Dosing & Uses
Dosing Forms & Strengths
benzoyl peroxide/hydrocortisone
topical lotion
- 5%/0.5%
Acne Vulgaris
Apply a thin film to the affected area qDay-TID; massage gently into skin
Dosage Forms & Strengths
benzoyl peroxide/hydrocortisone
topical lotion
- 5%/0.5%
Acne Vulgaris
<12 years: Safety and effectiveness not established
≥12 years: Apply a thin film to the affected area qDay-TID; massage gently into skin
Adverse Effects
Frequency Not Defined
Benzoyl Peroxide
- Irriation
- Contact dermatitis
- Dryness
- Erythema
- Stinging
- Peeling
Hydrocortisone
- Acneform eruptions
- Allergic contact dermatitis
- Skin atrophy
- Burning
- Dryness
- Folliculitis
- Hypertrichosis
- Hypopigmentation
- Itching
- Irritation
- Miliaria
- Perioral dermatitis
- Secondary infection
- Striae
Warnings
Contraindications
Hypersensitivity to benzoyl peroxide, hydrocortisone or any components
Patients with viral or fungal diseases of the skin
Cautions
For external use only; avoid contact with the eyes, lips, and mouth
May cause suppression of hypothalamic-pituitary-adrenal axis, leading to adrenal crisis in young patients or patients receiving large topical doses for prolonged periods
Discontinue use if irritation, redness, itching, swelling, or undue dryness occurs
Risk of secondary skin infections may increase
Incidence of Kaposi's sarcoma associated with prolonged corticosteroid treatments
Coadministration with other topical acne medications may increase skin irritation and dryness; avoid excessive sun exposure and use sunscreen
Avoid contact with hair and dyed fabrics (eg, pillow cases, towels), which may be bleached by this product
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Excretion in milk unknown; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Benzoyl Peroxide
- Elicits action by releasing active oxygen
- Effective in vitro against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones
- Elicits keratolytic and desquamative effect, which may contribute to its efficacy
Hydrocortisone
- Decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes
- Inhibits macrophage accumulation in inflamed areas
- Reduces leukocyte adhesion to capillary endothelium
- Reduces capillary wall permeability and edema formation
- Decreases complement components and antagonizes histamine activity and release of kinin from substrates
- Reduces fibroblast proliferation, collagen deposition, and subsequent scar tissue formation
Pharmacokinetics
Benzoyl peroxide
- Absorbed by the skin where it is converted to benzoic acid
Hydrocortisone
- Percutaneous absorption of topical steroids increased by occlusive dressing
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Formulary
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