Adapalene + Benzoyl peroxide
Indications
Adapalene & Benzoyl peroxide gel is
indicated for the topical treatment of acne vulgaris in patients 12
years of age and older.
Pharmacology
Adapalene & Benzoyl peroxide gel is
indicated for the topical treatment of acne vulgaris in patients 12
years of age and older. Adapalene binds to specific retinoic acid
nuclear receptors but does not bind to cytosolic receptor protein.
Biochemical and pharmacological profile studies have demonstrated that
Adapalene is a modulator of cellular differentiation, keratinization and
inflammatory processes. Adapalene binds with specific retinoic acid
nuclear receptors that normalize the differentiation of follicular
epithelial cells resulting in decreased microcomedone formation. Benzoyl
peroxide is an oxidizing agent with bacteriocidal and keratolytic
effects.
Dosage & Administration
Apply a thin film of Adapalene &
Benzoyl peroxide gel to affected areas of the face and/or trunk once
daily after washing. Use a pea-sized amount for each area of the face
(e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous
membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic,
or intravaginal use.
Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.
Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.
Interaction
Concomitant topical acne therapy should be
used with caution because a possible cumulative irritancy effect may
occur, especially with the use of peeling, desquamating, or abrasive
agents. No formal drug-drug interaction studies were conducted.
Contraindications
Should not be administered to individuals who are hypersensitive to any of its component.
Side Effects
Erythema, scaling, dryness, and stinging/
burning may occur. Most commonly reported adverse events are dry skin,
contact dermatitis, application site burning, application site
irritation, and skin irritation.
Pregnancy & Lactation
There are no well-controlled trials in
pregnant women treated with Adapalene and Benzoyl peroxide. Animal
reproduction studies have not been conducted with the combination gel or
Benzoyl peroxide. Furthermore, such studies are not always predictive
of human response; therefore, this preparation should be used during
pregnancy only if the potential benefit justifies the risk to the fetus.
It is not known whether Adapalene or Benzoyl peroxide is excreted in
human milk following use. Caution should be exercised when administered
to a nursing woman.
Precautions & Warnings
Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.
Therapeutic Class
Topical retinoid and related preparations
Storage Conditions
Store in a cool (below 25°C) and dry place
protected from light and moisture. Keep out of the reach of children.
Keep the tube tightly closed after use.
Showing 1 to 7 of 7 (1 Pages)