|Composition||:||Adaclean 0.3% Each 1 g gel contains: Adapalene 3mg.|
|Excipients||:||Vehicle consisting of: Carbomer 940, Edetate disodium, Methylparaben, Poloxamer 182, Propylene glycol, Purified water, and Sodium hydroxide. May contain Hydrochloric Acid to adjust pH.|
|Pharmacodynamics||:||Adapalene is a retinoid-like compound which, in vivo and in vitro models of inflammation, has been demonstrated to possess anti-inflammatory properties. adapalene binds like tretinoin to specific retinoic acid nuclear receptors but, unlike tretinoin not to cytosolic receptor binding proteins.
The mode of action of adapalene is suggested to be a normalization of differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
|Pharmacokinetics||:||Absorption of adapalene through human skin is low, and excretion is primarily by the biliary route.|
|Indications||:||Adaclean is proposed for the cutaneous treatment of mild to moderate acne vulgaris where comedones, papule and pustules predominate .Adaclean Gel is best suited for use on dry and fair skin. Acne of the face, chest or back appropriate for treatment.|
|Contraindications||:||Hypersensitivity to the active substance or to any of the excipients.|
|Side Effects||:||Skin and subcutaneous tissue disorders:
Common: Dry skin, skin irritation, skin burning sensation, erythema.
Uncommon: Dermatitis contact, skin discomfort, sunburn, pruritus, skin exfoliation, acne.
|Warnings & Precautions||:||If a reaction suggesting sensitivity or severe irritation occurs, use of the medication should be discontinued. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, to discontinue use temporarily, or to discontinue use altogether. Adapalene should not come into contact with the eyes, mouth, angle of the nose or mucous membranes.
If product enters the eye, wash immediately with warm water. The product should not be applied to either broken (cut and abrasions), sunburnt or eczematous skin, nor should it be used in patients with severe acne, or acne involving large areas of the body.
Exposure to sunlight and artificial UV irradiation, including sunlamps, should be minimized during use of adapalene.
Patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.
|Dosage & Administration||:||Adaclean should be applied to the acne affected areas once a day before retiring and after washing. A thin film of should be applied, with the fingertips, avoiding the eyes and lips. Cleanse area with a mild or soapless cleanser before applying this medication Ensure that the affected areas are dry before application.
Since it is customary to alternate therapies in the treatment of acne, it is recommended that the physician assess the continued improvement of the patient after three months of treatment with Adaclean.
With patients for whom it is necessary to reduce the frequency of application or to temporarily discontinue treatment frequency of application may be restored or therapy resumed once it is judged that the patient can again tolerate the treatment.
If patients use cosmetics, these should be non-comedogenic and non-astringent.
Wax epilation should not be performed on treated skin due to the potential for skin erosions.
During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of this medication on previously unseen lesions and should not be considered a reason to discontinue therapy.
Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.
The safety and effectiveness of Adaclean have not been studied in children below 12 years of age.
|Pregnancy & lactations||:||Pregnancy: category c
Animal studies by the oral route have shown reproductive toxicity at high systemic exposure. Clinic experience with locally applied adapalene in pregnancy is limited but the few available data do not indicate harmful effects on pregnancy or on the health of the foetus exposed in early pregnancy. Due to the limited available data and because a very weak cutaneous passage of adapalene is possible, Adapalene should not be used during pregnancy. In case of unexpected pregnancy, treatment should be discontinued.
No study on animal or human milk transfer was conducted after cutaneous application of Adapalene.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to Adapalene negligible. Adapalene can be used during breastfeeding. To avoid contact exposure of the infant, application of Adaclean to the chest should be avoided when used during breast-feeding.
|Drug interactions||:||There are no known interactions with other medications which might be used cutaneously and concurrently with Adapalene; however, other retinoids or drugs with a similar mode of action should not be used concurrently with Adapalene.
Adapalene is essentially stable to oxygen and light and is chemically non-reactive. The safety of using Adapalene during repeated exposure to sunlight or UV irradiation has not been established in either animals or man. Exposure to excessive sunlight or UV irradiation should be avoided.
Absorption of adapalene through human skin is low and therefore interaction with systemic medications is unlikely. There is no evidence that the efficacy of oral drugs such as contraceptives and antibiotics is influenced by the cutaneous use of Adapalene.
Adapalene has a potential for mild local irritation, and therefore it is possible that concomitant use of peeling agents, astringents or irritant products (aromatic and alcoholic agents) may produce additive irritant effects. However, cutaneous anti acne treatment e.g. erythromycin (up to 4%) or clindamycin phosphate (1% as the base) solutions or benzoyl peroxide water based gels up to 10% may be used in the morning when Adapalene is used at night as there is no mutual degradation or cumulative irritation.
|Overdosage||:||Adaclean is not to be taken orally and is for cutaneous use only.
If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.
The accurate oral dose of Adaclean required to produce toxic effects in mice is greater than 10 g/kg. Nevertheless unless the amount accidentally ingested is small, an appropriate method of gastric emptying should be considered.
|Storage||:||store at temperature below 25°C. Don’t Freeze.|
|Packaging||:||Metallic tube of 30 g gel in a carton box with leaflet.|