Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Erythromycin topical solution, USP 2% is available as follows: 60 mL bottle with applicator (NDC 71656-030-60) Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.; Principal display panel-Label NDC 71656-030-60 Erythromycin Topical Solutino, USP 2% For Topical Use Only Not for Ophthalmic Use Rx only 60 mL Label; Principal display panel-Carton NDC 71656-030-60 Erythromycin Topical Solution, USP 2% For Topical Use Only Not for Ophthalmic Use Rx only 60 mL caron
- HOW SUPPLIED Erythromycin topical solution, USP 2% is available as follows: 60 mL bottle with applicator (NDC 71656-030-60) Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
- Principal display panel-Label NDC 71656-030-60 Erythromycin Topical Solutino, USP 2% For Topical Use Only Not for Ophthalmic Use Rx only 60 mL Label
- Principal display panel-Carton NDC 71656-030-60 Erythromycin Topical Solution, USP 2% For Topical Use Only Not for Ophthalmic Use Rx only 60 mL caron
Overview
Erythromycin topical solution, USP 2% contains 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: (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- 0 -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)-ß-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. It has the following structural formula: Molecular Formula: C 37 H 67 NO 13 Molecular Weight: 733.94 Erythromycin, USP is a white or slightly yellow, crystalline powder that is soluble in water, alcohol, chloroform and in ether. Each mL of erythromycin topical solution, USP 2% contains 20 mg of erythromycin base in a vehicle consisting of alcohol (66%), citric acid, and propylene glycol. formula
Indications & Usage
Erythromycin topical solution, 2% is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
Erythromycin topical solution, 2% should be applied over the affected areas twice a day (morning and evening) after the 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. 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.
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
Erythromycin topical solution, 2% is 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. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800‑FDA‑1088 or www.fda.gov/medwatch.