section name header

Introduction

VA Class:AM200

AHFS Class:

Generic Name(s):

Erythromycin ethylsuccinate is a macrolide antibiotic.

Dosage and Administration

[Section Outline]

Administration !!navigator!!

Erythromycin ethylsuccinate is administered orally. Erythromycin ethylsuccinate oral suspensions,115,119 chewable tablets,119 and film-coated tablets115 may be administered without regard to meals. Chewable tablets should not be swallowed whole.

The fixed-combination preparation containing erythromycin ethylsuccinate and sulfisoxazole acetyl is administered orally and may be given without regard to meals.120 Because the fixed-combination preparation contains a sulfonamide, the preparation should not be used in infants younger than 2 months of age, pregnant women at term, or mothers who are nursing infants younger than 2 months of age.120

Dosage !!navigator!!

Dosage of erythromycin ethylsuccinate is expressed in terms of erythromycin. Since the ethylsuccinate has different absorption characteristics in adults than do other commercially available forms of erythromycin, higher oral doses are needed to achieve therapeutic effects. The manufacturer states that, for adults, 400 mg of erythromycin as the ethylsuccinate provides erythromycin activity similar to that provided by 250 mg of erythromycin as the base, stearate, or estolate.115,119

The usual adult oral dosage of erythromycin as the ethylsuccinate is 400 mg every 6 hours.115,119 In severe infections, dosage may be increased up to 4 g daily.115,119 The usual oral dosage of erythromycin as the ethylsuccinate in children is 30-50 mg/kg daily in 4 equally divided doses every 6 hours.115,119 For more severe infections, this dosage may be doubled.115,119 An alternative pediatric dosage of 0.9-3 g/m2 daily in 4 equally divided doses has been recommended. The manufacturer states that adults and children may receive one-half the total daily dose of erythromycin ethylsuccinate every 12 hours as an alternative dosage schedule,115 but some clinicians believe this schedule is inadequate for all but minor infections caused by highly susceptible organisms. The manufacturer also states that adults and children may receive one-third the total daily dose every 8 hours as an alternative dosage schedule.115

Pharyngitis and Tonsillitis

If erythromycin ethylsuccinate is used for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci), the usual dosage is 40 mg/kg daily given in 2-4 divided doses for 10 days.102

Prophylaxis of Recurrent Rheumatic Fever

For continuous prophylaxis to prevent recurrences in patients with a history of rheumatic heart disease, the manufacturer recommends oral erythromycin as the ethylsuccinate in a dosage of 400 mg twice daily.115,119

When selecting anti-infectives for prophylaxis of recurrent rheumatic fever, the current recommendations published by the American Heart Association (AHA) should be consulted.104

Prevention of Bacterial Endocarditis

Because of adverse GI effects and the complicated pharmacokinetics of the various erythromycin formulations, current recommendations of the AHA for prevention of bacterial endocarditis no longer include erythromycins as alternatives to penicillins in penicillin-allergic patients.116 However, the AHA states that clinicians who have successfully used an erythromycin for prophylaxis in individual patients may choose to continue using these agents.116 If erythromycin ethylsuccinate is used for prophylaxis of bacterial endocarditis in penicillin-allergic patients at risk who are undergoing certain dental or upper respiratory tract procedures, the AHA recommends that adults receive 800 mg of erythromycin as the ethylsuccinate 2 hours before the procedure and 400 mg 6 hours later and that children receive 20 mg/kg 2 hours before the procedure and 10 mg/kg 6 hours later.111 Pediatric dosage should not exceed adult dosage.111

When selecting anti-infectives for prophylaxis of bacterial endocarditis, the current recommendations published by the AHA should be consulted.116

Syphilis

Although penicillin G is the drug of choice for all stages of syphilis,100,101,102 the manufacturer states that erythromycin as the ethylsuccinate may be given orally in a dosage of 48-64 g over 10-15 days for the treatment of primary syphilis in adults.115 Erythromycin is no longer included in US Centers for Disease Control and Prevention (CDC) recommendations for the treatment of any form of syphilis in adults or adolescents (including primary, secondary, latent, or tertiary or neurosyphilis) and is not recommended for the treatment of congenital syphilis or syphilis in older infants and children.101 In addition, erythromycin is no longer recommended by the CDC or American Academy of Pediatrics (AAP) for the treatment of syphilis in pregnant women who are hypersensitive to penicillin since numerous treatment failures (including in the fetus) have been reported with the drug.101,102

