Erythromycin And Benzoyl Peroxide is a human prescription drug labeled by 'Sandoz Inc.'. National Drug Code (NDC) number for Erythromycin And Benzoyl Peroxide is 0781-7094. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Erythromycin And Benzoyl Peroxide drug includes . The currest status of Erythromycin And Benzoyl Peroxide drug is Active.

Erythromycin and benzoyl peroxide erythromycin and benzoyl peroxide erythromycin erythromycin erythromycin erythromycin benzoyl peroxide benzoyl peroxide benzoyl peroxide benzoyl peroxide alcohol carbomer homopolymer type c sodium hydroxide docusate sodium water limonene, (+)- erythromycin and benzoyl peroxide erythromycin and benzoyl peroxide erythromycin erythromycin erythromycin erythromycin benzoyl peroxide benzoyl peroxide benzoyl peroxide benzoyl peroxide alcohol carbomer homopolymer type c sodium hydroxide docusate sodium water limonene, (+)-

Indications and usage erythromycin and benzoyl peroxide topical gel usp, 3%;5% is indicated for the topical treatment of acne vulgaris.

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.

General 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.

Dosage and administration erythromycin and benzoyl peroxide topical gel usp, 3%;5% 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.

Contraindications erythromycin and benzoyl peroxide topical gel usp, 3%;5% is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Adverse reactions in controlled clinical trials, the incidence of adverse reactions associated with the use of erythromycin and benzoyl peroxide topical gel usp, 3%;5% 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.

Pregnancy teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with erythromycin and benzoyl peroxide topical gel usp, 3%;5% 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, 3%;5%. it also is not known whether erythromycin and benzoyl peroxide topical gel usp, 3%;5% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. erythromycin and benzoyl peroxide topical gel usp, 3%;5% should be given to a pregnant woman only if clearly needed.

Pediatric use safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

Description erythromycin and benzoyl peroxide topical gel usp, 3%;5% 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)-ß-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 (c 37 h 67 no 13 ). 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, 3%;5% also contains benzoyl peroxide for topical use. benzoyl peroxide is an antibacterial and keratolytic agent. chemically, benzoyl peroxide is (c 14 h 10 o 4 ). 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, 3%;5% contains, as dispensed, 30 mg (3%) of erythromycin, usp and 50 mg (5%) of benzoyl peroxide, usp in a gel of purified water, usp, alcohol 20%, carbomer homopolymer type c, nf, sodium hydroxide, nf, docusate sodium and fragrance. 318764a6-figure-01 318764a6-figure-02

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. 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. microbiology: 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 t Read more...

Carcinogenesis, mutagenesis, impairment of fertility 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.

How supplied[/s] compounding directions [/tc] size(net weight) ndc 0781- benzoyl peroxide gel active erythromycin powder (in plastic vial) 70% ethyl alcohol to be added 23.3 grams(as dispensed) 7054-49 20 grams 0.8 grams 3 ml 46.6 grams(as dispensed) 7094-59 40 grams 1.6 grams 6 ml to the pharmacist: important – 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 with supplied spatula until homogeneous in appearance (1 to 1 ½ minutes). erythromycin and benzoyl peroxide topical gel usp, 3%;5% should then be stored under refrigeration. do not freeze. place a 3-month expiration date on the label. note: prior to reconstitution, store at 20° to 25°c (68° – 77°f). [see usp controlled room temperature]. after reconstitution, store under refrigeration between 2° and 8°c (36° â€� Read more...

Information for patients patients using erythromycin and benzoyl peroxide topical gel usp, 3%;5% should receive the following information and instructions. 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, 3%;5% may bleach hair or colored fabric. keep product refrigerated and discard after 3 months.

Package label.principal display panel 0.8g vial 1.6g vial 23.3g jar 46.6g jar 0.8g vial 1.6g vial 23.3g jar 46.6g jar