section name header

Introduction

VA Class:AM200

AHFS Class:

Generic Name(s):

Erythromycin stearate is a macrolide antibiotic.

Dosage and Administration

[Section Outline]

Administration !!navigator!!

Erythromycin stearate is administered orally. Optimal absorption occurs when the drug is administered in the fasting state or immediately before a meal.111

Dosage !!navigator!!

Dosage of erythromycin stearate is expressed in terms of erythromycin.

The usual adult dosage of erythromycin as the stearate is 250 mg every 6 hours or 500 mg every 12 hours.111 In severe infections, dosage in adults may be increased to 4 g or more daily.111 A twice-daily dosing schedule is not recommended when dosages greater than 1 g daily are administered;111 some clinicians believe the twice-daily schedule is inadequate for all but minor infections caused by highly susceptible organisms.

The usual erythromycin dosage in children is 30-50 mg/kg daily given in 2-4 equally divided doses.102,111 For more severe infections, this dosage may be doubled but should not exceed 4 g daily.111 An alternative pediatric dosage of 0.9-3 g/m2 daily given in 4 equally divided doses has been recommended. A twice-daily dosing schedule is not recommended when dosages greater than 1 g daily are administered;111 some clinicians believe the twice-daily schedule is inadequate for all but minor infections caused by highly susceptible organisms.

Pharyngitis and Tonsillitis

If erythromycin stearate is used for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci), the drug should be given in the usual dosage for 10 days or longer.104,111

Prophylaxis of Recurrent Rheumatic Fever

For continuous prophylaxis to prevent recurrences in patients with a history of rheumatic heart disease, the usual oral dosage of erythromycin is 250 mg twice daily.102,104,111

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.112 However, the AHA states that practitioners who have successfully used an erythromycin for prophylaxis in individual patients may choose to continue using these agents.112 If erythromycin stearate is used for prophylaxis of bacterial endocarditis in penicillin-allergic patients at risk who are undergoing certain dental or upper respiratory procedures, the AHA recommends that adults receive 1 g of erythromycin as the stearate 2 hours before the procedure and 500 mg 6 hours later and that children receive 20 mg/kg 2 hours before the procedure and 10 mg/kg 6 hours later.113 Pediatric dosage should not exceed adult dosage.113

When selecting anti-infectives for prophylaxis of bacterial endocarditis, the current recommendations published by the AHA should be consulted.112

Syphilis

Although penicillin G is the drug of choice for all stages of syphilis,101,102 the manufacturer states that 30-40 g of oral erythromycin has been given in divided doses over 10-15 days for the treatment of primary syphilis.111 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 syphilis 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 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

Although erythromycin is not included in the current CDC recommendations for the treatment of acute pelvic inflammatory disease (PID) caused by N. gonorrhoeae ,101 the manufacturer recommends a regimen of 500 mg of erythromycin (as the lactobionate) IV every 6 hours for 3 days followed by 500 mg of oral erythromycin every 12 hours or 333 mg every 8 hours for 7 days for the treatment of these infections.111 However, some clinicians believe this oral dosage is inadequate and recommend 500 mg every 6 hours for 7-10 days.

Nongonococcal Urethritis

When erythromycin is used as an alternative to azithromycin or doxycycline for the treatment of nongonococcal urethritis in adults and adolescents, the CDC recommends an oral erythromycin dosage of 500 mg 4 times daily for 7 days.101

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 a regimen of 500 mg of oral erythromycin 4 times daily for 7 days given 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 and adolescents, the CDC recommends oral erythromycin in a dosage of 500 mg 4 times daily for 7 days.101 The dosage of oral erythromycin recommended by 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 is 500 mg 4 times daily for 7 days; for women who cannot tolerate this regimen, a dosage of 250 mg 4 times daily for 14 days may be used.101,102,111

Intestinal Amebiasis

Although erythromycin is not considered a drug of choice for the treatment of intestinal amebiasis caused by Entamoeba histolytica ,102 the manufacturers state that adults may receive 250 mg of erythromycin as the stearate 4 times daily for 10-14 days, and children may receive 30-50 mg/kg daily in divided doses for 10-14 days.111

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.105,106,107,108,109,110,114,117 While a shorter duration of erythromycin therapy (e.g., 7 or 10 days) may be effective in some patients, 102,115 prophylaxis failures and bacteriologic relapse of pertussis have been reported with erythromycin regimens shorter than 14 days.105,106,107,108,109,110,114 Therefore, the CDC,103 US Public Health Service Advisory Committee on Immunization Practices (ACIP),117 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 1-4 g daily in divided doses have been given alone or in conjunction with rifampin.102,115,116 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.102,115,116 The duration of therapy in patients with Legionnaires' disease usually is 10-21 days;102,115,116 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

Other Information

[Section Outline]

Chemistry and Stability

Chemistry !!navigator!!

Erythromycin stearate occurs as white or slightly yellow crystals or powder and has a slight bitter taste. The drug is odorless or may have a slight, earthy odor. Erythromycin stearate is practically insoluble in water and soluble in alcohol.

Stability !!navigator!!

Commercially available erythromycin stearate film-coated tablets should be stored in tight, light-resistant containers at 30°C or lower.111 The tablets have expiration dates of 1.5-5 years following the date of manufacture, depending on the manufacturer and packaging.

Additional Information

For further information on chemistry and stability, mechanism of action, spectrum, resistance, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of erythromycin stearate, 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 Stearate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

250 mg (of erythromycin)*

Erythrocin® Stearate Filmtab®

Abbott

Erythromycin Stearate Tablets

500 mg (of erythromycin)*

Erythrocin® Stearate Filmtab®

Abbott

Erythromycin Stearate Tablets

* 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.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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

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; 2000:164-6,208-12,254-62,364-5,435-48,526-36.

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. Abbott Laboratories. Erythrocin® stearate (erythromycin stearate) tablets prescribing information (dated 2000 Nov). In: Physicians' desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:452-4.

112. 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]

113. 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]

114. 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]

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

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

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