Benzyl Peroxide

Benzyl Peroxide is a molecule used for Acne Vulgaris belonging to pharmacology class of Anti-inflammatory agent.

Benzyl Peroxide can be used in the treatment of Acne vulgaris

Benzyl Peroxide approx 5% is absorbed through the skin and get metabolized in the skin to benzoic acid and get excreted Via urine.

The common side effects associated with Benzyl Peroxide include Increased sensitivity to sunlight, skin peeling, redness, swelling, or dryness.

Benzyl Peroxide is available in the form of Gel, creams, foams, lotion.

Benzyl Peroxide is available in Gel, creams, foams, lotion

Topical: All products: Avoid contact with eyes and other mucous membranes. Some products may stain certain fabrics; avoid contact with clothing or furniture. May bleach hair. If bothersome dryness or peeling occurs, reduce dose frequency or drug concentration. If excessive stinging or burning occurs after any single application, remove with mild soap and water; resume use the next day.

Cleansers: Wet skin areas to be treated prior to administration. Gently massage into skin for 10 to 20 seconds, working into a full lather. Rinse thoroughly and pat dry.

Cloths: Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10 to 20 seconds. Rinse thoroughly and pat dry. Throw away cloth; do not flush.

Cream: Prime pump until the first drop of cream is released prior to first use. Apply to each area of the face (cheek, chin, forehead, nose); avoid eyes, lips, and mouth. Avoid contact with cuts, abrasions, and eczematous or sunburned skin. Wash hands after use.

Foam: Prime can prior to initial. Shake vigorously and tap bottom of can onto palm or solid surface 3 times prior to each use. Dispense foam into palm of hand or applicator pad and cover entire affected area and rub in until completely absorbed. Some products can remain on skin and others should be rinsed off after a brief period of time (refer to manufacturers labeling). Rinse applicator with water and allow to dry after use; wash hands with soap and water after use.

Other dose forms: After cleansing skin, smooth small amount over affected area. Shake lotion well prior to use.

Releases free-radical oxygen which oxidizes bacterial proteins in the sebaceous follicles decreasing the number of anaerobic bacteria and decreasing irritating-type free fatty acids.

Benzyl Peroxide is approved for use in the following clinical indications

Acne vulgaris: Treatment of mild to moderate acne vulgaris.

Acne vulgaris:

Note: May be used alone or as part of an appropriate combination regimen. Avoid simultaneous application with topical tretinoin (may reduce tretinoin efficacy). Consider starting with the lowest possible concentration to minimize skin irritation and increase potency as tolerated.

Topical:

Topical formulations: Apply sparingly once daily; gradually increase to 2 to 3 times/day if needed. If excessive dryness or peeling occurs, reduce dose frequency or concentration. If excessive stinging or burning occurs, remove with mild soap and water; resume use the next day.

Topical cleansers: Wash once or twice daily; control amount of drying or peeling by modifying dose frequency or concentration.

Rosacea: Cream: Topical: Apply a pea-sized amount to affected area in a thin layer once daily.

Gel, creams, foams, lotion

• 2.5% ,2.6%,3%, 3.5%,3.6%, 4%,4.25% , 5%,6%,7 %, 8% ,9%, 9.5%, 10%

Gel, creams, foams, lotion

• Dose Adjustment in Pediatric Patient:

Acne vulgaris:

Children ≥7 years and Adolescents: Limited data available in ages <12 years: Topical:

Topical formulations: Apply sparingly once daily; gradually increase to 2 to 3 times daily if needed. If excessive dryness or peeling occurs, reduce dose frequency or concentration. If excessive stinging or burning occurs, remove with mild soap and water; resume use the next day.

Topical cleansers: Wash once or twice daily; control amount of drying or peeling by modifying dose frequency or concentration.

Benzyl Peroxide may be contraindicated in the following conditions:-

The treating physician must closely monitor the patient and keep pharmacovigilance as follows

• Concerns related to adverse effects:

Bleaching effects: May bleach hair, colored fabric, or carpet.

