EMPL Erythromycin Stearate Tablets

Erythromycin Topical Solution USP, 2% is indicated for the topical treatment of acne vulgaris.

• 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

• Safety and effectiveness of this product
• Pediatric patients have not been established

• Patients using Erythromycin Topical Solution USP, 2% should receive the following information and instructions: 1
• This medication is to be used as directed by the physician
• It is for external use only
• Avoid contact with the eyes, nose, mouth, and all mucous membranes. 2
• This medication should not be used for any disorder other than that for which it was prescribed. 3
• Patients should not use any other topical acne medication unless otherwise directed by their physician. 4
• Patients should report to their physician any signs of local adverse reactions

Erythromycin Topical Solution USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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. …

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.

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. …

Store in a dry place at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.