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  • CLASSES

    Topical Antiinfectives for Acne
    Topical Peroxide Agents for Acne

    DEA CLASS

    Rx

    DESCRIPTION

    Topical antibacterial acne product
    Indicated for the treatment of acne vulgaris
    Combination more effective than either agent alone and may decrease the development of bacterial resistance

    COMMON BRAND NAMES

    Benzamycin

    HOW SUPPLIED

    Benzamycin/Benzoyl Peroxide;Erythromycin Topical Pwd: 5-3%
    Benzamycin/Benzoyl Peroxide;Erythromycin/Erythromycin, Benzoyl Peroxide Topical Gel: 3-5%, 5-3%

    DOSAGE & INDICATIONS

    For the treatment of acne vulgaris.
    Topical dosage
    Adults

    Apply topically to the affected area twice daily, morning and evening.

    Children and Adolescents 12 to 17 years

    Apply topically to the affected area twice daily, morning and evening.

    MAXIMUM DOSAGE

    Adults

    No maximum dosage information is available.

    Geriatric

    No maximum dosage information is available.

    Adolescents

    No maximum dosage information is available.

    Children

    12 years: No maximum dosage information is available.
    1 to 11 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Topical Administration

    For external use only.
    Do not use near the eyes, nose, mouth, or other mucous membranes. Do not apply to areas of raw or irritated skin.
    Make sure to wash hands after applying to remove any remaining medication.
    Do not apply other topical products to the same area within 1 hour of applying these products, unless indicated by prescriber.
    Before applying benzoyl peroxide; erythromycin, wash the affected area with a non-medicated cleanser and pat dry. Apply enough medication to cover the area and rub in gently.
     
    Compounding of Benzoyl Peroxide topical gel; Erythromycin bulk powder
    Tap vial containing erythromycin powder until the powder flows freely.
    Add ethanol (70%) to fill to the mark indicated on the vial. Immediately shake to completely dissolve erythromycin.
    Add the dissolved erythromycin solution to the benzoyl peroxide gel and stir until homogenous in appearance (1 to 2 minutes).
    Storage: After reconstitution, store refrigerated (2 to 8 degrees C) for up to 3 months; do not freeze.
     
    Compounding of Benzoyl Peroxide; Erythromycin topical gel
    Mix the contents of the 2 separate compartments of the foil pouch in the palm of the hand.
    Apply immediately after mixing.
    Do not mix or apply near an open flame.

    STORAGE

    Aktipak:
    - Keep away from heat and flame
    - Store between 68 to 77 degrees F
    Benzamycin:
    - Do not freeze
    - Product should be used within 3 months after opening
    - Store reconstituted product in refrigerator (36 to 46 degrees F)
    - Store unreconstituted product at 59 to 86 degrees F
    Benzamycin Pak:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Eczema, skin abrasion, skin disease, sunburn, sunlight (UV) exposure

    Use of a benzoyl peroxide; erythromycin combination product in patients with skin disease such as dermatitis, seborrhea, and eczema or with skin abrasion or inflammation, denuded skin including sunburn or windburn may increase the risk of skin irritation. The benzoyl peroxide; erythromycin should be discontinued until skin sensitivity resolves. Patients should limit their sunlight (UV) exposure while using benzoyl peroxide; erythromycin to decrease the risk for skin irritation.

    Macrolide hypersensitivity

    Benzoyl peroxide; clindamycin products are contraindicated in patients with macrolide hypersensitivity, benzoyl peroxide hypersensitivity, or hypersensitivity to any other components of the product.

    C. difficile-associated diarrhea, diarrhea, pseudomembranous colitis

    Consider pseudomembranous colitis in patients presenting with diarrhea after antibacterial use. Careful medical history is necessary as pseudomembranous colitis has been reported to occur over 2 months after the administration of antibacterial agents. Almost all antibacterial agents, including erythromycin, have been associated with pseudomembranous colitis or C. difficile-associated diarrhea (CDAD) which may range in severity from mild to life-threatening. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

    Myasthenia gravis

    Although systemic absorption may be limited, use benzoyl peroxide; erythromycin with caution in patients with myasthenia gravis. Two case reports suggest that IV erythromycin may aggravate the weakness of patients with myasthenia gravis.

    Accidental exposure, ocular exposure

    Avoid accidental exposure of benzoyl peroxide; erythromycin products to the eyes, lips, mucus membranes and inflamed or raw skin due to severe irritation. If unintended mucus membrane or ocular exposure occurs, thoroughly rinse affected areas with water.

    Pregnancy

    There are no studies of benzoyl peroxide; erythromycin use in human pregnancy and animal studies have not been conducted with benzoyl peroxide; erythromycin or benzoyl peroxide. It is unknown if topical benzoyl peroxide; erythromycin causes fetal harm or can affect reproductive capacity; therefore, use only during pregnancy if clearly indicated.
     

    Breast-feeding

    It is unknown if benzoyl peroxide is excreted in breast milk; however, very little benzoic acid is absorbed systemically with topical use of benzoyl peroxide. Erythromycin is secreted in breast milk after oral and parenteral administration, but the result after topical administration is not known. However, systemic absorption of topically applied erythromycin is minimal. Previous American Academy of Pediatrics recommendations considered erythromycin compatible with breast-feeding. 

