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

Medically reviewed by Drugs.com on Feb 20, 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}

Related/similar drugs

doxycycline, clindamycin topical, erythromycin topical, tetracycline, Tazorac

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. (See Cautions.)

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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