Product Information
Registration Status: ActiveSIN12179P
ELIDEL CREAM 1% W/W is approved to be sold in Singapore with effective from 2003-01-31. It is marketed by PHARMLINE MARKETING PTE LTD, with the registration number of SIN12179P.
This product contains Pimecrolimus 10mg in the form of CREAM. It is approved for TOPICAL use.
This product is manufactured by NOVARTIS PHARMA PRODUKTIONS GMBH in FRANCE, andMEDA Manufacturing 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.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Pimecrolimus is an immunomodulating agent used in the treatment of atopic dermatitis (eczema). It is currently available as a topical cream, once marketed by Novartis, (however Galderma will be promoting the molecule in Canada in early 2007) under the trade name Elidel.
Indication
For treatment of mild to moderate atopic dermatitis.
Mechanism of Action
Pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T cells. Also, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/lgE.
Pharmacokinetics
- Absorption
- Because of the low systemic absorption of pimecrolimus following topical application the calculation of standard pharmacokinetic measures such as AUC, Cmax, half-life, etc. cannot be reliably done.
- Distribution
- Metabolism
- No drug metabolism was observed in human skin in vitro. Oral administration yielded metabolites produced from O-demethylation and oxygenation reactions.
- Elimination
Toxicity
Side effects include burning sensation, irritation, pruritus, erythema, and skin infections, at the application site.
Active Ingredient/Synonyms
33-Epi-chloro-33-desoxyascomycin | Pimecrolimus | Pimecrolimusum | Pimecrolimus |
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.