Product Information
Registration Status: ActiveSIN15460P
EPIDUO FORTE GEL 0.3%/2.5% is approved to be sold in Singapore with effective from 2018-04-03. It is marketed by GALDERMA SINGAPORE PTE LTD, with the registration number of SIN15460P.
This product contains Adapalene 0.30 % W/W, and Benzoyl Peroxide 2.5 % W/W in the form of GEL. It is approved for TOPICAL use.
This product is manufactured by G PRODUCTION INC in CANADA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Adapalene is a topical retinoid primarily used in the treatment of acne and is also used (off-label) to treat keratosis pilaris as well as other skin conditions. It is currently marketed by Galderma under the trade names Differin in some countries, and Adaferin in India.
Indication
For the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.
Mechanism of Action
Mechanistically, adapalene binds to specific retinoic acid nuclear receptors (gamma and beta) and retinoid X receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Pharmacokinetics
- Absorption
- Absorption of adapalene through human skin is low. Only trace amounts (
- Distribution
- Metabolism
- Metabolized mainly by O-demethylation, hydroxylation and conjugation, and excretion is primarily by the biliary route.
- Elimination
Toxicity
The acute oral toxicity of adapalene in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
Active Ingredient/Synonyms
6-(3-(1-Adamantyl)-4-methoxyphenyl)-2-naphthoic acid | Adaferin | Adapaleno | Adapalenum | Differine | Adapalene |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
Benzoyl peroxide (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications. In medicine, benzoyl peroxide is used as a topical treatment for acne, either in combination with antibiotics or as a single agent. These products are available over-the-counter or by prescription in gels, creams or liquids at concentrations of 2.5%, 5% or 10%. Benzoyl peroxide is also used for bleaching flour or hair, teeth whitening, for cross-linking polyester resins, and many other chemical uses. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system.
Indication
Benzoyl peroxide is indicated for the treatment of mild to moderate acne vulgaris and rosacea. Combined with other agents, it may be used in the treatment of more severe acne.
Mechanism of Action
Benzoyl peroxide decomposes to release oxygen after topical application. This oxygen acts as a bactericidal agent towards Proprionibacterium acnes, the bacteria present in acne vulgaris. Benzoyl peroxide also increases the turnover rate of epithelial cells, thereby peeling the skin and promoting the resolution of comedones.
Pharmacokinetics
- Absorption
- Benzoyl peroxide is absorbed percutaneously into the dermal layer of the epithelium. It is then metabolized to benzoic acid which can be absorbed systemically. There is no systemic absorption of benzoyl peroxide itself.
- Distribution
- Benzoyl peroxide is not absorbed or distributed systemically after topical application.
- Metabolism
- Benzoyl peroxide undergoes metabolism by keratinocytes in the epidermis. Initially, the peroxide bond is cleaved to form benzoyloxyl radicals. It is thought this reaction may be copper-catalyzed. The benzoyloxyl radicals may then fragment to form carbon dioxide and a phenyl radical. Alternatively, the radicals may gain a hydrogen atom from biomolecules forming the more stable and primary metabolite, benzoic acid.
- Elimination
Clearance
Benzoyl peroxide is not absorbed into systemic circulation after topical application. Its primary metabolite, benzoic acid, is cleared rapidly via renal excretion and hepatic conjugation is thought to be bypassed.
Toxicity
There is no evidence to support carcinogenicity in humans. Benzoyl peroxide may cause contact hypersensitivity, stinging and burning sensations when applied topically. It should not be applied under occlusive dressings due to risk of sensitization. During processing and formulation, exposure to concentrations higher than 12.2 mg/cu may cause irritation to the nose and/or throat.
Active Ingredient/Synonyms
Benzoyl benzenecarboperoxoate | Bepio | Benzoyl peroxide |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.