& & Adapalene gel is indicated for the topical treatment of moderately severe acne vulgaris.
* Dosage and administration:
& & Adapalene gel should be applied to the affected areas of the skin, once daily at night time,
& & avoiding the eyes and lips.
& & – The skin should be cleaned and dried before the application of the gel.
& & – A thin film of the gel should be applied to the skin areas where acne lesions appear, using
& & enough to cover the entire affected areas lightly.
& & – A mild transitory sensation of warmth or slightly stinging may occur shortly after the application
& & of Adapalene gel.
& & – Therapeutic results should be noticed after 8 to 12 weeks of treatment.
* Warnings and precautions:
& & – Certain cutaneous signs such as erythema, dryness, scaling, burning, or pruritus may
& & appear with the use of Adapalene gel. Depending on the severity of these side effects,
& & patients should be instructed to reduce the frequency of application or discontinue its use.
& & In any case, if a severity reaction or chemical irritation occurs, the use of the gel should
& & be discontinued.
& & – Avoid contact with eyes, lips, angles of the nose, and mucous membranes. In case of
& & accidental exposure, wash well with warm water.
& & – Moisturizers may be used if necessary, however, avoid products containing alpha-hydroxy
& & glycolic acid.
& & – The product should not be applied to cuts, abrasions or sun burned skin. The patient
& & should wait for complete recovery before continuing administration.
& & – Exposure to sunlight should be minimized during application of Adapalene. Sunscreens &&
& & protective clothing over treated areas should be recommended when exposure cannot be
& & avoided.
& & – Safety for use for children under the age of 12 has not been established.
& & – The gel should be applied at night.
& & – The gel is for topical application only && not for ophthlamic, oral or intravaginal use.
& & – During the early weeks of therapy, an apparent exacerbation of acne may occur due to
& & the action of the medication on previously unseen lesions && should not be considered a
& & reason to discontinue therapy.
& & This product should not be administered to individuals who are hypersensitive to Adapalene
& & or any of the components in the gel vehicle.
* Pregnancy and lactation:
& & – Adapalene gel should be used during pregnancy only if the potential benefit justifies the potential
& & risk to the fetus.
& & – It is not known that Adapalene is excreted in human milk, so caution should be exercised when
& & Adapalene gel is administered to a nursing woman.
ADAPALENE 0.1% (0.1GM/100GM)