DIFACLEAR GEL 0.1%W/W

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.

Active Ingredient / Synonyms

6-(3-(1-Adamantyl)-4-methoxyphenyl)-2-naphthoic acid | Adaferin | Adapaleno | Adapalenum | Differine | Adapalene |

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.

Pharmacodynamics

Adapalene is a chemically stable retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.

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:

Not Available

Metabolism:

Metabolized mainly by O-demethylation, hydroxylation and conjugation, and excretion is primarily by the biliary route.

Elimination:

Excretion appears to be primarily by the biliary route.

Half-life

Not Available

Clearance

Not Available

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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

DIFACLEAR GEL 0.1%W/W was registered with Health Science Authority of Singapore by RANBAXY (MALAYSIA) SDN. BHD.. It is marketed with the registration number of SIN15136P with effective from 2016-12-13.

This product contains 1mg/g of Adapalene in the form of GEL.

The medicine was manufactured by Sun Pharmaceutical Industries LTD in INDIA

It is a has been granted the exemptions for supply without a presciption if it met certain criteria.

Reclassified Info

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: D10AD03

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