Erythromycin Base
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Questions & Answers
Side Effects & Adverse Reactions
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.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ERYTHROMYCIN Base Film-coated tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients 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.
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.)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Base Film-coated tablets and other antibacterial drugs, Erythromycin Base Film-coated tablets 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 Base Film-coated tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms 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 pyogenes or Streptococcus pneumoniae
Listeriosis caused by Listeria monocytogenes.
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).
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.
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: Erythrocin® Lactobionate-I. V. (erythromycin lactobionate for injection, USP ) followed by 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. 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.
Erythromycins are indicated for 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.3
When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.3
Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy.
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.
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).3 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days.
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
History
There is currently no drug history available for this drug.
Other Information
Erythromycin Base Film-coated (erythromycin tablets, USP) is an antibacterial product containing erythromycin, USP, in a unique, nonenteric film coating for oral administration. Erythromycin Base Film-coated tablets are available in two strengths containing either 250 mg or 500 mg of erythromycin base.
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. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O -methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy - 3 - ( dimethylamino)- β - D - xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is:
Colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C Red No. 30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, hydroxypropyl methylcellulose phthalate, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, propylene glycol, sodium citrate, sodium hydroxide, sorbic acid, sorbitan monooleate, talc, and titanium dioxide.
Sources
Erythromycin Base Manufacturers
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Pd-rx Pharmaceuticals, Inc.
![Erythromycin Base (Erythromycin) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Erythromycin Base | Pd-rx Pharmaceuticals, Inc.
Optimal blood levels are obtained when Erythromycin Base Film-coated tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).
AdultsThe usual dosage of Erythromycin Base Film-coated is one 250 mg tablet four times daily in equally spaced doses or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
ChildrenAge, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.
In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least 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.3
Conjunctivitis of the Newborn Caused by Chlamydia trachomatisOral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.3
Pneumonia of Infancy Caused by Chlamydia trachomatisAlthough the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.
Urogenital Infections During Pregnancy Due to Chlamydia trachomatisAlthough the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours or 250 mg by mouth four times a day should be used for at least 14 days.5
For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated: 500 mg of erythromycin by mouth four times a day for at least 7 days.5
For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated: 500 mg of erythromycin by mouth four times a day for at least seven days.5
Primary syphilis30 to 40 g given in divided doses over a period of 10 to 15 days.
Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae500 mg Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours for 7 days.
Intestinal Amebiasis Adults500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days.
Children30 to 50 mg/kg/day in divided doses for 10 to 14 days.
PertussisAlthough optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
Legionnaires' DiseaseAlthough optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.
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Lake Erie Medical Dba Quality Care Products Llc
Erythromycin Base | Lake Erie Medical Dba Quality Care Products Llc
Optimal blood levels are obtained when Erythromycin Base Film-coated tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).
AdultsThe usual dosage of Erythromycin Base Film-coated is one 250 mg tablet four times daily in equally spaced doses or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
ChildrenAge, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.
In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least 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.3
Conjunctivitis of the Newborn Caused by Chlamydia trachomatisOral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.3
Pneumonia of Infancy Caused by Chlamydia trachomatisAlthough the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.
Urogenital Infections During Pregnancy Due to Chlamydia trachomatisAlthough the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours or 250 mg by mouth four times a day should be used for at least 14 days.5
For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated: 500 mg of erythromycin by mouth four times a day for at least 7 days.5
For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated: 500 mg of erythromycin by mouth four times a day for at least seven days.5
Primary syphilis30 to 40 g given in divided doses over a period of 10 to 15 days.
Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae500 mg Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours for 7 days.
Intestinal Amebiasis Adults500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days.
Children30 to 50 mg/kg/day in divided doses for 10 to 14 days.
PertussisAlthough optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
Legionnaires' DiseaseAlthough optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.
-
A-s Medication Solutions Llc
Erythromycin Base | A-s Medication Solutions Llc
In most patients, Erythromycin Base Film-coated tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when Erythromycin Base Film-coated tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).
AdultsThe usual dosage of Erythromycin Base Film-coated is one 250 mg tablet four times daily in equally spaced doses or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
ChildrenAge, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.
In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least 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.3
Conjunctivitis of the Newborn Caused by Chlamydia trachomatisOral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.3
Pneumonia of Infancy Caused by Chlamydia trachomatisAlthough the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.
Urogenital Infections During Pregnancy Due to Chlamydia trachomatisAlthough the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours or 250 mg by mouth four times a day should be used for at least 14 days.5
For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated500 mg of erythromycin by mouth four times a day for at least 7 days.5
For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated500 mg of erythromycin by mouth four times a day for at least seven days.5
Primary syphilis30 to 40 g given in divided doses over a period of 10 to 15 days.
Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae500 mg Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours for 7 days.
Intestinal Amebiasis Adults500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days.
Children30 to 50 mg/kg/day in divided doses for 10 to 14 days.
PertussisAlthough optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
Legionnaires' DiseaseAlthough optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.
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Carilion Materials Management
Erythromycin Base | Carilion Materials Management
In most patients, Erythromycin Tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when Erythromycin Tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).
AdultsThe usual dosage of Erythromycin Tablets is one 250 mg tablet four times daily in equally spaced doses or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
ChildrenAge, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.
In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least 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. 4
Conjunctivitis of the Newborn Caused by Chlamydia trachomatisOral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks. 4
Pneumonia of Infancy Caused by Chlamydia trachomatisAlthough the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.
Urogenital Infections During Pregnancy Due to Chlamydia trachomatisAlthough the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours or 250 mg by mouth four times a day should be used for at least 14 days. 6
For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated500 mg of erythromycin by mouth four times a day for at least 7 days. 6
For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated500 mg of erythromycin by mouth four times a day for at least seven days. 6
Primary syphilis30 to 40 g given in divided doses over a period of 10 to 15 days.
Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae500 mg Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours for 7 days. ®
Intestinal Amebiasis Adults500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days.
Children30 to 50 mg/kg/day in divided doses for 10 to 14 days.
PertussisAlthough optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
Legionnaires' DiseaseAlthough optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.
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