País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUCONAZOLE
IMEKS PHARMA SDN. BHD.
FLUCONAZOLE
100Capsule Capsules; 50Capsule Capsules; 1Capsule Capsules
T.O. CHEMICALS (1979) LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ FLUNCO ® 200 CAPSULE Fluconazole (200 mg) _ _ 1 WHAT IS IN THE LEAFLET 1. What Flunco is used for 2. How Flunco works 3. Before you use Flunco 4. How to use Flunco 5. While you are using it 6. Side effects 7. Storage and Disposal of Flunco 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT FLUNCO IS USED FOR Fluconazole is classified as an antifungal medication. It is used to treat a wide range of fungal/yeast infections. You may be given Flunco under the following circumstances: • Internal infections caused by the fungus, _Cryptococcus_ – _cryptococcal_ meningitis, and infections at other sites i.e. skin and lungs. • Internal infections caused by the fungus, _Candida_ – it invades via the bloodstream to infect different organs including the visceral coverings of these organs. (lungs, intestine, heart, urinary tract) • Genital Candidiasis – fungal infection of the vagina or penis. • Prevention of infection in immunocompromised patient to curb infections. HOW FLUNCO WORKS Flunco is an antifungal agent that alters the cell membrane of fungus. This alteration inhibits the replicative effect of fungus in turn preventing the increase of fungal reproduction. BEFORE YOU USE FLUNCO_ _ _ _ - _When you must not use it_ Do not use Flunco if you: • have any allergic tendencies or in the past developed hypersensitive reactions to fluconazole or any of the ingredients stated in this leaflet. • are afflicted by any liver disease, or if you have an abnormal liver function test on your recent blood test. • have ever had severe skin reactions such as Steven-Johnson Syndrome and toxic epidermal necrolysis after treatment with any antibiotics. • are pregnant • are breast-feeding - _Before you start to use it _ Tell your doctor if you: • have any liver disease or if you have recently learnt that you had an abnormal liver blood profile • had any drug related allergies in the past - _Taking other medicines _ Info Llegiu el document complet
FLUNCO 200 Each capsule contains fluconazole 200mg. DESCRIPTION White powder filled in violet-white cap no. 0, bearing the letter “FLUNCO 200”. PROPERTIES Fluconazole is a triazole antifungal drug. It is a highly selective inhibitor of cytochrome P-450 dependent enzyme (14-alpha- desmethylase) resulting in impairment of ergosterol synthesis in fungal cell membranes. The subsequent loss of normal sterols correlates with the accumulation of 14 alpha-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole. Fluconazole is active against _Blastomyces dermatitides, Candida _ spp.,_ _ _Coccidioides _ _immitis, _ _Cryptococcus _ _neoformans, _ _Epidermophyton _ spp.,_ _ _Histoplasma _ _capsulatum, _ _Microsporum _ spp.,_ _and_ Trichophyton _spp. In common with other azole antifungal agents, most fungi show a higher apparent sensitivity to fluconazole _in vivo _than _in vitro._ Fluconazole is well-absorbed following oral administration and is not affected by concomitant food intake. The plasma levels or systemic bioavailability from oral route are over 90% of the level achieved from the intravenous route. Mean peak plasma concentrations of 6.72 µ g/ml have been reported in healthy subjects following a 400mg oral dose. Peak plasma concentrations (C max ) are reached within 1 to 2 hours of oral administration. Peak plasma concentrations and AUC’s increase proportionally to doses over a range of 50 to 400mg. Multiple dosing lead to increases in peak plasma concentrations. Steady state concentrations are reached in 6 to 10 days but it may be attained on day 2 if a loading dose of twice the usual daily dose is given on day 1. Fluconazole is widely distributed and the apparent volume of distribution is close to that of total body water. Concentration in breast milk, joint fluid, saliva, sputum, vaginal fluids and peritoneal fluid are similar to those achieved in plasma. However, concentrations in the cerebrospinal fluid range from 50 to 90% of plasma concentrations, even in the absence Llegiu el document complet