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Erythromycin (Topical)

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, Erygel, Erythro-Rx, Erythra-Derm

Medically reviewed by Drugs.com on February 19, 2021. Written by ASHP.

Introduction

Antibacterial; macrolide antibiotic.

Uses for Erythromycin (Topical)

Acne Vulgaris

Treatment of acne vulgaris.

Generally effective for the treatment of mild to moderate inflammatory acne. Main action is prevention of new lesions.

May induce bacterial resistance when used as monotherapy; resistance associated with decreased clinical efficacy.

Particularly useful when used in combination with benzoyl peroxide or topical retinoids; reduction in total lesion count of 50–70% reported when combination therapy used.

Other Uses

Not indicated for the treatment of superficial skin infections (e.g., wound infections).

Erythromycin (Topical) Dosage and Administration

General

  • Apply to all areas of skin prone to acne.

  • Maintenance therapy needed to prevent recurrence.

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%.

For external use only; do not use near eyes, nose, mouth, or other mucous membranes.

Apply a thin film of solution, gel, or ointment to cleansed and dried affected area each morning and/or evening.

Apply the 2% gel to the skin lightly without rubbing.

Rub pledget saturated with 2% solution over affected area.

Commercial preparation containing erythromycin and benzoyl peroxide is supplied in foil pouch with the 2 drugs in separate compartments. Mix the contents of the 2 compartments in palm of hand, apply immediately, and then wash hands.

Dosage

Pediatric Patients

Acne Vulgaris
Topical

Apply a thin film to affected area once or twice daily.

Adults

Acne Vulgaris
Topical

Apply a thin film to affected area once or twice daily.

Cautions for Erythromycin (Topical)

Contraindications

  • Known hypersensitivity to erythromycin or any ingredient in the formulation.

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Discontinue drug and institute appropriate therapy if superinfection occurs.

Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone. 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.

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.

Category C (admixed preparation containing benzoyl peroxide).

Lactation

Not known whether erythromycin is distributed into milk following topical application; distributed into milk following systemic administration. Caution if used in nursing women.

Pediatric Use

Safety and efficacy of single-entity topical gel or solution not established in children.

Safety and efficacy of admixed preparation (erythromycin and benzoyl peroxide) not established in children <12 years of age.

Common Adverse Effects

Local dryness, erythema, tenderness, stinging, burning, pruritus, oiliness, desquamation.

Interactions for Erythromycin (Topical)

Cosmetics

Alcohol-containing cosmetics (e.g., astringents, after-shave lotions): Cumulative irritant or drying effect; use with caution.

Topical Acne Preparations

Medicated soaps or abrasive, peeling, or desquamating agents: Cumulative irritant or drying effect; use with caution.

Specific Drugs

Drug

Interaction

Comments

Clindamycin

In vitro antagonism

Concomitant use not recommended

Salicylic acid

Cumulative irritant or drying effect

Use with caution

Sulfur

Cumulative irritant or drying effect

Use with caution

Tretinoin

Cumulative irritant or drying effect

Use with caution

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.

Not known whether absorbed systemically following topical application as ointment.

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%).

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.

Stability

Storage

Topical

Gel

15–30°C; keep away from heat and open flames.

Ointment

<27°C.

Solution

15–30°C; keep away from heat and open flames.

Actions and Spectrum

  • Usually bacteriostatic; may be bactericidal in high concentrations or against highly susceptible organisms.

  • Inhibits protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits.

  • Erythromycin-resistant P. acnes develop during topical therapy when used as monotherapy. Partial cross-resistance occurs between erythromycin and clindamycin and lincomycin.

Advice to Patients

  • Importance of not using near eyes, nose, mouth, or other mucous membranes.

  • Use only for condition prescribed.

  • Importance of reporting any local adverse reactions to clinician.

  • If admixed preparation (erythromycin and benzoyl peroxide) is used, instruct patient on proper mixing procedure.

  • Importance of keeping gel and solution formulations away from heat or open flames.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, particularly topical acne preparations.

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.

  • 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

Erythromycin

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

Erythromycin Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Gel

3% with Benzoyl Peroxide 5%*

Benzamycin

Dermik

Erythromycin and Benzoyl Peroxide Gel

AHFS DI Essentials™. © Copyright 2021, Selected Revisions March 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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