Product Information
Registration Status: ActiveROACCUTANE CAPSULE 10mg is approved to be sold in Singapore with effective from 1990-10-07. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN04920P.
This product contains Isotretinoin 10mg in the form of CAPSULE, LIQUID FILLED. It is approved for ORAL use.
This product is manufactured by Catalent Germany Eberbach GmbH in GERMANY.
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.
Description
Isotretinoin is a medication used for the treatment of severe acne. It is sometimes used in prevention of certain skin cancers. It is a retinoid, meaning it derives from vitamin A and is found in small quantities naturally in the body. Isotretinoin binds to and activates nuclear retinoic acid receptors (RAR), thereby regulating cell proliferation and differentiation. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization.
Indication
For the treatment of severe recalcitrant nodular acne
Mechanism of Action
Isotretinoin noticeably reduces the production of sebum and shrinks the sebaceous glands. It stabilises keratinization and prevents comedones from forming. It also reduces inflammation in moderate-severe inflammatory acne. The exact mechanism of action is unknown, however it is known that it alters DNA transcription.
Clearance
* 96 +/- 6.27 L/hr [severe recalcitrant nodular acne pediatric Patients, 12 to 15 Years]
Toxicity
Isotretinoin is teratogenic. It also causes mucocutaneous side effects suck as cheilitis, dry skin, and dry eyes.
Active Ingredient/Synonyms
(7e,9e,11e,13Z)-Retinoic acid | 13-cis-Retinoic acid | 13-cis-Vitamin a acid | 13-RA | cis-RA | Isotretinoina | Isotretinoine | Isotretinoino | Isotretinoinum | Neovitamin a acid | Isotretinoin |
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.