erythromycin

FDA Drug Profile — erythromycin

Drug Details

Generic Name
erythromycin
Brand Names
erythromycin
Application Number
ANDA062447
Sponsor
Asclemed USA, Inc.
NDC Codes
9
Dosage Forms
OINTMENT, SOLUTION, POWDER, CAPSULE, DELAYED RELEASE PELLETS
Routes
OPHTHALMIC, TOPICAL, ORAL
Active Ingredients
ERYTHROMYCIN

Indications and Usage

INDICATIONS AND USAGE Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.

Warnings

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.