Erythromycin Topical Gel USP, 2%

Rx only

FOR DERMATOLOGIC USE ONLY   NOT FOR OPHTHALMIC USE

Erythromycin Topical Gel 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--ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β--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 gram of Erythromycin Topical Gel 2% contains: Active Ingredient: erythromycin USP, 2% (20 mg/g). Inactive Ingredients: alcohol USP, 92% and hydroxypropyl cellulose NF.

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 Gel is indicated for the topical treatment of acne vulgaris.

Erythromycin Topical Gel 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 most common adverse reaction reported with Erythromycin Topical Gel was burning.

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.

Apply sparingly as a thin film to affected area(s) once or twice a day after the skin is thoroughly cleansed and patted dry. If there has been no improvement after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued, and the physician should be reconsulted. Spread the medication lightly rather than rubbing it In. The hands should be washed after application. There are no data directly comparing the safety and efficacy of b.i.d. versus q.d. dosing.

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

30 gram tubes - NDC 0168-0216-30      60 gram tubes - NDC 0168-0216-60

NOTE: FLAMMABLE. Keep away from heat and flame.

Store and dispense in original container.

Keep tube tightly closed.

Store between 15° and 25°C (59° and 77°F).

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

I2216A
#153
R11/98