Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GRISEOFULVIN
ZONTRON PHARMACEUTICALS SDN. BHD.
GRISEOFULVIN
100 Tablets
TERAPUTICS SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FULVICIDE TABLET Griseofulvin (500 mg) __________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Fulvicide Tablet is used for 2. How Fulvicide Tablet works 3. Before you use Fulvicide Tablet 4. How to use Fulvicide Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Fulvicide Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FULVICIDE TABLET IS USED FOR Fulvicide tablet is used to treat a fungal infections. HOW FULVICIDE TABLET WORKS Fungal infection may occur in the skin of the body, scalp, hair or nails. Griseofulvin works by helping newly formed skin, hair and nails to resist attack by fungi. As the new tissue (keratin) grows, the old infected keratin is cast off. BEFORE YOU USE FULVICIDE TABLET _- When you must not use it _ Do not take this medicine if: you are allergic to griseofulvin or any other ingredients of this medicine (listed in Product Description) _ _ _- Before you start to use it _ Tell your doctor if:_ _ you have liver impairment porphyria (Constipation or diarrhea) you had problem after taking certain medicines eg penicilins (antibiotics) _Pregnancy and lactation _ Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast- feeding before using any medicine. Fulvicide Tablet is not recommended for use in pregnancy. _- Taking other medicines _ Tell your doctor if you are using: Coumarin anticoagulants Barbiturates such as Primidone (antifungal effects) Phenobarbitone (to relieve anxiety) Doxercalciferol (to help maintain healthy levels of chronic kidney disease) Phenylbutazone (treating fever, pain, and inflammation in the body) Other sedative and hypnotic drugs (sleep disorder) that induce metabolising enzymes. Oral contraceptives Tell your doctor if you are taking any other medicines, including any that you Baca dokumen lengkap
PRODUCT LITERATURE FULVICIDE TABLET 500 MG Each tablet contains: Griseofulvin 500 mg DESCRIPTION White coloured double scored round odourless tablet with T embossed on one side. PHARMACODYNAMICS Pharmacotherapeutic group: Antifungals for systemic use. Griseofulvin is an antifungal antibiotic that is active in vivo against common dermatophytes. The antifungal effect is manifested by binding to tubulin, at distinct binding sites, thus interferring with the microtubule function and causing inhibition of mitosis, and arresting cell division. The inhibition of fungal mitosis leads to the production of multinucleate cells of characteristic morphology. On entering the systemic circulation, griseofulvin binds to keratin in keratin precursor cells, thereby making them resistant to fungal infections. The drug only reaches the site of action when hair or skin is replaced by the keratin-griseofulvin complex. Griseofulvin then enters the dermatophyte through energy dependent transport processes and binds to the fungal microtubules, interferring with, and inhibiting mitosis, and the deposition of fungal cell walls. Mycology: Griseofulvin has antifungal activity against the following dermatophytes, although there is species and strain variability in susceptibility. _Trichophyton rubrum, T. tonsurans, T. mentagrophytes, T. interdigitalis, T. verrucosum, _ _T. megnini, T. gallinae,T. Crateriform, T. sulphureum and T. schoenleinii. Microsporum _ _audouinii, M. Canis, M. gypseum. Epidermophyton floccosum. _ Griseofulvin has no activity against dermatophyte fungi of other genera, non- dermatophyte fungi, yeasts, gram positive bacteria, or gram negative bacteria. If any of these are cofactors in the pathology of infection, suitable additional therapy will be required for their eradication. PHARMACOKINETICS Absorption: The absorption of griseofulvin from the gastrointestinal tract is varaible and incomplete. On average, less than 50% of the oral dose is absorbed, but administration after a fatty meal and a reduction in particle size w Baca dokumen lengkap