Ery - Padagis Israel Pharmaceuticals Ltd

For Dermatologic Use Only

Not for Ophthalmic Use

Ery 2% Pads contain erythromycin, USP 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:

The chemical name for 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.

Erythromycin has the molecular weight of 733.94. It is a white or slightly yellow, crystalline powder, slightly soluble in water, soluble in alcohol, in chloroform, and in ether. It is odorless or practically odorless. It has a pH range between 8.0 and 10.5 in a methanol and water solution prepared by diluting 1 volume of a methanol solution, containing 40 mg per mL, with 19 volumes of water.

Each mL of expressible liquid contains 20 mg erythromycin in a base of dehydrated alcohol, propylene glycol and citric acid to adjust pH. Each pledget is filled to contain 0.8 mL of Erythromycin Topical Solution 2%.

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.

Ery 2% Pads are indicated for the topical treatment of acne vulgaris.

Ery 2% Pads 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.

The Ery 2% Pads should be rubbed over the affected area twice a day (morning and evening) after skin is thoroughly washed with warm water and soap and patted dry. Acne lesions on the face, neck, shoulders, chest, and back may be treated in this manner. Additional pledgets may be used, if needed. Each pledget should be used once and discarded. Wash hands after application. Close jar tightly after each use. Drying and peeling may be controlled by reducing the frequency of applications.

Ery 2% Pads are available as follows:

A plastic jar containing 60 pledgets (NDC 45802-962-72)

Each pledget is filled to contain 0.8 mL of Erythromycin Topical Solution 2%.

Keep jar tightly closed.

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

Manufactured by Padagis^®
Yeruham, Israel

www.padagis.com

Rev 10-25

6E572 RC F8

PADAGIS is a registered trademark of Padagis US LLC.

Rx Only

Ery 2% Pads (Erythromycin Pledgets USP, 2%)

For External Use

Avoid Contact with Eyes

60 Pledgets