Erythromycin Topical Gel USP, 2%

For Dermatologic Use Only – Not for Ophthalmic Use

Rx Only

Erythromycin Topical Gel USP, 2% contains erythromycin (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), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids.

Chemically, erythromycin is C₃₇H₆₇NO₁₃. It has the following structural formula:

Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water.

Each gram of Erythromycin Topical Gel USP, 2% (clear, colorless, gel) contains 20 mg of erythromycin USP in a vehicle consisting of alcohol (92% v/v) and hydroxypropyl cellulose.

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 acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.

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

Erythromycin Topical Gel 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. 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.

In controlled clinical trials, the incidence of burning associated with erythromycin topical gel USP, 2% was approximately 25%. The following additional 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 the topical use of erythromycin. A generalized urticarial reaction, possibly related to the use of erythromycin, which required systemic steroid therapy has been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc., at 1-856-697-1441 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Erythromycin Topical Gel USP, 2% should be applied 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. There are no data directly comparing the safety and efficacy of b.i.d. versus q.d. dosing.

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

30 g sealed metal tube (NDC 52565-033-30)

60 g sealed metal tube (NDC 52565-033-60)

Note - FLAMMABLE. Keep away from heat and flame. Store and dispense in original container. Keep tube tightly closed. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured by:
Teligent Pharma, Inc.
Buena, New Jersey 08310

Rev. 10/2017

NDC 52565-033-60

Erythromycin Topical Gel USP, 2%

For Topical Use Only.
Not For Ophthalmic Use.

Net Wt. 60 g

Rx Only