Benzac 0.04

INDICATIONS

Benzoyl Peroxide is indicated for the topical treatment of mild to moderate acne vulgaris. Benzoyl Peroxide may be used with other acne treatments including retinoic acid products, antibiotics and sulfur/salicylic acid containing preparations.

PHARMACOLOGY

Acne vulgaris is caused by inflammation in the pilosebaceous gland. Acne is generally caused by increased excretion of sebum from pilosebaceous glands, endocrine factors such as androgenic hormones, keratin developing around follicles, bacterial growth, and inflammation. These factors contribute to the formation of comedones (whiteheads and blackheads). The peroxide bond of benzoyl peroxide is cleaved to form 2 benzoyloxy radicals. These radicals interact nonspecifically with bacterial proteins, interfering with their function, and survival of the bacteria. Over time, free radical interactions with bacterial proteins lead to decreased keratin and sebum around follicles. Benzoyl peroxide can also increase the turnover rate of epithelial cells, leading to skin peeling, and breaking down comedones.

DOSAGE & ADMINISTRATION

Shake well before using. It is recommended that therapy be initiated with Benzoyl Peroxide, washing the affected areas once a day during the first week, and twice a day thereafter as tolerated. Wet skin areas to be treated; apply Benzoyl Peroxide Wash, work to a full lather, rinse thoroughly and pat dry. Frequency of use should be adjusted to obtain the desired clinical response. Close cap tightly after use. Children: Safety and effectiveness in children below the age of 12 have not been established.

INTERACTION

There is no known interaction with other medications which might be used cutaneously and concurrently with Benzoyl Peroxide; however, drugs with desquamative, irritant and drying effects should not be used concurrently with Benzoyl Peroxide gel.

SIDE EFFECTS

Allergic confact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. If excessive scaling, erythema or edema occurs the use of Benzoyl Peroxide should be discontinued and appropriate therapy instituted. To hasten resolution of adverse effects, cool compresses may be used. After reaction clears, a reduced dosage schedule may often be resumed if the reaction is judged not to be due to allergenicity.

PREGNANCY & LACTATION

Pregnancy: Category C. Animal reproductive studies have not been conducted with benzoyl peroxide. It is also 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.

PRECAUTIONS & WARNINGS

For external use only. Keep out of reach of children. Avoid contact with eyes, eyelids, lips and mucous membranes. If inadvertent contact occurs, rinse area thoroughly with water. Contact with colored material, including fabric and hair, may result in discoloration. When using Benzoyl Peroxide, avoid unnecessary sun exposure and use a sunscreen. In case of accidental ingestion, seek professional assistance or contact a poison control centerimmediately.Information for Patients:

Avoid contact with eyes, eyelids, lips and mucous membranes.
May discolor hair and fabrics.
Avoid unnecessary sun exposure and use a sunscreen.
Use of oil-free make-up recommended.
If severe irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is not known. Benzoyl peroxide has not been found to be mutagenic (Ames test) and there are no published data indicating that it impairs fertility.

THERAPEUTIC CLASS

Acne treatment preparations

STORAGE CONDITIONS

Store in a cool and dry place, protected from light.