Pacnex

Medimetriks Pharmaceuticals, Inc.
Groupe PARIMA, Inc.

Pacnex(4.25% Benzoyl Peroxide)LP Cleansing Pads

FULL PRESCRIBING INFORMATION

DESCRIPTION: Pacnex (7% Benzoyl Peroxide) HP Cleansing Pads and Pacnex (4.25% Benzoyl Peroxide) LP Cleansing Pads are intended for topical administration and contain Benzoyl Peroxide for use in the treatment of acne vulgaris.
Benzoyl Peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl Peroxide (C₁₄H₁₀O₄) is represented by the following chemical structure:

Each pad of Pacnex HP Cleansing Pads contains 70 mg of Benzoyl Peroxide and Pacnex LP Cleansing Pads contains 42.5 mg of Benzoyl Peroxide in a formulation consisting of: aloe, carbomer interpolymer type A, cetyl alcohol, disodium oleamido MEA-sulfosuccinate, edetate disodium, glycerin, glyceryl stearate and PEG100 stearate, green tea, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium coco-sulfate, sodium lauroamphoacetate, xanthan gum.

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 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.

Uses

INDICATIONS AND USAGE:
Pacnex HP Cleansing Pads and Pacnex LP Cleansing Pads 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.

WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen.

PRECAUTIONS: General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After 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. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. 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 is highly susceptible to developing cancer suggest that Benzoyl Peroxide acts as a tumor promoter. 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 occurs, 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: Pacnex (7% Benzoyl Peroxide) HP and Pacnex (4.25% Benzoyl Peroxide) LP: Apply to affected areas once or twice a day, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, control by rinsing off cleanser sooner or using less often.

HOW SUPPLIED:
Pacnex HP Cleansing Pads contain 60 foil pouches, each with a single-use medicated pad (6 g each), NDC 43538-140-60.

Pacnex LP Cleansing Pads contain 60 foil pouches, each with a single-use medicated pad (6 g each), NDC 43538-150-60.

Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:

MEDIMETRIKS
PHARMACEUTICALS, INC.

363 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com


Manufactured by:
Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA