erythromycin 1 gram, 1 hour before the procedure followed by 500 mg six hours later. 2 preparation of solution: 1. prepare the initial solution of erythromycin lactobionate for injection by adding 10 ml of sterile water for injection, usp, to the 500 mg vial. use only sterile water for injection, usp, as other diluents may cause precipitation during reconstitution. do not use diluents containing preservatives or inorganic salts. after reconstitution, each ml contains 50 mg of erythromycin activity. the initial solution is stable at refrigerator temperature for two weeks, or for 24 hours at room temperature. 2. add the initial dilution to one of the following diluents before administration to give a concentration of 1 g of erythromycin activity per liter (1 mg/ml) for continuous infusion or 1 to 5 mg/ml for intermittent infusion: 0.9% sodium chloride injection, usp; lactated ringer's injection, usp, normosol tm -r. 3. the following solutions may also be used providing they are first buffered with 4% sodium bicarbonate by adding 1 ml of 4% sodium bicarbonate per 100 ml of solution: 5% dextrose injection, usp 5% dextrose and lactated ringer's injection 5% dextrose and 0.9% sodium chloride injection, usp 4% sodium bicarbonate must be added to these solutions so that their ph is in the optimum range for erythromycin lactobionate stability. acidic solutions of erythromycin lactobionate are unstable and lose their potency rapidly. a ph of at least 5.5 is desirable for the final diluted solution of erythromycin lactobionate. no drug or chemical agent should be added to an erythromycin lactobionate-iv fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined. stability the final diluted solution of erythromycin lactobionate should be completely administered within 8 hours, since it is not suitable for storage. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

eveloping this effect when erythromycin lactobionate for injection doses of 4 grams/day or higher are given. (see dosage and administration )

action erythromycin acts by inhibition of protein synthesis by binding 50 s ribosomal subunits of susceptible organisms. it does not affect nucleic acid synthesis. resistance resistance to erythromycin in s. aureus may emerge during therapy. many isolates of haemophilus influenza are resistant to erythromycin but are susceptible to erythromycin and sulfonamides when used concomitantly. interactions with other antimicrobials antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin and chloramphenicol. antimicrobial activity aerobic bacteria gram-positive bacteria aerobic corynebacterium diphtheriae corynebacterium minutissimum staphylococcus aureus (methicillin-susceptible strains only) streptococcus pneumoniae streptococcus pyogenes gram-negative bacteria legionella pneumophila neisseria gonorrhoeae other microorganisms mycoplasma pneumonia the following in vitro data are available, but their clinical significance is unknown. at least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (mic) less than or equal to the susceptible breakpoint for erythromycin against isolates of similar genus or organism group. . however, the efficacy of erythromycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials. aerobic bacteria gram-negative bacteria moraxella catarrhalis 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.