ERYTHROMYCIN TOPICAL SOLUTION, USP 2%

FOR TOPICAL USE ONLY

NOT FOR USE IN EYES

Rx only

Erythromycin Topical Solution, 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 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 C₃₇H₆₇NO₁₃. It has the following structural formula:

Erythromycin has the molecular weight of 733.94. It is a white or slightly yellow, crystalline powder and it is slightly soluble in water; soluble in alcohol, in chloroform and in ether.

Each mL of Erythromycin Topical Solution, USP 2% contains 20 milligrams of erythromycin in a base of alcohol, USP (66.0%) and propylene glycol, USP.

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

Erythromycin Topical Solution, 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.

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 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, USP 2% should be applied to the affected area 2 times a day (morning and evening) after the skin is thoroughly washed with warm water and soap and patted dry. Moisten the applicator or a pad with erythromycin, then rub over the affected area. 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 60432-671-60

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

KEEP TIGHTLY CLOSED

Rx Only

Product No.: 8671

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8671-60

REV. 08-14

MGP

NDC 60432-671-60

ERYTHROMYCIN

TOPICAL

SOLUTION,

USP 2%

FOR TOPICAL USE ONLY

NOT FOR USE IN EYES

SAFETY SEALED BOTTLE

Rx Only

NET: 2 fl oz (60 mL)