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Erythromycin and Benzoyl Peroxide
Overview
What is Erythromycin and Benzoyl Peroxide?
Erythromycin and Benzoyl Peroxide Topical Gel USP contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3--methyl-3--methyl-α-L--hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-dimethylamino)-β-D--hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of (formerly ). It is a base and readily forms salts with acids.
Chemically, erythromycin is (CHNO). It has the following structural formula:
Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25˚C.
Erythromycin and Benzoyl Peroxide Topical Gel USP also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent.
Chemically, benzoyl peroxide is (CHO). It has the following structural formula:
Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether.
Each gram of Erythromycin and Benzoyl Peroxide Topical Gel USP contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, carbomer 940 NF, ethyl alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.
What does Erythromycin and Benzoyl Peroxide look like?
What are the available doses of Erythromycin and Benzoyl Peroxide?
Sorry No records found.
What should I talk to my health care provider before I take Erythromycin and Benzoyl Peroxide?
Sorry No records found
How should I use Erythromycin and Benzoyl Peroxide?
Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
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.
What interacts with Erythromycin and Benzoyl Peroxide?
Erythromycin and Benzoyl Peroxide Topical Gel USP is contraindicated in those individuals who have shown hypersensitivity to any of its components.
What are the warnings of Erythromycin and Benzoyl Peroxide?
Prolonged use of corticosteroids may produce posterior
subcapsular cataracts, glaucoma with possible damage to the optic
nerves, and may enhance the establishment of secondary ocular
infections due to fungi or viruses.
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 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 colitis.
What are the precautions of Erythromycin and Benzoyl Peroxide?
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General:
The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use and take appropriate measures.
Avoid contact with eyes and all mucous membranes.
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- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes, nose, mouth, and all mucous membranes.
- This medication should not be used for any disorder other than that for which it was prescribed.
- Patients should not use any other topical acne preparation unless otherwise directed by physician.
- Patients should report to their physician any signs of local adverse reactions.
- Erythromycin and Benzoyl Peroxide Topical Gel USP may bleach hair or colored fabric.
- Keep product refrigerated and discard after 3 months.
Information for Patients:
Carcinogenesis, Mutagenesis and Impairment of Fertility:
No animal studies have been performed to evaluate the carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.
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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. It also is not known whether Erythromycin and Benzoyl Peroxide Topical Gel USP can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin and Benzoyl Peroxide Topical Gel USP should be given to a pregnant woman only if clearly needed.
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Nursing Women:
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Pediatric Use:
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What are the side effects of Erythromycin and Benzoyl Peroxide?
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 Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Erythromycin and Benzoyl Peroxide?
Erythromycin and Benzoyl Peroxide Topical Gel USP is contraindicated in those individuals who have shown hypersensitivity to any of its components.
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 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 colitis.
What might happen if I take too much Erythromycin and Benzoyl Peroxide?
Sorry No Records found
How should I store and handle Erythromycin and Benzoyl Peroxide?
Sorry No Records found
Clinical Information
Chemical Structure
No Image foundClinical 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.
Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.
Non-Clinical Toxicology
Erythromycin and Benzoyl Peroxide Topical Gel USP is contraindicated in those individuals who have shown hypersensitivity to any of its components.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 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 colitis.
General:
The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use and take appropriate measures.
Avoid contact with eyes and all mucous membranes.
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 Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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