Each gram contains: Adapalene 1 mg.
Pharmacology: Pharmacodynamics: Topical: The exact mechanism is not known. Adapalene exhibits some retinoic acid-like activity but it also has additional effects. It is thought that adapalene reduces important features of the pathology of acne vulgaris by normalizing the differentiation of follicular epithelial cells and keratinization to prevent microcomedone formation, similar to the mechanism of retinoic acid. Unlike retinoic acid, adapalene selectively binds to some nuclear retinoic acid receptors (RARs) and does not bind to cellular receptors called cytosolic retinoic acid binding proteins (CRABPs). It is hypothesized that by selectively binding to certain nuclear retinoic acid. Also, adapalene may help reduce cell-mediated inflammation, an effect demonstrated by in vitro studies. Adapalene decreases formation of comedones and inflammatory and non-inflammatory acne lesions.
Pharmacokinetics: Absorption: Topical bioavailability is low.
Elimination: Topical: Biliary route is major route of excretion.
The elimination half-life is 17.2 ± 10.2 hour.
Topical treatment of acne vulgaris.
After washing the affected area and drying, apply a thin film enough to cover the entire affected skin areas once daily.
Patients with hypersensitivity of this drug.
Patients with cuts, abrasions, eczematous or sunburned skin.
Patients unrecovered from sunburn is not recommended to use this drug. Avoid contact with the eyes, lips, angles of nose, and mucous membranes.
Patients with hypersensitivity or allergy of propylene glycol.
Patients with high levels of sun exposure and those with inherent sensitivity to sun.
General Precautions: If hypersensitivity or severe troubles occur, reduce times of use or discontinue according to the symptoms.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.
Avoid with other potentially irritating topical products (abrasive soaps/cleansers, soaps/cosmetics with strong drying effect, products with high concentrations of alcohol, astringents, spices, or limes).
In case of applying other acne treatment drug such as Erythromycin (below 4%), 1% Clindamycin Phosphate or Benzoyl Peroxide (below 10%) in the morning, patients may use this drug jointly in the evening.
Minimize exposure to sunlight including sunlamps. Use sunscreen products and protective clothing over treated areas if exposure cannot be avoided. Avoid use before/after, or on the day of exposure of strong sunlight.
Even if increasing the frequency of applying this drug, the effect is not enhanced or reaction is not faster, and certain cutaneous signs and symptoms such as redness, scaling, irritation may be experienced during treatment.
If the patient applies other topical scaling treatment before the treatment of this drug, be instructed to use this drug after recovery of skin irritation.
Patients with hypersensitivity of propylene glycol or Methyl ρ-Hydroxybenzoate contained in this drug as excipients should be instructed to be cautious.
Pregnancy: Cutaneous route teratology studies conducted in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day, up to 150 times the maximal daily human topical dose exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats.
There are no adequate and well-controlled studies in pregnant women. Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 10-40% of patients.
Pruritus or burning immediately after application also occurs in approximately 20% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter.
As this drug has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution.
As this drug is stable to oxygen and light and chemically non-reactivity, even in combined treatment with other acne drugs such as clindamycin or benzoyl peroxide, interactions do not occur.
As absorption quantity of this drug through skin is little, there is less possibilities to interact with the orally delivered drugs. But avoid the combined treatment with other retinoid or similar mechanism action drugs.
Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with this drug.
Store at temperatures not exceeding 30°C.
D10AD03 - adapalene ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
Adrylex topical gel 1 mg/g
15 g x 1's
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