erythromycin and benzoyl peroxide

FDA Drug Profile — Benzamycin

Drug Details

Generic Name
erythromycin and benzoyl peroxide
Brand Names
Benzamycin
Application Number
NDA050557
Sponsor
Bausch Health US, LLC
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

INDICATIONS AND USAGE Benzamycin Topical Gel 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.