Acne-10

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Acne-10

Classes

Topical Peroxide Agents for Acne

Administration
Topical Administration

For topical use only. Not for oral, ophthalmic, or intravaginal use.
Avoid contact with the eyes, lips, and mouth.
Do not apply to areas of raw or irritated skin.
Wash hands after use as product may bleach hair or colored fabrics.
Instruct patients not to apply other topical products to the same area during or immediately following use of benzoyl peroxide, unless indicated by the prescriber.

Cream/Ointment/Lotion Formulations

Epsolay 5% cream:
Before initial use, prime the pump until the first drop of cream is release.
Clean and dry affected area before each application.
Apply a pea-sized amount in a thin film to each area of the face (forehead, chin, nose, each check).
Cream or lotion for acne:
Clean the affected area thoroughly before applying.
Apply enough medication to cover the area and rub in gently.

Other Topical Formulations

BenzePro Foam:
Prime container prior to first use by shaking the can vigorously. Hold the can upright over a sink. Direct initial spray to a non-skin surface. Press down on the actuator.
Shake can vigorously before each use.
Hold the can upright, dispense the foam into the palm of the hand and apply to the affected area.
Wipe off any excess fam from the actuator after use.
Wash hands with soap and water.
BenzEFoam foam:
Prime container prior to first use by shaking the can well. Firmly strike bottom of the can onto the palm of the other hand 3 times. Hold the can upright and press down on the actuator for 1 to 3 seconds until foam begins to dispense. Direct initial spray to a non-skin surface; DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant.
Shake can well before each use.
Hold the can upright, dispense foam into palm of the hand or onto an applicator pad.
Rinse applicator with water and allow it to dry after use.
Wash hands with soap and water.
Cleansing bar:
Using warm water, wash affected area for 1 to 2 minutes.
Rinse thoroughly and pat dry with a clean towel.
Emulsion:
Clean the skin thoroughly before applying.
Cover the entire affected area with a thin layer and rinse thoroughly.
Foaming Cloths:
Wet face and cloth with water.
Work cloth into a full lather.
Cleanse face with the cloth for 10 to 20 seconds while avoiding the eyes.
Rinse thoroughly and then pat dry.
Throw away cloth; do not flush.
Gel:
Clean the skin thoroughly before applying.
Cover the entire affected area with a thin layer and rinse thoroughly.
Wash lotion:
Wet skin and liberally apply to areas to be cleansed.
Massage gently into skin for 10 to 20 seconds, working into a full lather.
Rinse thoroughly and pat dry.
If excess drying occurs, control by rinsing off cleanser sooner or using less often.

Adverse Reactions
Severe

anaphylactoid reactions / Rapid / 0-1.0

Moderate

edema / Delayed / Incidence not known

Common Brand Names

Acne Medication, Acne-10, Acneclear, Benprox, Benzac, Benzac AC, Benzac W, Benzac-10, Benzac-5, Benzagel, Benzagel-10, Benzagel-5, BenzaShave, BenzEFoam, BenzEFoam Ultra, BenzePrO, Benziq, BP Cleanser, BP Cleansing Lotion, BP Foaming Wash, BP Gel, BP Topical, BP Wash, BPO, BPO Creamy Wash, BPO Foaming Cloth, Brevoxyl-4, Brevoxyl-8, Clean&Clear Persa-Gel, Clearasil, Clearasil Ultra, Clearasil Vanishing, Clearplex, Clearplex X, Clearskin, Del Aqua, Desquam-E, Desquam-X, EFFACLAR, Enzoclear, EPSOLAY, NeoBenz Micro, NeoBenz Micro SD, Neutrogena Acne Cream, Oscion, Pacnex, PanOxyl, PanOxyl AQ, PanOxyl Aqua, PanOxyl-10, PanOxyl-5, Riax, SE BPO, Seba, Seba-Gel, Soluclenz Rx, Theroxide, TL BPO MX, Triaz, True Marker Lintera

Dea Class

OTC, Rx

Description

Topical oxidizing agent with bactericidal, keratolytic, and sebostatic effects
Approved as a 5% topical cream (Epsolay) for acne rosacea; available in multiple topical formulations for acne vulgaris; has been used off-label for decubitus ulcers
Improves both inflammatory and non-inflammatory acne lesions

Dosage And Indications
For the treatment and prevention of mild or moderate acne vulgaris. Topical dosage (cream, foam, gel, lotion, or solution) Adults

Apply a thin layer topically to the affected skin area(s) 1 to 3 times daily. To minimize potential dryness, start with 1 application daily and gradually increase to 2 to 3 times daily. Reduce application to once daily or every other day if bothersome dryness or peeling occurs.

Adolescents

Apply a thin layer topically to the affected skin area(s) 1 to 3 times daily. To minimize potential dryness, start with 1 application daily and gradually increase to 2 to 3 times daily. Reduce application to once daily or every other day if bothersome dryness or peeling occurs.

