Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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%.; Principal Display Panel Rx Only Ery 2% Pads (Erythromycin Pledgets USP, 2%) For External Use Avoid Contact with Eyes 60 Pledgets The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label serialization-template.jpg
- HOW SUPPLIED 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%.
- Principal Display Panel Rx Only Ery 2% Pads (Erythromycin Pledgets USP, 2%) For External Use Avoid Contact with Eyes 60 Pledgets The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label serialization-template.jpg
Overview
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 C 37 H 67 NO 13 . It has the following structural formula: The chemical name for erythromycin is (3 R *,4 S *,5 S *,6 R *,7 R *,9 R *,11 R *,12 R *,13 S *,14 R *)-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%. Chemical structure
Indications & Usage
Ery 2% Pads are indicated for the topical treatment of acne vulgaris.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS 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.
Contraindications
Ery 2% Pads are contraindicated in those individuals who have shown hypersensitivity to any of its components.
Adverse Reactions
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.
Storage & Handling
STORAGE Keep jar tightly closed. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
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