Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOCONAZOLE
ABIOTIDE SDN. BHD.
KETOCONAZOLE
15 gm
HOVID BERHAD
AETOS KETOCONAZOLE CREAM 2% W/W Ketoconazole (2% w/w) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Aetos Ketoconazole Cream 2% w/w is used for 2. How Aetos Ketoconazole Cream 2% w/w works 3. Before you use Aetos Ketoconazole Cream 2% w/w 4. How to use Aetos Ketoconazole Cream 2% w/w 5. While you are using it 6. Side effects 7. Storage and Disposal of Aetos Ketoconazole Cream 2% w/w 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT AETOS KETOCONAZOLE CREAM 2% W/W IS USED FOR Aetos Ketoconazole Cream 2% w/w is a medicine for treating skin infections caused by fungi or yeasts. It is used for treating skin infections on the trunk, groin, feet or hands. Aetos Ketoconazole Cream 2% w/w is also used to treat skin infections that usually occur on the face and on the chest with reddish brown patches and yellow or white scaling (seborrheic dermatitis). HOW AETOS KETOCONAZOLE CREAM 2% W/W WORKS Aetos Ketoconazolde Cream 2% w/w works by killing the fungus that causes the infection. BEFORE YOU USE AETOS KETOCONAZOLE CREAM 2% W/W - _When you must not use it _ Do not use Aetos Ketoconazole Cream 2% w/w if you know you are hypersensitive (allergic) to it. Symptoms of hypersentivity include itching and red skin which may occur after you have applied Aetos Ketoconazole Cream 2% w/w. _ _ - _Before you start to use it _ Talk to your doctor or pharmacist before using this medicine: • If you have recently used a cream, ointment or lotion on your skin infection that contains a steroid: You should continue to apply a mild steroid (such as hydrocortisone) cream, ointment or lotion in the morning whilst applying Aetos Ketoconazole Cream 2% w/w in the evening. The mild steroid treatment can then be gradually stopped over a period of 2 – 3 weeks. If you have questions about stopping your steroid cream, ointment or lotion, ask your doctor or pharmacist. _Pregnancy and lactation _ There are no known risks with the use of Aetos Ketoconaz Läs hela dokumentet
DESCRIPTION White to off white, opaque cream. COMPOSITION Ketoconazole 2% w/w. PHARMACODYNAMICS PHARMACODYANMIC PROPERTIES Pharmacotherapeutic group: Antifungals for Topical Use, Imidzole and triazole derivatives, ATC code: D01AC08. MECHANISM OF ACTION: Ketoconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane. PHARMACODYNAMIC EFFECTS Usually ketoconazole cream acts rapidly on pruritus, which is commonly seen in dermatophyte and yeast infections, as well as skin conditions associated with the presence of _ Malassezia spp._ This symptomatic improvement is observed before the first signs of healing are observed. MICROBIOLOGY Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent antimycotic activity against dermatophytes such as _Trichophyton spp., Epidermophyton floccosum_ and _ Microsporum _ _spp._ and against yeasts, including _ Malassezia spp._ and _ Candida _ _spp._ especially the effect on _Malassezia spp._ is very pronounced. PHARMACOKINETICS Plasma concentrations of ketoconazole were not detectable after topical administration of Aetos Ketoconazole Cream 2% w/w in adults on the skin. INDICATIONS Aetos Ketoconazole Cream 2% w/w is indicated for topical application in the treatment of dermatophyte infections of the skin: tinea corporis, tinea cruris, tinea manus and tinea pedis due to _Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum _ _canis _and_ Epidermophyton floccosum,_ as well as in the treatment of cutaneous candidosis and tinea (pityriasis) versicolor. Aetos Ketoconazole Cream 2% w/w is also indicated for the treatment of seborrheic dermatitis, a skin condition associated with the presence of _Malassezia furfur._ CONTRAINDICATIONS Aetos Ketoconazole Cream is contraindicated in individuals who have shown hypersensitivity to ketoconazole and any of its ingredients. WARNINGS AND PRECAUTIONS Aetos Ketoconazole Cream 2% w/w is not for ophthalmic use. If coadministered with a topical corticosteroid, to pre Läs hela dokumentet