Gonorrhea and Associated Infections

The AAP currently recommends that all children beyond the neonatal period being treated for uncomplicated vulvovaginal, urethral, or pharyngeal gonorrhea, epididymitis, proctitis, or disseminated gonococcal infections, including meningitis or endocarditis, receive presumptive treatment for possible coexisting chlamydial infections.102 If oral erythromycin is used for presumptive treatment of chlamydial infection in children who weigh less than 45 kg, the AAP recommends a dosage of 50 mg/kg daily (maximum 2 g daily) given in 4 divided doses for 7 days.102

Nongonococcal Urethritis

When oral erythromycin ethylsuccinate is used as an alternative to azithromycin or doxycycline for the treatment of nongonococcal urethritis, the CDC and manufacturer recommend a regimen of 800 mg of erythromycin 4 times daily for 7 days.100,101,115,119

Patients with recurrent and persistent urethritis who were not compliant with the full course of erythromycin therapy or who were reexposed to untreated sexual partner(s) should receive a second course of oral erythromycin.101 If the patient has recurrent and persistent urethritis, was compliant with the regimen, and reexposure can be excluded, the CDC recommends that oral erythromycin ethylsuccinate be given in regimen of 800 mg of erythromycin 4 times daily for 7 days in conjunction with a single 2-g dose of oral metronidazole.101

Chlamydial Infections

For the treatment of uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis in nonpregnant adults or adolescents when azithromycin or tetracyclines cannot be used, the CDC and others recommend oral erythromycin as the ethylsuccinate in a dosage 800 mg 4 times daily for 7 days.100,101 The dosage of erythromycin as the ethylsuccinate recommended by the CDC for the treatment of these infections in children weighing 45 kg or less is 50 mg/kg daily given in 4 divided doses for 14 days.101

For the treatment of chlamydial urogenital infections during pregnancy, the recommended dosage of oral erythromycin as the ethylsuccinate is 800 mg 4 times daily for 7 days;100,101 for women who cannot tolerate this regimen, a dosage of oral erythromycin as the ethylsuccinate of 400 mg 4 times daily for 14 days may be used.101

For the treatment of pneumonia caused by C. trachomatis or ophthalmia neonatorum caused by C. trachomatis in infants, the recommended dosage of oral erythromycin is 50 mg/kg daily given in 4 divided doses for 14 days;100,101 follow-up is recommended and a second course of therapy may be necessary.101

For the treatment of trachoma in children, oral erythromycin has been given for 40 days in conjunction with topical anti-infective therapy; however, optimum therapy has not been established, and treatment may be difficult.102

Intestinal Amebiasis

Although erythromycin is not considered a drug of choice for the treatment of intestinal amebiasis caused by Entamoeba histolytica ,102 the manufacturer states that adults may receive 400 mg of erythromycin as the ethylsuccinate orally 4 times daily for 10-14 days, and children may be given 30-50 mg/kg daily in divided doses for 10-14 days.115,119

Pertussis

Although the optimum dosage and duration of erythromycin for the treatment of pertussis or prevention in susceptible contacts have not been established, a dosage of 1 g daily in adults and 40-50 mg/kg daily (maximum 2 g daily) in children given in divided doses for 14 days usually is recommended.102,105,106,107,108,109,110 While a shorter duration of erythromycin therapy (e.g., 7 or 10 days) may be effective in some patients, 102,113 prophylaxis failures and bacteriologic relapse of pertussis have been reported with erythromycin regimens shorter than 14 days.105,106,107,108,109,110,113 Therefore, the CDC,103 US Public Health Service Advisory Committee on Immunization Practices (ACIP),114 AAP,102 and some clinicians105,106,108,109,110 recommend that a 14-day course of erythromycin therapy be used for treatment or prevention of pertussis.

