Label: ERYTHROMYCIN AND BENZOYL PEROXIDE- erythromycin and benzoyl peroxide

  • NDC Code(s): 0781-7054-49, 0781-7094-59, 0781-8054-01, 0781-8094-02, view more
    0781-9054-22, 0781-9094-44
  • Packager: Sandoz Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 26, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx only

     PLEASE READ COMPLETE COMPOUNDING DIRECTIONS
     NOTE: TAP VIAL UNTIL ALL POWDER FLOWS FREELY. ADD ROOM TEMPERATURE  70% ETHYL ALCOHOL TO VIAL (TO THE MARK) AND IMMEDIATELY SHAKE/DISSOLVE COMPLETELY.

    For Dermatological Use Only – Not for Ophthalmic Use

    Reconstitute Before Dispensing

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  • 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 (C37H67NO13). It has the following structural formula:

    318764a6-figure-01

    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 (C14H10O4). It has the following structural formula:

    318764a6-figure-02

    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.

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  • 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 the release of active oxygen.

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  • INDICATIONS AND USAGE

    Erythromycin and benzoyl peroxide topical gel USP, 3%;5% is indicated for the topical treatment of acne vulgaris.

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  • CONTRAINDICATIONS

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

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  • 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.

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  • 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, 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.

    Information for Patients

    Patients using erythromycin and benzoyl peroxide topical gel USP, 3%;5% 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 it 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 USP, 3%;5% 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 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.

    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.

    Nursing Mothers

    It is not known whether erythromycin and benzoyl peroxide topical gel USP, 3%;5% 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.

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  • 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.

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  • 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.

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  • 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° – 46°F).

    Do not freeze. Keep tightly closed. Keep out of the reach of children.

    Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088.

    Manufactured by
    TOLMAR Inc.
    Fort Collins, CO 80526 for
    Sandoz Inc.
    Princeton, NJ  08540

    04275 Rev. 6 04/11

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

     0.8g vial

    0.8g vial

    1.6g vial

    1.6g vial

      23.3g jar

    23.3g jar

     

    46.6g jar

    46.6g jar

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  • INGREDIENTS AND APPEARANCE
    ERYTHROMYCIN AND BENZOYL PEROXIDE 
    erythromycin and benzoyl peroxide kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-7054
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-7054-49 1 in 1 CARTON; Type 0: Not a Combination Product 03/29/2004
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 VIAL, PLASTIC 0.8 g
    Part 2 1 JAR 20 g
    Part 1 of 2
    ERYTHROMYCIN 
    erythromycin gel
    Product Information
    Item Code (Source) NDC:0781-8054
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D) ERYTHROMYCIN 30 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-8054-01 0.8 g in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065112
    Part 2 of 2
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Item Code (Source) NDC:0781-9054
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    WATER (UNII: 059QF0KO0R)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-9054-22 20 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065112
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065112 03/29/2004
    ERYTHROMYCIN AND BENZOYL PEROXIDE 
    erythromycin and benzoyl peroxide kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-7094
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-7094-59 1 in 1 CARTON; Type 0: Not a Combination Product 03/29/2004
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 VIAL, PLASTIC 1.6 g
    Part 2 1 JAR 40 g
    Part 1 of 2
    ERYTHROMYCIN 
    erythromycin gel
    Product Information
    Item Code (Source) NDC:0781-8094
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D) ERYTHROMYCIN 30 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-8094-02 1.6 g in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065112
    Part 2 of 2
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Item Code (Source) NDC:0781-9094
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    WATER (UNII: 059QF0KO0R)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-9094-44 40 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065112
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065112 03/29/2004
    Labeler - Sandoz Inc. (110342024)
    Establishment
    Name Address ID/FEI Business Operations
    TOLMAR Inc. 791156578 ANALYSIS(0781-7054, 0781-7094, 0781-8054, 0781-9054, 0781-8094, 0781-9094) , LABEL(0781-7054, 0781-7094, 0781-8054, 0781-9054, 0781-8094, 0781-9094) , MANUFACTURE(0781-7054, 0781-7094, 0781-8054, 0781-9054, 0781-8094, 0781-9094) , PACK(0781-7054, 0781-7094, 0781-8054, 0781-9054, 0781-8094, 0781-9094)
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