Class: Antibacterials
VA Class: DE101
Chemical Name: (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
CAS Number: 114-07-8
Brands: Akne-Mycin, Benzamycin, Erygel, Erythro-Rx, Erythra-Derm
Introduction
Antibacterial; macrolide antibiotic.b
Uses for Erythromycin
Acne Vulgaris
Treatment of acne vulgaris.a b c d e 110 111
Generally effective for the treatment of mild to moderate inflammatory acne.b 110 111 Main action is prevention of new lesions.110
May induce bacterial resistance when used as monotherapy;110 111 resistance associated with decreased clinical efficacy.110
Particularly useful when used in combination with benzoyl peroxide or topical retinoids;110 111 reduction in total lesion count of 50–70% reported when combination therapy used.110
Other Uses
Not indicated for the treatment of superficial skin infections (e.g., wound infections).b
Erythromycin Dosage and Administration
General
Apply to all areas of skin prone to acne.110
Maintenance therapy needed to prevent recurrence.110
Administration
Topical
Apply to the skin as a 2% solution, ointment, or gel or as a gel containing erythromycin 3% admixed with benzoyl peroxide 5%.a c d e
For external use only; do not use near eyes, nose, mouth, or other mucous membranes.a b c d e
Apply a thin film of solution, gel, or ointment to cleansed and dried affected area each morning and/or evening.a c d e
Apply the 2% gel to the skin lightly without rubbing.a
Rub pledget saturated with 2% solution over affected area.b d
Commercial preparation containing erythromycin and benzoyl peroxide is supplied in foil pouch with the 2 drugs in separate compartments.c Mix the contents of the 2 compartments in palm of hand, apply immediately, and then wash hands.c
Dosage
Pediatric Patients
Acne Vulgaris
Topical
Apply a thin film to affected area once or twice daily.b c e
Adults
Acne Vulgaris
Topical
Apply a thin film to affected area once or twice daily.a c d e
Cautions for Erythromycin
Contraindications
Known hypersensitivity to erythromycin or any ingredient in the formulation.a c d e
Warnings/Precautions
Warnings
Superinfection/Clostridium difficile-associated Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi.b c e Discontinue drug and institute appropriate therapy if superinfection occurs.b c e
Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.a d
Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.a d Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.105 106 107 108 a d
Use of Fixed Combination
When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.
Specific Populations
Pregnancy
Category B.a d
Category C (admixed preparation containing benzoyl peroxide).c
Lactation
Not known whether erythromycin is distributed into milk following topical application;a c d distributed into milk following systemic administration.a c d Caution if used in nursing women.a c d
Pediatric Use
Safety and efficacy of single-entity topical gel or solution not established in children.a d
Safety and efficacy of admixed preparation (erythromycin and benzoyl peroxide) not established in children <12 years of age.c
Common Adverse Effects
Local dryness, erythema, tenderness, stinging, burning, pruritus, oiliness, desquamation.a b c d e
Interactions for Erythromycin
Cosmetics
Alcohol-containing cosmetics (e.g., astringents, after-shave lotions): Cumulative irritant or drying effect; use with caution.b
Topical Acne Preparations
Medicated soaps or abrasive, peeling, or desquamating agents: Cumulative irritant or drying effect; use with caution.a b c d
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Clindamycin | In vitro antagonisma d | Concomitant use not recommendedb |
Salicylic acid | Cumulative irritant or drying effecta b c d | Use with cautiona b c d |
Sulfur | Cumulative irritant or drying effecta b c d | Use with cautiona b c d |
Tretinoin | Cumulative irritant or drying effecta b c d | Use with cautiona b c d |
Erythromycin Pharmacokinetics
Absorption
Bioavailability
Does not appear to be absorbed systemically following topical application as 2% solution in vehicle containing 77% alcohol and polyethylene glycol and acetone.b
Not known whether absorbed systemically following topical application as ointment.b
