Erythromycin And Benzoyl Peroxide

Description

DESCRIPTION Benzamycin ® 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 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. Benzamycin Topical Gel 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 Benzamycin 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. chemstructure.jpg structuralform.jpg

What Is Erythromycin And Benzoyl Peroxide Used For?

INDICATIONS AND USAGE Benzamycin Topical Gel is indicated for the topical treatment of acne vulgaris.

Dosage and Administration

DOSAGE AND ADMINISTRATION Benzamycin 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.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS In controlled clinical trials, the incidence of adverse reactions associated with the use of Benzamycin 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications

CONTRAINDICATIONS Benzamycin Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Pregnancy and Breastfeeding

Pregnancy: Teratogenic Effects: Animal reproduction studies have not been conducted with Benzamycin 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 Benzamycin Topical Gel. It also is not known whether Benzamycin Topical Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Benzamycin Topical Gel should be given to a pregnant woman only if clearly needed.

Nursing Women: It is not known whether Benzamycin 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.

How Supplied

How Supplied and Compounding Directions: Size Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added (Net Weight) NDC 46.6 grams 0187-5205-46 40 grams 1.6 grams 6 mL (as dispensed) 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). Benzamycin Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. NOTE: Prior to reconstitution, store at room temperature between 15° to 30°C (59° to 86°F). After reconstitution, store under refrigeration between 2° to 8°C (36° to 46°F). Do not freeze. Keep tightly closed. Keep out of reach of children.