Pharmalene B

Adapalene, benzoyl peroxide.

Each gram of gel contains: Adapalene 1 mg, Benzoyl peroxide 25 mg.

Pharmacology: Mechanism of action: Adapalene acts on retinoid receptors. Mechanistically, Adapalene binds to specific Retinoic acid nuclear receptors but it does not bind to the cytosolic receptor protein. Although the exact mode of action of Adapalene is unknown, it is suggested that topical Adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Benzoyl Peroxide is an antibacterial agent which is believed to act by oxidizing proteins, including bacterial proteins, and reducing the population of Propionibacterium acnes which are usually abnormally present in the acne-affected pilosebaceous unit. Therefore, Adapalene and Benzoyl Peroxide act through different, but complementary, mechanisms that affect different aspects of acne therapy.

Pharmalene B is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Apply a thin film of Pharmalene B to affected areas of the face and/or trunk once daily after washing with a mild or soapless cleanser. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek).
Avoid the eyes, lips and mucous membranes. Pharmalene B is not for oral, opthalmic, or intravaginal use.
The product can be used within 60 days after opened.

Patients with history of hypersensitivity to Adapalene, Benzoyl Peroxide or to any other component of this preparation.

Ultraviolet Light and Environmental Exposure: Exposure to sunlight should be minimized during the use of Pharmalene B. Use of sunscreen products and protective apparel (e.g. hat ) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with Pharmalene B.
Local Cutaneous Reactions: Erythema, scaling, dryness, and stinging/burning may be experienced with use of Pharmalene B. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to use a moisturizer, reduce the frequency of the application of Pharmalene B, or discontinued use.
Pharmalene B should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned. As with other Retinoids, use of waxing as a depilatory method should be avoided on skin treated with Pharmalene B.
Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
This product contains Propylene Glycol that may cause skin irritation.
If a reaction suggesting sensitivity to any component of the formula occurs, the use of Pharmalene B should be discontinued.
Pharmalene B should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.
Use in Pregnancy: Pregnancy category C. Pharmalene B should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Use in Lactation: It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use of Pharmalene B. Because many drugs are excreted in human milk, caution should be exercised when Pharmalene B is administered to a nursing woman.
Use in Children: Safety and effectiveness of Pharmalene B in pediatric patients under the age of 12 have not been established.

If skin irritation appears after application of Pharmalene B, the intensity is generally mild or moderate, with local tolerability signs and symptoms [erythema, dryness, scaling, burning and pain of skin (including stinging)] peaking during the first two weeks and then subsiding spontaneously.
Pharmalene B may cause the following adverse reactions, ranked in the list as follows by frequency and within each frequency grouping by decreasing medical seriousness.
Summary of adverse reactions: *The adverse reactions are classified by System Organ Class and frequency.
**Using the following convention: very common (greater than or equal to 1/10), common (greater than or equal to 1/100 to less than 1/10), uncommon (greater than or equal to 1/1,000 to less than 1/100), rare (greater than or equal to 1/10,000 to less than 1/1,000), very rare (less than 1/10,000), not known (cannot estimated from the available data).
Eye disorders: Not known: Eyelid oedema.
Respiratory, thoracic and mediastinal disorders: Not known: Throat tightness, dyspnoea.
Skin and subcutaneous disorders: Common: Irritative contact dermatitis, skin burning sensation, dry skin, skin irritation, erythema, skin exfoliation (scaling).
Uncommon: Pruritus, sunburn.
Not known: Anaphylactic reaction, urticaria, allergic contact dermatitis, swelling face, skin discoloration, pain of skin (e.g stinging pain), blistered skin, application site burn.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

Store below 30°C.

Acne Treatment Preparations

D10AD53 - adapalene, combinations ; Belongs to the class of topical retinoid preparations. Used in the treatment of acne.

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