Erythromycin - Erythromycin solution prescribing information
INDICATIONS AND USAGE
Erythromycin topical solution, 2% is indicated for the topical treatment of acne vulgaris.
DOSAGE AND 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.
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.
DESCRIPTION
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.
CLINICAL PHARMACOLOGY
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.
Microbiology
Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol, and clindamycin.
HOW SUPPLIED
Erythromycin topical solution, USP 2% is available as follows:
60 mL bottle with applicator (NDC 42571-384-25)
Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
