Generic Name: Adapalene Gel
Composition
Active ingredient: Adapalene
Description: A white translucent gel
Indications: The product can be used to treat common acne such as acne vulgaris, papule, pustule. It also can be used to treat acne vulgaris on the face, breast and back.
Specification: 0.1%
Dosage and Administration:
A thin film of Adapalene Gel should be applied to the affected areas of the skin once daily in the evening, after washing gently and till the affected areas dryness. The patients who should reduce the frequency of application of Adapalene gel or suspend the product may recover the the frequency of application of Adapalene gel when the patients tolerance to Adapalene was recovered. Please don't use the cosmetic which can induce the acne.
Contraindications: Patients who is hypersensitivity to Adapalene or excipients should be forbiden.
Precautions:
1. If a reaction suggesting sensitivity or chemical irritation occurs, the medication should be stopped using. After being confirmed the degree of local irritation reaction the patients should be reduced the frequency of application of Adapalene gel or should be suspended the product.
2. Exposure to sunlight, including sunlamps, dosage should be minimized during therapy. Patients who normally experience high levels exposure to sunlight, and those with inherent sensitivity to sun, should be warned to caution especially. Use of sunscreen products and protective clothing over treated areas is recommended when sunlight cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene gel.
3. Avoid contacting with the eyes, lips, oral, angles of the nose, inner canthus and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. And it should not be used to the very severe acne or eczematous skin lesion. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with adapalene gel.
For pregnant and lactation women:
The efficacy of Adapalene Gel in pregnancy has not been established. So the product should not be used during the pregnancy.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adapalene Gel is administered to a nursing woman. Please don't use the product on the breast.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Geriatric Use: Clinical studies of Adapalene Gel include subjects 12~30 age, so it is not known whether the subjects not less than 65 years of age respond differently than the younger subjects.
Overdodage:
Adapalene Gel is intended for topical use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur.
Pharmacology and Toxicology:
Adapalene acts on retinoid. Inflammatory in vivo and vitro model have been established. The chemical structure of Adapalene is stability and it is difficult to decompose in the air and sunlight. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein.
Storage: Protect in tightly closed containers, stored in a cool and dark (not more than 20º C) place.
Package: PE-Al-PE composite tube, 5g/tube/box, 15g/tube/box, 30g/tube/box
Shelf life: 24 months
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