Track topics on Twitter Track topics that are important to you
Topical Gel: erythromycin (3%), benzoyl peroxide (5%) For Dermatological Use Only – Not for Ophthalmic Use Reconstitute Before Dispensing
Erythromycin-Benzoyl Peroxide Topical Gel contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-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). 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-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, Carbomer Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance.
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.
Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S 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.
Benzoyl peroxide is an antibacterial agent which has been shown to be effective against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones. The antibacterial action of benzoyl peroxide is believed to be due to the release of active oxygen.
Erythromycin-Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris.
Erythromycin-Benzoyl Peroxide Topical Gel 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 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.
For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating or abrasive agents. If severe irritation develops, discontinue use and institute appropriate therapy.
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.
Patients using Erythromycin-Benzoyl Peroxide Topical Gel should receive the following information and instructions:
Data from a study using mice known to be highly susceptible to cancer suggests that benzoyl peroxide acts as a tumor promoter. The clinical significance of this is unknown.
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.
Animal reproduction studies have not been conducted with Erythromycin-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel. It also is not known whether Erythromycin-Benzoyl Peroxide Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin-Benzoyl Peroxide Topical Gel should be given to a pregnant woman only if clearly needed.
It is not known whether Erythromycin-Benzoyl Peroxide Topical Gel is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin-Benzoyl Peroxide Topical Gel 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.
Erythromycin-Benzoyl Peroxide Topical Gel 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:
Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin. Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). Erythromycin-Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label.
|NDC 45802-083-||Benzoyl Peroxide Gel||Active Erythromycin Powder (In Plastic Vial)||70% Ethyl Alcohol To Be Added|
NOTE: Prior to reconstitution, store at room temperature between 15° and 30°C (59° – 86°F).
After reconstitution, store under refrigeration between 2° and 8°C (36° – 46°F).
Do not freeze. Keep tightly closed. Keep out of the reach of children.
Manufactured by:Valeant Pharmaceuticals International Inc.Laval, Quebec, Canada H7L 4A8
Distributed by:Perrigo Allegan, MI 49010
Erythromycin-Benzoyl Peroxide Topical Gel
Peroxide Topical Gel
For Topical Use Only
One 23.3 g Jar (as dispensed)
Perrigo New York Inc
BPO 4% Gel
BENZOYL PEROXIDE ALCOHOL BASE GEL, 5%
These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE and BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE and ...
These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL, 1.2% / 5% safely and effectively. See full prescribing information for CLINDAMYCIN PH...
This study aimed to study the efficacy of topical 2.5% benzoyl peroxide, compared to 5% benzoyl peroxide in treatment of unpleasant foot odor, which was considered as major problem related...
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel ...
This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products,...
5 Day study to assess how quickly a topical acne product begins to work.
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and be...
Hair follicles are a promising target for the administration of drugs to treat diseases associated with the pilosebaceous unit, such as acne. For solid lipid microparticle dispersions a successful and...
Bitter taste receptor (TAS2R) agonists have bronchodilatory potentials. Erythromycin is a ligand of TAS2R10, but its relaxant profile is unknown. This study was performed to understand the relaxant ef...
Benzoyl peroxide (BPO) is one of the primary OPs used as an initiator, curing agent, or medicine. Some of the plastic processes use BPO without air for maintaining the efficiency of the entire reactio...
Accurate estimating the level of benzoyl peroxide (BPO) is of considerable significance because of its threat to humanity and environment. Several research efforts have been devoted to the detection o...
Erythromycin is an effective topical antibiotic for treating mild to moderate inflammatory acne vulgaris, especially papules acne during puberty as well as papules - pustular acne in adult women. Eryt...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Acne is a common skin condition that causes spots to develop on the skin, usually on the face, back and chest.. The spots can range from blackheads and whiteheads which are often mild, to inflamed pus-filled pustules and cysts, which can be severe ...