Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOCONAZOLE
HOVID BERHAD
KETOCONAZOLE
30 Tablet Tablets; 100 Tablet Tablets
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ HOVID-KETOCONAZOLE 200MG TABLET _® _ Ketoconazole (200 mg) Page no.1 WHAT IS IN THIS LEAFLET 1. What _hovid-Ketoconazole 200mg _ _Tablet_ is used for 2. How _hovid-Ketoconazole 200mg _ _Tablet_ works 3. Before you use _hovid-_ _Ketoconazole 200mg Tablet _ 4. How to use _hovid-Ketoconazole _ _200mg Tablet_ 5. While you are using _hovid-_ _Ketoconazole 200mg Tablet_ 6. Side effects _7._ Storage and Disposal of _hovid-_ _Ketoconazole 200mg Tablet _ 8. Product Description 9. Manufacturer 10._ _Product Registration Holder 11. Date of revision 12. Serial Number WHAT _HOVID-KETOCONAZOLE 200MG _ _TABLET _IS USED FOR Ketoconazole_ _should be used only when other effective antifungal therapy is not available. It is used for the treatment of systemic fungal infections (e.g. blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis). Ketoconazole should not be used for fungal meningitis because it does not penetrate well into the central nervous system (CNS). HOW _HOVID-KETOCONAZOLE 200MG _ _TABLET_ WORKS Ketoconazole is an antifungal agent which will disrupt production of fungal cell membrane components, therefore damaging and changing its permeability. This results in loss of essential cell elements and buildup of toxicity in fungal cells and will lead to the death of fungal cells. Ketoconazole works effectively against Candida albicans. BEFORE YOU USE _HOVID-KETOCONAZOLE _ _200MG TABLET_ _-When you must not use it _ In patients with acute porphyria, acute or chronic liver disease, or allergic to other azole antifungals (itraconazole, fluconazole, miconazole). Ketoconazole should not be taken together with terfenadine, astemizole and cisapride. Ketoconazole is not recommended during pregnancy. Nursing mothers should stop breast-feeding when beginning and throughout treatment with ketoconazole for 24 to 48 hour thereafter as it is excreted in breast milk and may increase the possibility of kernicterus in the nursing infant. Ketoconazole s Aqra d-dokument sħiħ
DESCRIPTION Round, white uncoated tablet, bevel-edged, shallow convex faces, “HD” and break-bar embossed on one face. COMPOSITION Each tablet contains: Ketoconazole 200 mg/tablet. PHARMACODYNAMICS Fungistatic; may be fungicidal, depending on concentration; inhibits biosynthesis of ergosterol or other sterols, damaging the fungal cell membrane and altering its permeability; as a result, loss of essential intracellular elements may occur; also inhibits biosynthesis of triglycerides and phospholipids by fungi; in addition, inhibits oxidative and peroxidative enzyme activity, resulting in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis. In Candida albicans, inhibits transformation of blastospores into invasive mycelial form. PHARMACOKINETICS Readily absorbed orally in normal patients and it is excreted as metabolites and unchanged drug chiefly in the faeces; some is excreted in the urine. INDICATIONS • hovid-Ketoconazole 200 Tablet should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweight the potential risks. • hovid-Ketoconazole 200 Tablet are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. • hovid-Ketoconazole 200 Tablet should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. CONTRAINDICATIONS • It is contraindicated in patients with acute or chronic liver disease or with a known hypersensitivity to the drug. • It is also contraindicated when co-administered with terfenadine, astemizole and cisapride. WARNING AND PRECAUTIONS • Ketoconazole was considered to be unsafe in patients with acute porphyria because it has been shown to be porphyrinogenic in animals or in vitro systems. • Aqra d-dokument sħiħ