ERYPED SUMMARY
ERY-PED®
(erythromycin ethylsuccinate, USP)
Erythromycin is produced by a strain of
Saccharopolyspora erythraea
(formerly
Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration.
To reduce the development drug-resistant bacteria and maintain the effectiveness of Ery-Ped and other antibacterial drugs, Ery-Ped 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.
Ery-Ped 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, or
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 penicillin-allergic patients. In 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.
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
Streptococcus pyogenes
infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 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).3
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