Topical dosage (cleansing bar, cleansing lotion, foaming cloth, or liquid) Adults

Apply a liberal amount topically to the affected area(s) of wet skin and massage into a lather 1 to 3 times daily, then rinse thoroughly. To minimize potential dryness, start with 1 application daily and gradually increase to 2 to 3 times daily.

Adolescents

Apply a liberal amount topically to the affected area(s) of wet skin and massage into a lather 1 to 3 times daily, then rinse thoroughly. To minimize potential dryness, start with 1 application daily and gradually increase to 2 to 3 times daily.

For the treatment of inflammatory lesions of acne rosacea. Topical dosage (Epsolay 5% cream only) Adults

Apply a pea-size amount of cream once daily in a thin layer to each area of the face (forehead, chin, nose, each cheek).

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.

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.
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.

How Supplied

Acne Medication/Acne-10/Benzoyl Peroxide/BP Cleansing Lotion/Brevoxyl-4/Theroxide Topical Lotion: 4%, 5%, 10%
Acne Medication/Acneclear/Benzac/Benzac AC/Benzac W/Benzac-10/Benzac-5/Benzagel/Benzagel-10/Benzagel-5/Benzoyl Peroxide/BP Gel/BP Topical/BPO/Brevoxyl-4/Brevoxyl-8/Clean&Clear Persa-Gel/Clearplex/Clearplex X/Desquam-E/Desquam-X/Oscion/PanOxyl/PanOxyl AQ/PanOxyl Aqua/PanOxyl-10/PanOxyl-5/Seba/Seba-Gel/Soluclenz Rx/Triaz Topical Gel: 2.5%, 3%, 4%, 5%, 5.5%, 6%, 8%, 9%, 10%
Benprox/Benzac AC/Benzac W/BenzePrO/Benziq/Benzoyl Peroxide/BP Cleanser/BP Foaming Wash/BP Wash/Desquam-X/NeoBenz Micro/Pacnex/SE BPO/TL BPO MX Topical Susp: 2.5%, 4.25%, 5%, 5.25%, 6.8%, 6.9%, 7%, 10%, 4-5%, 5-8%
BenzEFoam/BenzEFoam Ultra/BenzePrO/Benzoyl Peroxide/Enzoclear/Riax Topical Foam: 5.2%, 5.3%, 5.5%, 9.5%, 9.7%, 9.8%
BenzePrO/Benzoyl Peroxide/BPO Foaming Cloth/Triaz Topical Swab: 5.8%, 6%
Benzoyl Peroxide/BPO Creamy Wash/Brevoxyl-4 Topical Soap: 4-5%, 5-8%
Benzoyl Peroxide/BPO Creamy Wash/Brevoxyl-4/Clearasil/Clearasil Ultra/Clearasil Vanishing/Clearskin/Del Aqua/EFFACLAR/EPSOLAY/NeoBenz Micro/NeoBenz Micro SD/Neutrogena Acne Cream/PanOxyl Topical Cream: 2.5%, 3.5%, 4%, 5%, 5.5%, 8.5%, 10%, 4-5%

Maximum Dosage
Adults

No maximum dosage information is available.

Geriatric

No maximum dosage information is available.

Adolescents

No maximum dosage information is available.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Benzoyl peroxide exhibits 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, which are capable of oxidizing bacterial proteins. Resolution of acne usually occurs within 4 to 6 weeks of initiation of treatment. Resolution coincides with a reduction in levels of P. acnes, lipids, and free fatty acids in the skin follicle. Benzoyl peroxide also demonstrates keratolytic activity, which produces drying and desquamative actions that contribute to its efficacy in comedone treatment. The exact mechanism of action in the treatment of acne rosacea is unknown. In the treatment of decubitus ulcers, benzoyl peroxide stimulates epithelial cell proliferation and the production of granulation tissue.

Pharmacokinetics

Benzoyl peroxide is applied topically. In the skin, benzoyl peroxide is metabolized to benzoic acid, an endogenous substance. It is then eliminated in the urine as benzoate.
 
Affected cytochrome P450 isoenzymes: none

Topical Route

Systemic exposure of benzoyl peroxide following topical application unknown. Drug that is absorbed by the skin is metabolized to benzoic acid, an endogenous substance.

Pregnancy And Lactation
Pregnancy

Available data regarding the use of benzoyl peroxide during pregnancy are insufficient to establish a drug-associated risk of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted. Systemic exposure is unknown, and benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance) which is eliminated in the urine; therefore, maternal use is not expected to result in fetal drug exposure.

There are no data on the presence of benzoyl peroxide in human milk, the effects on a breast-fed infant, or the effects on milk production. Systemic exposure is unknown and benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance) which is eliminated in the urine; therefore, any amount of benzoyl peroxide excreted into human milk by a nursing mother would be rapidly metabolized by tissue and stomach esterases. To minimize potential exposure to a breast-fed infant, use benzoyl peroxide on the smallest area of skin and for the shortest duration possible while breast-feeding. Instruct patients not to apply to the area near the nipples, and be careful to avoid direct contact between the infant and the treated area. Only water-miscible cream products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.