To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate oral suspension and other antibacterial drugs, erythromycin ethylsuccinate oral suspension 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.Erythromycin ethylsuccinate oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H.
influenzae are not susceptible to the erythromycin concentrations ordinarily achieved).
(See appropriate sulfonamide labeling for prescribing information.)Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.Listeriosis caused by Listeria monocytogenes.Pertussis (whooping cough) caused by Bordetella pertussis.
Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.Respiratory tract infections due to Mycoplasma pneumoniae .Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only).
Extraenteric amebiasis requires treatment with other agents.Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: 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.
Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to the penicillins.
In treatment of primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy.
When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.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.
Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, or cisapride.(See PRECAUTIONS - Drug Interactions .)
There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products.There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis.
Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life threatening.
Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.
Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis".After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.
Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone.In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)