Hypersensitivity reaction: Rare but serious and potentially life-threatening allergic reactions or severe irritation have been reported with use of topical OTC benzoyl peroxide or salicylic acid containing products; it has not been determined if the reactions are due to the active ingredients (benzoyl peroxide or salicylic acid), the inactive ingredients, or a combination of both. Hypersensitivity reactions may occur within minutes to a day or longer after product use and differ from local skin irritation (redness, burning, dryness, itching, peeling or slight swelling) that may occur at the site of product application. Treatment should be discontinued if hives or itching develop; patients should seek emergency medical attention if reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue develop. Before using a topical OTC acne product for the first time, consumers should apply a small amount to 1 or 2 small affected areas for 3 days to make sure hypersensitivity symptoms do not develop.

Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures (eg, hat) are recommended if sun exposure cannot be avoided. Discontinue use at first evidence of sunburn.

Skin irritation: Skin irritation (eg, burning, itching, peeling, redness, swelling) may occur; discontinue use if severe irritation develops.

• Dosage form specific issues:

Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. 

• Concurrent drug therapy issues:

Sulfone products: Concomitant use of benzoyl peroxide with sulfone products (eg, dapsone, sulfacetamide) may cause temporary discoloration (yellow/orange) of facial hair and skin. Application of products at separate times during the day or washing off benzoyl peroxide prior to application of other products may avoid skin discoloration.

• Other warnings/precautions:

Appropriate use: For external use only; avoid contact with eye, eyelids, lips, mouth, and mucous membranes. Inform patients to use skin protection (eg, sunscreen) and minimize prolonged exposure to sun or tanning beds.

There is no sufficient scientific evidence traceable regarding use and safety of Benzyl Peroxide in concurrent use with alcohol.

It is not known if benzoyl peroxide is present in breast milk.

Pregnancy Category (FDA): B Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Benzyl Peroxide. There are, however, no adequate and well-controlled studies in pregnant women. An increase of the abortion rate was found in rats at three times the single human therapeutic dose. While animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

The adverse reactions related to Benzyl Peroxide can be categorized as

Common Adverse effects: Increased sensitivity to sunlight, skin peeling, redness, swelling, or dryness.

Less Common Adverse effects: Mild burning sensation, Allergic contact dermatitis.

The clinically relevant drug interactions of Benzyl Peroxide is briefly summarized here

May reduce the efficacy of tretinoin, isotretinoin, and tazarotene.

May result in temporary skin and facial hair discolouration (yellow/orange) when used concomitantly with sulfonamide- or sulfone-containing products.

The common side of Benzyl Peroxide include the following

Increased sensitivity to sunlight, skin peeling, redness, swelling, or dryness.

Symptom: Severe skin irritation.

Management: Symptomatic treatment. Discontinue use and apply cold compress.

Pharmacodynamics:

Benzoyl peroxide is a highly lipophilic oxidising agent that has mild keratolytic effect and antimicrobial activity against Staphylococcus epidermidis and Propionibacterium acnes. Its antibacterial activity is due to the release of free-radical oxygen which oxidises bacterial protein in the sebaceous follicles reducing the number of anaerobic bacteria and irritating-type free fatty acids.

Pharmacokinetics:

Absorption: Approx 5% is absorbed through the skin.

Metabolism: Metabolized in the skin to benzoic acid.

Excretion: Via urine.

1. https://www.uptodate.com/contents/Benzyl Peroxide -drug-information?search=Benzyl Peroxide &source=panel_search_result&selectedTitle=1~148&usage_type=panel&kp_tab=drug_general&display_rank=1#F154338
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf
3. https://www.medicaid.nv.gov/Downloads/provider/Benzyl Peroxide _2015-1215.pdf
4. https://www.mims.com/india/drug/info/Benzyl Peroxide ?type=full&mtype=generic#mechanism-of-action