País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Pimecrolimus
Meda Pharmaceuticals Pty Ltd
Medicine Registered
ELIDEL(120507)ACI 1 ELIDEL ® _pimecrolimus _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Elidel cream. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks to you or your child of using Elidel cream against the benefits they expect it will provide. This leaflet has mostly been written for patients who are using Elidel on themselves, but, as Elidel can be used in children as young as 3 months, the same advice and precautions need to be exercised when parents and carers are using Elidel on children who have been prescribed the product. There are additional instructions when using Elidel in infants up to 2 years and these are explained separately in the leaflet. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ELIDEL CREAM IS USED FOR Elidel cream is used to treat the early signs and symptoms of eczema (also called atopic dermatitis), such as itching, redness and tiny bumps or thickening of the skin. It is suitable for infants of 3 months or older, children, teenagers and adults. Elidel can be used to treat rep Llegiu el document complet
1 ELIDEL(120507)API ELIDEL (PIMECROLIMUS) NAME OF THE DRUG The active ingredient of Elidel is pimecrolimus. Chemical name: (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2- {(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25- dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene- 2,3,10,16-tetraone Chemical structure: O O O OH O N O O O O OH O Cl H H DESCRIPTION Elidel (pimecrolimus) cream 1% contains the compound pimecrolimus, the 33-epi-chloro- derivative of the macrolactam ascomycin. Pimecrolimus is a white to off-white fine crystalline powder. It is very soluble in methanol and ethanol and practically insoluble in water. Each gram of Elidel cream 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, medium chain triglycerides and water. Molecular formula: C 43 H 68 ClNO 11 Relative molecular mass: 810.47 CAS number: 137071-32-0 2 ELIDEL(120507)API PHARMACOLOGY PHARMACODYNAMICS The actual mechanism of action of pimecrolimus in atopic dermatitis is not known. Pimecrolimus is an ascomycin macrolactam derivative. In vitro studies showed that pimecrolimus binds with high affinity to macrophilin-12 and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T-cell proliferation and prevents the transcription and release of both T helper type 1 cell (TH1) and T helper type 2 cell (TH2) inflammatory cytokines such as interleukin-2, interferon-γ, interleukin-4, interleukin-5, interleukin-10, tumour necrosis factor alpha and granulocyte macrophage colony-stimulati Llegiu el document complet