|Composition||:||Adaclean Plus 0.1%: Each 1 g Gel contains: Adapalene 1 mg
Benzoyl Peroxide 25 mg
|EXCIPIENTS||:||Vehicle consisting of (Acrylamide, Poly Sorbate 80), Docusate Sodium, Edetate Disodium, Glycerine, Poloxamer, Propylene Glycol, Purified Water.|
|Mechanism of Action||:||Adapalene:
Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes.
Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.
|Pharmacokinetic properties||:||Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.|
|Indications||:||Adaclean Plus is indicated for the topical treatment of acne vulgaris.|
|Contraindications||:||Hypersensitivity to the active substances or to any of the excipients.|
|Side effects||:||Common: Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation, erythema, skin exfoliation (scaling).
Uncommon: Pruritus, sunburn.
|WARNINGS & PRECAUTIONS||:||Ultraviolet Light and Environmental Exposure
Exposure to sunlight, including sunlamps, should be minimized during the use of gel. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. 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 gel.
Local Cutaneous Reactions
Erythema, scaling, dryness, and stinging/burning may be experienced with use of gel. 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. Irritant and allergic contact dermatitis may occur. Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application gel , or discontinue use.
Should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "Waxing" as a depilatory method should be avoided on skin treated with Adaclean Plus gel.
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, limes, or spices).
|Pregnancy & lactations||:||Pregnancy Category C.
Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Caution should be exercised when Gel is administered to a nursing woman.
|Pediatric Use||:||Safety and effectiveness of gel in pediatric patients under the age of 9 years have not been established.|
|DRUGS INTERACTION||:||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.
Absorption of adapalene through human skin is low , and therefore interaction with systemic medicinal products is unlikely.
The percutaneous penetration of benzoyl peroxide in the skin is low and the drug substance is completely metabolized into benzoic acid which is rapidly eliminated.
|Dosage & Administration||:||For topical use only; Adaclean Plus Gel is not for oral, ophthalmic, or intravaginal use. Apply a thin film of Gel to affected areas of the face and/or trunk once daily after washing. Use a pea sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes.
If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether.
The duration of treatment should be determined by the Doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment.
|STORAGE CONDITIONS||:||Store at temperature below 25ºC, Protect from light and moisture.|
|Packaging||:||Metallic tube of 30 g Gel in a carton box with leaflet.