Aclene Cream
Adapalene 0.1% Topical
0.1%
Drug International Ltd.
| Pack size | 10gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 60.00 AED |
Indications
Aclene Cream is used for:
Acne, Keratosis pilaris
Adult Dose
Adult: Topical As 0.1% soln/cream/gel: Apply once daily at night after cleansing.
Child Dose
Renal Dose
Administration
Topical Administration
Apply small (pea-sized) amount sparingly to entire face after cleansing with nonmedicated cleanser
For topical use only; not for ophthalmic, oral, or intravaginal use
Avoid mucous membranes, eyes, and lips
Contra Indications
Hypersensitivity to adapalene or any of its components
Precautions
Minimize UV light exposure; use sunscreen and protective clothing
Extreme weather (eg, wind, cold) may cause skin irritation
Adverse reaction risk higher during first month of treatment; generally subsides with use
Do not apply product to abrasions or cuts or to eczematous or sunburned skin
Skin irritation: Apply moisturizer, reduce application frequency, or discontinue
Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps, and cleansers, exfoliants, sulfur, resorcinol, salicylic acid)
Anaphylaxis, angioedema, urticaria, face edema, eyelid edema, lip swelling, and pruritus sometimes requiring medical treatment have been reported during postmarketing use of adapalene; advise patients to stop using medication and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment
Pregnancy-Lactation
Pregnancy
Available data from clinical trials with Adapalene Lotion use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
Animal data
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 122 and 243 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations
Lactation
There are no data on the presence of topical adapalene lotion or metabolite in human milk, its effects on breastfed infants, or 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; 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 therapy or from the underlying maternal condition
To minimize potential exposure to the breastfed infant via breastmilk, use the smallest area of skin and for the shortest duration possible while breastfeeding; avoid application to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child
Interactions
Increased irritation may occur with medicated or abrasive soaps, products with a pronounced drying effect and those containing alcohol or astringents.
Contraindicated (0)
Serious - Use Alternative (5)
aminolevulinic acid oral
aminolevulinic acid topical
multivitamins
multivitamins, vision
vitamin A
Adverse Effects
Side effects of Adapalene 0.1% Topical :
>10%
Dryness (1-45%),Scaling (1-44%),Burning/stinging (4-29%),Erythema (0.5-26%)
1-10%
Skin discomfort (6%),Pruritus (2%),Desquamation (2%),Sunburn (1%)
<1%
Acne flare,Conjunctivitis,Contact dermatitis,Eczema,Erythema,Eyelid edema,Rash,Skin discoloration
Mechanism of Action
Adapalene binds to specific retinoic acid nuclear receptors which normalises the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Note
Aclene 0.1% Cream manufactured by Drug International Ltd.. Its generic name is Adapalene 0.1% Topical. Aclene is availble in Bangladesh.
Farmaco BD drug index information on Aclene Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.