Not detectable in plasma in 15 of 16 patients following topical application of a single dose of admixed preparation (erythromycin 3% and benzoyl peroxide 5%).c
Distribution
Extent
Not known whether topically applied erythromycin is distributed into breast milk; systemically administered erythromycin crosses the placenta, but fetal plasma concentrations generally are low.a d
Stability
Storage
Topical
Gel
15–30°C; keep away from heat and open flames.b
Ointment
<27°C.e
Solution
15–30°C; keep away from heat and open flames.b
Actions and SpectrumActions
Usually bacteriostatic; may be bactericidal in high concentrations or against highly susceptible organisms.b
Inhibits protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits.a d
Erythromycin-resistant P. acnes develop during topical therapy when used as monotherapy.110 Partial cross-resistance occurs between erythromycin and clindamycin and lincomycin.b
Advice to Patients
Importance of not using near eyes, nose, mouth, or other mucous membranes.a c d
Use only for condition prescribed.a c d
Importance of reporting any local adverse reactions to clinician.a c d
If admixed preparation (erythromycin and benzoyl peroxide) is used, instruct patient on proper mixing procedure.c
Importance of keeping gel and solution formulations away from heat or open flames.a b c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, particularly topical acne preparations.a c d
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.b
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Bulk | Powder* |
| Erythro-Rx for Prescription Compounding | X-Gen |
Topical | Gel | 2%* | Erythromycin Gel | |
Erygel | Merz | |||
Ointment | 2% | Akne-Mycin | Healthpoint | |
Solution | 2%* | Erythromycin Solution | ||
Erythra-Derm | Paddock |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Gel | 3% with Benzoyl Peroxide 5%* | Benzamycin | Dermik |
Erythromycin and Benzoyl Peroxide Gel |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Benzamycin 5-3% Gel (DERMIK): 46/$229.99 or 139/$665.97
BenzamycinPak 5-3% Packet (DERMIK): 60/$152.99 or 180/$445.97
Benzoyl Peroxide-Erythromycin 5-3% Gel (PERRIGO PHARMACEUTICALS): 23/$58.99 or 69/$159.97
Benzoyl Peroxide-Erythromycin 5-3% Gel (PERRIGO PHARMACEUTICALS): 46/$100.99 or 93/$189.98
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
100. Fulton JE Jr, Pablo G. Topical antibacterial therapy for acne: study of the family of erythromycins. Arch Dermatol. 1974; 110:83-6. [PubMed 4278511]
101. Fisher AA. Erythromycin “free base”—a nonsensitizing topical antibiotic for infected dermatoses and acne vulgaris. Cutis. 1977 (Jul); 20:17,26,30,35.
102. Fisher AA. The safety of topical antibiotics in the treatment of acne vulgaris. Cutis. 1980 (May); 25:474,476,481.
103. Van Ketel WG. Immediate- and delayed-type allergy to erythromycin. Contact Dermatitis. 1976; 2:363-4. [PubMed 1032135]
104. Fisher AA. Is topical erythromycin base non-allergenic? Contact Dermatitis. 1983; 9:243. Letter.
105. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]
106. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]
107. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. (IDIS 386628) [IDIS 386628] [PubMed 9149180]
108. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]
109. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]
110. James WD. Acne. N Engl J Med. 2005; 352:1463-72. [PubMed 15814882]
111. Strauss JS, Krowchuk DP, Leyden JJ et al. Guidelines of care for acne vulgaris management. J Am Acad Dematol. 2007; 56:651-63.
a. Merz Pharmaceuticals. Erygel (erythromycin) topical gel 2% for dermatologic use prescribing information. 2001 Oct. Greensboro, NC.
b. AHFS Drug Information. McEvoy GK, ed. Erythromycin. American Society of Health-System Pharmacists; 2007:3442-4.
c. Dermik Laboratories. Benzamycin Pak (erythromycin 3%-benzoyl peroxide 5%) topical gel for dermatologic use prescribing information. Bridgewater, NJ; 2006 Dec.
d. Fougera. Erythromycin solution prescribing information. Melville, NT; 2006 Aug.
e. Healthpoint. Akne-mycin (erythromycin 2%) ointment for topical use prescribing information. San Antonio, Texas.
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