Brand names: Akne-Mycin, Erygel, Erythro-Rx, Erythra-Derm
Drug class: Antibacterials
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

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Antibacterial; macrolide antibiotic.^b

Uses for Erythromycin (Topical)

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 (Topical) 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 (Topical)

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}

Drug Interactions

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

Erythromycin (Topical) 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 Spectrum

• 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.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.

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

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

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