Although data from controlled studies are lacking, the CDC recommends that all household and other close contacts of individuals with pertussis receive a 14-day regimen of prophylaxis (regardless of age and vaccination status) since this may prevent or minimize transmission of the disease.103 In addition, all close contacts younger than 7 years of age who are not fully immunized against pertussis should receive the remaining required doses of a preparation containing pertussis vaccine (using minimal intervals between doses) and those who are fully immunized but have not received a vaccine dose within the last 3 years should receive a booster dose of a pertussis vaccine preparation.103

Legionnaires' Disease

Although the optimum dosage and duration of erythromycin for the treatment of Legionnaires' disease have not been established, dosages of erythromycin as the ethylsuccinate of 1.6-4 g daily in divided doses have been given alone or in combination with rifampin.102,115,117,118 A parenteral regimen usually is necessary for the initial treatment of severe Legionnaires' disease and the addition of rifampin is recommended during the first 3-5 days of therapy in severely ill and/or immunocompromised patients; after a response is obtained, rifampin can be discontinued and therapy changed to oral erythromycin.102,117,118 The duration of therapy in patients with Legionnaires's disease usually is 10-21 days;102,117,118 some clinicians recommend 14 days of therapy for patients with mild disease and 21 days for those who are immunocompromised or have severe disease. 102

Acute Otitis Media

For the treatment of acute otitis media caused by susceptible strains of Haemophilus influenzae in children 2 months of age or older, a commercially available fixed-combination preparation containing erythromycin ethylsuccinate and sulfisoxazole acetyl is used.120 Dosage of the combination preparation may be expressed in terms of erythromycin or sulfisoxazole.120 The usual oral dosage for children 2 months of age or older expressed in terms of erythromycin is 12.5 mg/kg every 6 hours or 17 mg/kg every 8 hours and the usual dosage expressed in terms of sulfisoxazole is 37.5 mg/kg every 6 hours or 50 mg/kg every 8 hours (not to exceed a total daily dose of 6 g).120 Alternatively, the following approximate dosages, expressed in terms of volumes of erythromycin ethylsuccinate and sulfisoxazole acetyl suspension (200 mg of erythromycin per 5 mL), can be used:

6-Hour Dosing

Weight

Dose (repeated every 6 h for 10 days)

<8 kg

Calculate dose by body weight

8-15.9 kg

2.5 mL

16-23.9 kg

5 mL

24-31.9 kg

7.5 mL

>32 kg

10 mL

8-Hour Dosing

Weight

Dose (repeated every 8 h for 10 days)

<6 kg

Calculate dose by body weight

6-11.9 kg

2.5 mL

12-17.9 kg

5 mL

18-23.9 kg

7.5 mL

24-30 kg

10 mL

>30 kg

12.5 mL

When the fixed-combination preparation is used, the precautions and contraindications of sulfonamides must also be considered.120 Erythromycin ethylsuccinate and sulfisoxazole acetyl suspension should not be administered to children younger than 2 months of age.120

Other Information

[Section Outline]

Chemistry and Stability

Chemistry !!navigator!!

Erythromycin ethylsuccinate occurs as a white or slightly yellow, odorless or practically odorless, practically tasteless, crystalline powder. The drug is very slightly soluble in water, freely soluble in alcohol, and soluble in polyethylene glycol.

Stability !!navigator!!

Erythromycin ethylsuccinate chewable tablets119 and film-coated tablets115 should be stored at less than 30°C. The manufacturer of E.E.S.® Liquid recommends that these oral suspensions be stored at 2-8°C until dispensed to preserve taste; once dispensed, these suspensions are stable for 14 days at room temperature.115 Prior to reconstitution, E.E.S® granules for oral suspension should be stored at less than 30°C; after reconstitution, the oral suspension should be refrigerated and used within 10 days.115 The manufacturer of EryPed® for oral suspension states that this preparation should be stored at less than 30°C prior to reconstitution; after reconstitution, this oral suspension should be stored at less than 25°C and is stable for 35 days at room temperature.119 Commercially available suspensions of erythromycin ethylsuccinate have expiration dates of 18 months following the dates of manufacture; commercially available erythromycin ethylsuccinate tablets and powder for oral suspension have expiration dates of 2 years following the dates of manufacture.

