Erythromycin and Benzoyl Peroxide Topical Gel, USP Topical gel: erythromycin (3%), benzoyl peroxide (5%)

erythromycin and benzoyl peroxide (Erythromycin and Benzoyl Peroxidegel 
[Sandoz Inc.]

Rx only

PLEASE READ COMPLETE COMPOUNDING DIRECTIONS

NOTE: TAP UNTIL ALL POWDER FLOWS FREELY, ADD ETHYL ALCOHOL (70%) TO VIAL (TO THE MARK) AND IMMEDIATELY SHAKE/DISSOLVE COMPLETELY.

For Dermatological Use Only – Not for Ophthalmic Use

Reconstitute Before Dispensing

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-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexa-methyl-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 (C37H67NO13). It has the structural formula:

Image from Drug Label Content

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 also contains bezoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent.

Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula:

Image from Drug Label Content

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 erthromycin and 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, ethyl alcohol, carbomer, sodium hydroxide, docusate sodium and fragrance.

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 desquarmative 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: Erthromycin 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.

INDICATIONS AND USAGE

Erythromycin and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS

Erythromycin and benzoyl peroxide topical gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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 difficle 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.

PRECAUTIONS

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, desquarmating 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 non-susceptible organisms including fungi. If this occurs, discontinue use and take appropriate measures.

Avoid contact with eyes and all mucous membranes.

Information for Patients

Patients using erythromycin and benzoyl peroxide topical gel should receive the following information and instructions.

  1. 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.

  2. This medication should not be used for any disorder other than that for which is was prescribed.

  3. Patients should not use any other topical acne preparation unless otherwise directed by physician.

  4. Patients should report to their physician any signs of local adverse reactions.

  5. Erythromycin and benzoyl peroxide topical gel may bleach hair or colored fabric.

  6. Keep product refrigerated and discard after 3 months.

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 of 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.

Pregnancy

Teratogenic Effects

Pregnancy CATEGORY C: Animal reproduction studies have not been conducted with erythromycin and 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 and benzoyl peroxide topical gel. It also is not known whether erythromycin and benzoyl peroxide topical gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin and benzoyl peroxide topical gel should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether erythromycin and 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.

Pediatric Use

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

ADVERSE REACTIONS

In controlled clinical trials, the total incidence of adverse reactions associated with the use of erythromycin and 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.

DOSAGE AND ADMINISTRATION

Erythromycin and 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

Compounding Directions
Size
(Net Weight)
NDC 0781-Benzoyl Peroxide GelActive Erythromycin Powder
(In Plastic Vial)
Ethyl  Alcohol (70%)
To Be Added
23.3 grams(as dispensed)7054-4920 grams0.8 grams3 mL
46.6 grams(as dispensed)7054-5940 grams1.6 grams6 mL

TO THE PHARMACIST: IMPORTANT – Prior to dispensing, tap vial until powder flows freely. Add indicated amount of ethyl alcohol (70%) to vial (to the mark) and immediately shake to completely dissolve erythromycin. Add this solution to gel and stir with supplied spatula until homogenous in appearance (1 to 1 ½ minutes). Erythromycin and benzoyl peroxide 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 20° to 25°C (68° – 77°F). [See USP Controlled Room Temperature].

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
QLT USA, Inc.
Distributed by
Sandoz Inc.
Princeton, NJ  08540

04275 Rev. 3 7/06


Erythromycin and Benzoyl Peroxide (Erythromycin and Benzoyl Peroxide)
PRODUCT INFO
Product Code0781-7054Dosage FormGEL
Route Of AdministrationTOPICALDEA Schedule
INGREDIENTS
Name (Active Moiety)TypeStrength
erythromycin (erythromycin) Active30 MILLIGRAM  In 1 GRAM
benzoyl peroxide (benzoyl peroxide) Active50 MILLIGRAM  In 1 GRAM
waterInactive 
ethyl alcoholInactive 
carbomerInactive 
sodium hydroxideInactive 
docusate sodiumInactive 
fragranceInactive 
IMPRINT INFORMATION
CharacteristicAppearanceCharacteristicAppearance
ColorScore
ShapeSymbol
Imprint CodeCoating
Size
PACKAGING
#NDCPackage DescriptionMultilevel Packaging
10781-7054-4923.3 GRAM In 1 JARNone
20781-7054-5946.6 GRAM In 1 JARNone

Revised: 09/2007Sandoz Inc.