    ADVERSE REACTIONS

    Severe

    C. difficile-associated diarrhea / Delayed / Incidence not known

    Moderate

    erythema / Early / 0.8-2.5
    blepharitis / Early / 1.7-1.7
    pseudomembranous colitis / Delayed / Incidence not known
    superinfection / Delayed / Incidence not known

    Mild

    xerosis / Delayed / 5.0-7.6
    urticaria / Rapid / 3.0-3.0
    pruritus / Rapid / 1.7-2.5
    skin irritation / Early / 0.8-2.5
    photosensitivity / Delayed / 1.3-1.3
    ocular irritation / Rapid / Incidence not known
    skin discoloration / Delayed / Incidence not known

    DRUG INTERACTIONS

    Clindamycin; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
    Dapsone: (Minor) Coadministration of topical benzoyl peroxide-containing products with topical sulfone products, such as dapsone, may cause skin and facial hair to temporarily change color to a yellow/orange color.
    Fluocinolone; Hydroquinone; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided. (Minor) Keratolytic agents or products that contain keratolytic agents, such as benzoyl peroxide, can potentiate the skin irritation caused by hydroquinone and hydroquinone-containing products. Also, concurrent use of topical hydroquinone and topical peroxide (e.g., benzoyl peroxide) on the same area of skin can result in transient dark staining of the skin due to oxidation of hydroquinone. Removal of staining can be accomplished by discontinuing concurrent use and by normal soap cleansing. Concurrent application of such agents should generally be avoided.
    Halobetasol; Tazarotene: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
    Hydroquinone: (Minor) Keratolytic agents or products that contain keratolytic agents, such as benzoyl peroxide, can potentiate the skin irritation caused by hydroquinone and hydroquinone-containing products. Also, concurrent use of topical hydroquinone and topical peroxide (e.g., benzoyl peroxide) on the same area of skin can result in transient dark staining of the skin due to oxidation of hydroquinone. Removal of staining can be accomplished by discontinuing concurrent use and by normal soap cleansing. Concurrent application of such agents should generally be avoided.
    Isotretinoin: (Moderate) Benzoyl peroxide will cause additive irritant and drying effects with concomitant oral isotretinoin use. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Mequinol; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided. (Moderate) Mequinol; tretinoin (Solage) solution contains a high concentration of ethanol which may be very drying to the skin. The concomitant use of other medications or skin-care items with drying effects can be additive or cause irritation, including astringents, benzoyl peroxide, salicylic acid, medicated soaps/shampoos, or hair waxes.
    Porfimer: (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
    Salicylic Acid: (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Sodium Thiosulfate; Salicylic Acid: (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Tazarotene: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
    Topical Local Anesthetics: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
    Tretinoin, ATRA: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
    Tretinoin; Benzoyl Peroxide: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
    Trifarotene: (Moderate) Avoid concurrent use of trifarotene with other topical products that may dry or irritate the skin, such as benzoyl peroxide.
    Verteporfin: (Moderate) Use caution if coadministration of verteporfin with benzoyl peroxide is necessary due to the risk of increased photosensitivity. Verteporfin is a light-activated drug used in photodynamic therapy; all patients treated with verteporfin will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no studies of benzoyl peroxide; erythromycin use in human pregnancy and animal studies have not been conducted with benzoyl peroxide; erythromycin or benzoyl peroxide. It is unknown if topical benzoyl peroxide; erythromycin causes fetal harm or can affect reproductive capacity; therefore, use only during pregnancy if clearly indicated.
     

    It is unknown if benzoyl peroxide is excreted in breast milk; however, very little benzoic acid is absorbed systemically with topical use of benzoyl peroxide. Erythromycin is secreted in breast milk after oral and parenteral administration, but the result after topical administration is not known. However, systemic absorption of topically applied erythromycin is minimal. Previous American Academy of Pediatrics recommendations considered erythromycin compatible with breast-feeding. 

    MECHANISM OF ACTION

    Benzoyl peroxide and erythromycin have antimicrobial effects against Propionibacterium acnes, which is the predominant organism in sebaceous follicles and comedones. The antibacterial effects of benzoyl peroxide are due to the release of free-radical oxygen species capable of oxidizing bacterial proteins. Erythromycin binds to the 50-S ribosomal subunit, inhibiting bacterial protein synthesis. Erythromycin is mainly bacteriostatic. The resolution of acne typically occurs within 4—6 weeks of initiating treatment. Resolution coincides with the reduction in levels of P. acnes, lipids, and free fatty acids in the skin follicle. Benzoyl peroxide also exhibits keratolytic action, which produces drying and desquamative actions that contribute to its efficacy in comedone treatment.

    PHARMACOKINETICS

    Benzoyl peroxide; erythromycin is applied topically. In the skin, benzoyl peroxide is metabolized to benzoic acid. Approximately 5% of benzoic acid is systemically absorbed and excreted in the urine. The pharmacokinetics of topical erythromycin have not been described.

    Topical Route

    After topical application to the skin, benzoyl peroxide is absorbed through the epidermis. Approximately 5% of the benzoic acid is systemically absorbed.