Erythromycin 250 mg/1
Erythromycin · TABLET, FILM COATED · Wilshire Pharmaceuticals
Erythromycin is a prescription antibiotic belonging to the macrolide drug class, used to treat bacterial infections. It is taken by mouth as a 250 mg film-coated tablet.
Key Facts
- Brand Name
- Erythromycin
- Generic Name
- Erythromycin
- NDC Code (Product)
52536-103- Manufacturer
- Wilshire Pharmaceuticals
- Strength
- 250 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA061621
- Drug Class
- Macrolide [EPC]; Macrolide Antimicrobial [EPC]
- Marketing Start
- 03/15/2018
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Teligent Pharma, Inc.
Failed Impurities/Degradation Specifications
Akorn, Inc.
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
McKesson Corporation dba McKesson Drug Company
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Akorn, Inc.
CGMP Deviations:
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Fougera Pharmaceuticals, Inc.
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Teligent Pharma, Inc.
Failed Impurities/Degradation Specifications
Teligent Pharma, Inc.
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Erythromycin Topical Solution USP, 2% is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
DOSAGE AND ADMINISTRATION Erythromycin Topical Solution USP, 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
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
CONTRAINDICATIONS Erythromycin Topical Solution USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Adverse Reactions
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.
Frequently Asked Questions
What is Erythromycin used for?
Erythromycin is a prescription antibiotic belonging to the macrolide drug class, used to treat bacterial infections. It is taken by mouth as a 250 mg film-coated tablet.
Is Erythromycin a controlled substance?
Erythromycin is not classified as a controlled substance by the DEA.
What is the generic name for Erythromycin?
The generic name for Erythromycin is Erythromycin. There are 7 other brand versions of Erythromycin.
What is the NDC code for Erythromycin 250 mg/1?
The NDC (National Drug Code) for Erythromycin 250 mg/1 is 52536-103, listed by Wilshire Pharmaceuticals.