Aclene Plus Gel

Aclene Plus Gel is used for: Acne

Apply a thin film to affected areas of the face and/or trunk once daily in the evening after washing.

Child: >9 years: Apply thin film to affected facial areas and/or trunk in the evening after washing <9 years: Safety & efficacy has not been established.

For topical use only; not for ophthalmic, oral, or intravaginal use Avoid mucous membranes, eyes, and lips Apply pea-sized amount for each facial area (eg, chin, forehead, cheek)

Hypersensitive to any of the components.

Exposure to sunlight, including sunlamps, should be minimized during the use of adapalene and benzoyle peroxide 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 adapalene and benzoyle peroxide gel. Safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 9 years have not been established.

Pregnancy Available pharmacovigilance data in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; animal reproduction studies have not been conducted with the combination gel Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown; based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine; hence, maternal use is not expected to result in fetal exposure of the drug Lactation Adapalene gel, 0.3% There are no data on presence of adapalene topical gel or its metabolite in human milk, effects on breastfed infant, or effects on milk production; in animal studies, adapalene is present in rat milk with oral administration of the drug When a drug is present in animal milk, it is likely that the drug will be present in human milk; it is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown; based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine; any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases; there are no data on presence of benzoyl peroxide in human milk, its effects on breastfed infant or on milk production The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on the breastfed child from the medication or from the underlying maternal condition. To minimize potential exposure to the breastfed infant via breastmilk, use the medication on the smallest area of skin and for the shortest duration possible while breastfeeding; advise breastfeeding women not to apply the drug directly to the nipple and areola to avoid direct infant exposure

Adapalene: Increased irritation may occur with medicated or abrasive soaps, products with a pronounced drying effect and those containing alcohol or astringents. Benzoyl Peroxide: PABA sunscreens may transiently discolour fabric.

Side effects of Adapalene 0.1% + Benzoyl Peroxide 2.5% Topical : >10% Stinging/ burning (3-41%),Dryness (1-41%),Scaling (1-35%),Erythema (1-27%) 1-10% Contact dermatitis (3%),Application site burning (2%),Application site irritation (1%),Skin irritation (1%)

Adapalene binds to specific retinoic acid nuclear receptors which normalises the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Benzoyl peroxide has mild keratolytic effect and antimicrobial activity which is attributed to its oxidative property. It is active against S.epidermidis and P.acne.

Aclene Plus 0.1%+2.5% Gel manufactured by Drug International Ltd.. Its generic name is Adapalene 0.1% + Benzoyl Peroxide 2.5% Topical. Aclene Plus is availble in Bangladesh. Farmaco BD drug index information on Aclene Plus Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.