Product Information
Registration Status: ActiveDIFACLEAR GEL 0.1%W/W is approved to be sold in Singapore with effective from 2016-12-13. It is marketed by RANBAXY (MALAYSIA) SDN. BHD., with the registration number of SIN15136P.
This product contains Adapalene 1mg/g in the form of GEL. It is approved for TOPICAL use.
This product is manufactured by Sun Pharmaceutical Industries LTD in INDIA.
It is a has been granted the exemption for supply without a presciption if it met certain criteria.
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 (<0.25 ng/mL) of parent substance have been found in the plasma of acne patients following chronic topical application of adapalene in controlled clinical trials
- 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.