Erythromycin And Benzoyl Peroxide
Generic Name: erythromycin and benzoyl peroxide
Brand Names:
Erythromycin And Benzoyl Peroxide
DESCRIPTION Erythromycin and Benzoyl Peroxide Topical Gel USP contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-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)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus ).
Overview
DESCRIPTION Erythromycin and Benzoyl Peroxide Topical Gel USP contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-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)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus ).
Uses
INDICATIONS AND USAGE Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
Dosage
DOSAGE AND ADMINISTRATION Erythromycin and Benzoyl Peroxide Topical Gel USP should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry. How Supplied and Compounding Directions Size (Net weight) NDC Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 64980-328-01 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 64980-328-02 40 grams 1.6 grams 6 mL Pharmacist Important - Prior to dispensing, tap vial until all powder flows freely.
Side Effects
ADVERSE REACTIONS In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin and Benzoyl Peroxide Topical Gel USP was approximately 3%. These were dryness and urticarial reaction. The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. CONTRAINDICATIONS Erythromycin and Benzoyl Peroxide Topical Gel USP is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Pregnancy
Pregnancy: Teratogenic Effects: Animal reproduction studies have not been conducted with Erythromycin and Benzoyl Peroxide Topical Gel USP or benzoyl peroxide. There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters. There are no well-controlled trials in pregnant women with Erythromycin and Benzoyl Peroxide Topical Gel USP.
Storage
How Supplied and Compounding Directions Size (Net weight) NDC Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 64980-328-01 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 64980-328-02 40 grams 1.6 grams 6 mL Pharmacist Important - Prior to dispensing, tap vial until all powder flows freely.
Frequently Asked Questions
What is Erythromycin And Benzoyl Peroxide used for?▼
INDICATIONS AND USAGE Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
What are the side effects of Erythromycin And Benzoyl Peroxide?▼
ADVERSE REACTIONS In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin and Benzoyl Peroxide Topical Gel USP was approximately 3%. These were dryness and urticarial reaction. The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Erythromycin And Benzoyl Peroxide during pregnancy?▼
Pregnancy: Teratogenic Effects: Animal reproduction studies have not been conducted with Erythromycin and Benzoyl Peroxide Topical Gel USP or benzoyl peroxide. There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters. There are no well-controlled trials in pregnant women with Erythromycin and Benzoyl Peroxide Topical Gel USP.
What are the important warnings for Erythromycin And Benzoyl Peroxide?▼
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. CONTRAINDICATIONS Erythromycin and Benzoyl Peroxide Topical Gel USP is contraindicated in those individuals who have shown hypersensitivity to any of its components.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.