The commercially available fixed-combination preparation containing erythromycin ethylsuccinate and sulfisoxazole acetyl should be stored at less than 30°C prior to reconstitution; after reconstitution, the oral suspension should be refrigerated and unused portions discarded after 14 days.120

Additional Information

For further information on chemistry, mechanism of action, spectrum, resistance, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of erythromycin ethylsuccinate, see the Erythromycins General Statement 8:12.12.04.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Erythromycin Ethylsuccinate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

100 mg (of erythromycin) per 2.5 mL

EryPed® Drops

Abbott

200 mg (of erythromycin) per 5 mL

E.E.S.® Granules

Abbott

EryPed®

Abbott

400 mg (of erythromycin) per 5 mL

EryPed®

Abbott

Suspension

200 mg (of erythromycin) per 5 mL*

E.E.S.® Liquid

Abbott

Erythromycin Ethylsuccinate Suspension

400 mg (of erythromycin) per 5 mL*

E.E.S.® Liquid

Abbott

Erythromycin Ethylsuccinate Suspension

Tablets, chewable

200 mg (of erythromycin)

EryPed® (scored)

Abbott

Tablets, film-coated

400 mg (of erythromycin)*

E.E.S.® Filmtab®

Abbott

Erythromycin Ethylsuccinate Film-coated Tablets

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Erythromycin Ethylsuccinate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

200 mg (of erythromycin) per 5 mL with Sulfisoxazole Acetyl 600 mg (of sulfisoxazole) per 5 mL*

Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl Suspension

Eryzole®

Alra

Pediazole®

Ross

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Copyright

AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Anon. Drugs for sexually transmitted infections. Med Lett Treat Guid . 2004; 2:67-74.

101. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep . 2002; 51(No. RR-6):1-78. [Fulltext MMWR]

102. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:164-6,203-6,208-12,230-4,254-62,364-5,435-48,526-36.

103. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 7th ed. Public Health Foundation; 2002 Jan:58-70.

104. Dajani A, Taubert K, Ferrieri P et al and the American Heart Association Committee on Rheumatic Fever et al. Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals. Pediatrics . 1995; 96:758-64. [PubMed 7567345]

105. Bass JW. Erythromycin for pertussis: probable reasons for past failures. Lancet . 1985; 2:147. [PubMed 2862331]

106. Bass JW. Erythromycin for treatment and prevention of pertussis. Pediatr Infect Dis . 1986; 5:154-7. [PubMed 2868449]

107. Bergquist SO, Bernander S, Doahnsjo H et al. Erythromycin in the treatment of pertussis: a study of bacteriologic and clinical effects. Pediatr Infect Dis J . 1987; 6:458-61. [PubMed 2885802]

108. Steketee RW, Wassilak SGF, Adkins WN et al. Evidence for a high attack rate and efficacy of erythromycin prophylaxis in a pertussis outbreak in a facility for the developmentally disabled. J Infect Dis . 1988; 157:434-40. [PubMed 3257783]

109. Halsey NA, Welling MA, Lehman RM. Nosocomial pertussis: a failure of erythromycin treatment and prophylaxis. Am J Dis Child . 1980; 134:421-2.

110. Bass JW. Use of erythromycin in pertussis outbreaks. Pediatrics . 1983; 72:748-9. [PubMed 6356008]

111. Dajani AS, Bisno AL, Chung KJ et al. Prevention of bacterial endocarditis: recommendations by the American Heart Association. JAMA . 1990; 264:2919-22. [PubMed 2146414]

112. Petersen EA. Prevention of bacterial endocarditis. Arch Intern Med . 1990; 150:2447-8. [PubMed 2244761]

113. Halperin SA, Bortolussi R, Langley JM et al. Seven days of erythromycin estolate is as effective as fourteen days for the treatment of Bordetella pertussis infections. Pediatrics . 1997; 100:65-71. [PubMed 9200361]

114. Centers for Disease Control Immunization Practices Advisory Committee (ACIP). Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures. MMWR Morb Mortal Wkly Rep . 1991; 40:1-28. [PubMed 1898620]

115. Abbott Laboratories. E.E.S.® (erythromycin ethylsuccinate) prescribing information (dated 2000 Feb). In: Physicians' desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:450-2.

116. Dajani AS, Taubert KA, Wilson W et al. Prevention of bacterial endocarditis: recommendations by the American Heart Association. JAMA . 1997; 277:1794-801. [PubMed 9178793]

117. Stout JE, Yu VL. Legionellosis. N Engl J Med . 1997; 337:682-7. [PubMed 9278466]

118. Edelstein PH. Legionnaires' disease. Clin Infect Dis . 1993; 16:741-9. [PubMed 8329504]

119. Abbott Laboratories. EryPed® (erythromycin ethylsuccinate) prescribing information (dated 2000 Apr). In: Physicians' desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:446-8.

120. Ross. Pediazole® (erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension) prescribing information (dated 1994 Jul). In: Physicians' desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:3050-1.