국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ADAPALENE; BENZOYL PEROXIDE
ZUELLIG PHARMA SDN BHD
ADAPALENE; BENZOYL PEROXIDE
15 gm; 5 gm mcg/mL; 15 gm mcg/mL; 30 gm
LABORATOIRES GALDERMA
_Consumer Medication Information Leaflet (RiMUP) _ EPIDUO ® GEL Adapalene / Benzoyl peroxide (0.1%w/w / 2.5%w/w) WHAT IS IN THIS LEAFLET 1. What Epiduo Gel is used for 2. How Epiduo Gel works 3. Before you use Epiduo Gel 4. How to use Epiduo Gel 5. While you are using it 6. Side Effects 7. Storage and Disposal of Epiduo Gel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT EPIDUO GEL IS USED FOR Epiduo Gel is used for the treatment of acne. HOW EPIDUO GEL WORKS Epiduo Gel combines two active substances, which act through different, but complementary, mechanisms of action. ADAPALENE : Adapalene is a chemically stable, naphthoic acid derivative with retinoid- like activity. Biochemical and pharmacological profile studies have demonstrated that adapalene acts in the pathology of Acne vulgaris: it is a potent modulator of cellular differentiation and keratinisation and it has anti- inflammatory properties. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors. Current evidence suggests that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Adapalene inhibits the chemotactic (directional) and chemokinetic (random) responses of human polymorphonuclear leucocytes in in vitro assay models; it also inhibits the metabolism of arachidonic acid to inflammatory mediators. In vitro studies have shown inhibition of the AP-1 factors and the inhibition of the expression of toll like receptors 2. This profile suggests that the cell mediated inflammatory component of acne is reduced by adapalene. BENZOYL PEROXIDE : Benzoyl peroxide has been shown to have antimicrobial activity; particularly against P. acnes, which is abnormally present in the acne-affected pilosebaceous unit. Additionally, benzoyl peroxide has demonstrated exfoliative and keratolytic activities. Benzoyl peroxide is also sebostatic, counteracting the excessive sebum production associated with acne. BEFORE YOU USE EPIDUO 전체 문서 읽기
POM only For Topical Use only Name of Medicinal Product Epiduo 0.1%/2.5% gel Active Ingredients 1g of gel contains: Adapalene 1 mg (0.1%) Benzoyl Peroxide 25 mg (2.5%) Dosage Form Gel Product Description A white to very pale yellow opaque gel Pharmacodynamics Pharmacotherapeutic group: Anti-Acne Preparations for Topical Use ATC code: D10AD53 Mechanism of action and Pharmacodynamic effects: EPIDUO combines two active substances . which act through different, but complementary, mechanisms of action. -Adapalene: Adapalene is a chemically stable, naphthoic acid derivative with retinoid-like activity. Biochemical and pharmacological profile studies have demonstrated that adapalene acts in the pathology of Acne vulgaris: it is a potent modulator of cellular differentiation and keratinisation and it has anti-inflammatory properties. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors. Current evidence suggests that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Adapalene inhibits the chemotactic (directional) and chemokinetic (random) responses of human polymorphonuclear leucocytes in in vitro assay models; it also inhibits the metabolism of arachidonic acid to inflammatory mediators. In vitro studies have shown inhibition of the AP-1 factors and the inhibition of the expression of toll like receptors 2. This profile suggests that the cell mediated inflammatory component of acne is reduced by adapalene. - Benzoyl peroxide: Benzoyl peroxide has been shown to have antimicrobial activity; particularly against P. acnes, which is abnormally present in the acne-affected pilosebaceous unit. Additionally benzoyl peroxide has demonstrated exfoliative and keratolytic activities. Benzoyl peroxide is also sebostatic, counteracting the excessive sebum production associated with acne. Clinical efficacy of Epiduo in patients aged 12 years and older: The safety and efficacy of EPIDUO applied once daily for the treatment of acne vul 전체 문서 읽기