Rx only
Fact box
- Therapeutic class
- Macrolides
- Action class
- Macrolide
- Chemical class
- Macrolides
- Habit forming
- No
- Availability
- Prescription (Rx)
Brand names
BenzamycinE.E.S.Emcin ClearEmgelEryEry-TabEryPedErygelErythrocinErythrocin StearateEyemycinMaracynTheramycin
Available as
20 MG/ML40 MG/ML · Topical Solution0.02 MG/MG · Topical Gel500 MG · Injection500 MG · Oral Tablet0.05 MG/MG · Topical Gel0.04 MG/MG · Topical Gel0.005 MG/MG · Ophthalmic Ointment15 MG/ML · Topical Solution250 MG · Oral Capsule250 MG · Oral Tablet25 MG/ML · Oral Suspension333 MG · Oral Tablet20 MG/ML · Topical Solution0.005 MG/MG · Topical Ointment100 MG/ML · Oral Suspension50 MG/ML · Oral Suspension200 MG · Chewable Tablet40 MG/ML · Oral Suspension400 MG · Oral Tablet80 MG/ML · Oral Suspension0.0053 MG/ML · Topical Solution
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
INDICATIONS AND USAGE Erythromycin Topical Solution USP, 2% is indicated for the topical treatment of acne vulgaris.
How it works
CLINICAL PHARMACOLOGY The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. Microbiology – Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.
How to use / dosing
DOSAGE AND ADMINISTRATION Erythromycin Topical Solution USP, 2% should be applied over the affected areas twice a day (morning and evening) after the skin is thoroughly washed with warm water and soap and patted dry. Acne lesions on the face, neck, shoulders, chest, and back may be treated in this manner. This medication should be applied with applicator top. If fingertips are used, wash hands after application. Drying and peeling may be controlled by reducing the frequency of applications.
Side effects
ADVERSE REACTIONS The following local adverse reactions have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with topical use of erythromycin. Generalized urticarial reactions possibly related to the use of erythromycin, which required systemic steroid therapy have been reported.
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyUnsafe
Pregnancy: Teratogenic Effects: Pregnancy Category B - There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation and through weaning of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.
BreastfeedingCaution
Nursing Mothers - It is not known whether erythromycin is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Contraindications
CONTRAINDICATIONS Erythromycin Topical Solution USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Pediatric use
Pediatric Use - Safety and effectiveness of this product in pediatric patients have not been established.
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Current FDA labels (DailyMed)
51 marketed products on record (RxNorm)
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.