ERYTHROMYCIN TOPICAL SOLUTION USP 2%

FOR TOPICAL USE ONLY.

NOT FOR USE IN EYES.

Rx Only

Erythromycin Topical Solution contains erythromycin for topical dermatologic use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is: (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. It has the following structural formula:

Erythromycin is a white or slightly yellow crystalline powder that is very soluble in water, freely soluble in alcohols, acetone, chloroform, acetonitrile, ethyl acetate, and moderately soluble in ether, ethylene dichloride and amyl acetate.

Each mL of Erythromycin Topical Solution USP 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (71.5%), and propylene glycol. It may contain citric acid to adjust pH.

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.

Erythromycin Topical Solution is indicated for the topical treatment of acne vulgaris.

Erythromycin Topical Solution 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. 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.

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.

Erythromycin Topical Solution 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, shoulder, 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.

Erythromycin Topical Solution USP, 2% is supplied as follows:

60 mL bottle with applicator NDC 0168-0215-60

Store in a dry place at temperatures between 15° - 25°C (59° - 77°F)[See USP Controlled Room Temperature].

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NY 11747

I2215C/IF2215E
R8/06
#85