ERYTHROMYCIN PLEDGETS, USP

For Dermatologic Use Only
Not for Ophthalmic Use

Rx only

Erythromycin Pledgets, USP contains erythromycin ((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-d-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatologic 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 the molecular weight of 733.94

It is a white powder, is freely soluble in alcohols, acetone, chloroform, acetonitrile, ethyl acetate, and moderately soluble in ether, ethylene dichloride and amyl acetate. Erythromycin pledgets, USP are absorbent pads impregnated with Erythromycin Topical Solution 2%. Each pledget contains 1 mL of Erythromycin Topical Solution 2% and each 1 mL of Erythromycin Topical Solution 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (71.5% v/v) and propylene glycol. May contain anhydrous citric acid and/or alcohol 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 pledgets, USP are indicated for the topical treatment of acne vulgaris.

Erythromycin pledgets, USP are 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 pledgets, USP should be rubbed over the affected area twice a day 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. Additional pledgets may be used, if needed. Each pledget should be used once and discarded.

Each pledget is filled to contain 1 mL of Erythromycin Topical Solution USP 2%. Each mL of Erythromycin Topical Solution USP 2% contains 20 mg of erythromycin.

Each pledget is supplied in an individual foil packet in boxes of 60.

NDC 0168-0215-01.

Store at 20°- 25°C (68°- 77°F)[See USP Controlled Room Temperature].

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

IF221501
R6/06
#46

Remove this portion before dispensing

ERYTHROMYCIN PLEDGETS, USP

• This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes.
• This medication should not be used for any disorder other than that for which it was prescribed.
• Patients should not use any other topical acne medication unless otherwise directed by their physician.
• Patients should report to their physician any signs of local adverse reactions.

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