Monograph: |
BENZOYL PEROXIDE
DESCRIPTION:
ACTIONS/CLINICAL PHARMACOLOGY:
The mechanism of action of benzoyl peroxide is not totally understood but its
antibacterial activity against Propionibacterium Acnes is thought to be a major
mode of action. In addition, patients treated with benzoyl peroxide show a
reduction in lipids and free fatty acids and mild desquamation (drying and
peeling activity) with a simultaneous reduction in comedones and acne lesions.
Little is known about the percutaneous penetration, metabolism, and excretion of
benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by
the skin is metabolized to benzoic acid and then excreted as benzoate in the
urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in
humans.
INDICATIONS AND USAGE:
BENZAC 5 and 10 and BENZAC W 2 1/2, 5 and 10 are indicated for the topical
treatment of acne vulgaris. BENZAC W WASH 5 and 10 are indicated for the topical
treatment of mild to moderate acne vulgaris. In severe complicated acne. BENZAC
W WASH 5 and 10 may be used as an adjunct to other therapeutic regimens.
BENZAC AC 2 1/2, 5 and 10 and BENZAC AC WASH 2 1/2, 5 and 10 are indicated for
the topical treatment of acne vulgaris.
CONTRAINDICATIONS:
These preparations are contraindicated in patients with a history of
hypersensitivity to any of their components.
PRECAUTIONS:
GENERAL: For external use only. If severe irritation develops, discontinue use
and institute appropriate therapy. After the reaction clears, treatment may
often be resumed with less frequent application. These preparations should not
be used in or near the eyes or on mucous membranes.
INFORMATION FOR PATIENTS: Avoid contact with eyes, eyelids, lips and mucous
membranes. If accidental contact occurs, rinse with water. Avoid contact with
eyes, hair or carpet. Benzoyl peroxide will cause bleaching. If excessive
irritation develops, discontinue use and consult your physician.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Data from several studies
employing a strain of mice that are highly susceptible to developing cancer
suggest that benzoyl peroxide acts as a tumor promotor. The clinical
significance of these findings to humans is unknown. Benzoyl peroxide has not
been found to be mutagenic (Ames Test) and there are no published data
indicating it impairs fertility.
PREGNANCY: TERATOGENIC EFFECTS: Pregnancy Category C: Animal reproduction
studies have not been conducted with benzoyl peroxide. It is not known whether
benzoyl peroxide can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant
woman only if clearly needed. There are no available data on the effect of
benzoyl peroxide on the later growth, development and functional maturation of
the unborn child.
NURSING MOTHERS: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when
benzoyl peroxide is administered to a nursing woman.
PEDIATRIC USE: Safety and effectiveness in children have not been established.
ADVERSE REACTIONS:
Allergic contact dermatitis and dryness have been reported with topical benzoyl
peroxide therapy.
OVERDOSAGE:
If excessive scaling, erythema or edema occur, the use of this preparation
should be discontinued. To hasten resolution of the adverse effects, cool
compresses may be used. After symptoms and signs subside, a reduced dosage
schedule may be cautiously tried if the reaction is judged to be due to
excessive use and not allergenicity.
DOSAGE AND ADMINISTRATION:
BENZAC AC 2 1/2, 5 or 10 should be applied once or twice daily to cover affected
areas after washing with a mild cleanser and water.
BENZAC AC WASH 2 1/2, 5 or 10. Wash once or twice daily avoiding contact with
the eyes and mucous membranes. Wet the area of application. Apply BENZAC AC WASH
2 1/2, 5 or 10 to the hands and wash the affected areas. Rinse with water and
pat dry.
BENZAC 5 OR 10 OR BENZAC W 2 1/2, 5 OR 10 should be applied once or twice daily
to cover affected areas after washing with a mild cleanser and water. Wash with
BENZAC W Wash 5 OR 10 once or twice daily, avoiding contact with eyes and mucous
membranes. Wet the area of application. Apply BENZAC W Wash 5 OR 10 to the hands
and wash the affected areas. Rinse with water and dry. The degree of drying and
peeling can be adjusted by modification of the dosage schedule.
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