Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GRISEOFULVIN
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
GRISEOFULVIN
0 1000 Tablet Tablets; 100 Tablet Tablets; 0 500 Tablet Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
KRISOVIN TABLET Griseofulvin (500mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Krivosin is used for 2. How Krivosin works 3. Before you use Krivosin 4. How to use Krivosin 5. While you are using it 6. Side effects 7. Storage and disposal of Krivosin 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT KRIVOSIN IS USED FOR Krivosin contains the antifungal griseofulvin. Krivosin is used to treat tinea, a fungal infection. It is only used when other antifungal treatments, such as tinea creams or powders, have not worked. Krivosin will not work for bacterial or viral infections. HOW KRIVOSIN WORKS Tinea may occur in the skin of the body, scalp, hair or nails. Krivosin 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. That is why it is important to continue treatment until all the old infected tissue is gone. Ask your doctor or pharmacist if you have any questions about why Krivosin has been prescribed for you. BEFORE YOU USE KRIVOSIN - _When you must not use it _ Before taking Krivosin, you must tell your doctor if you: • have ever had an allergic reaction to any of the ingredients listed at the end of this leaflet • are or may become pregnant • are breast-feeding • planning to father a child • have any other health problems, especially liver disease and lupus (systemic lupus erythematosis). Krivosin may reduce the effectiveness of oral contraceptives. You are advised to use an alternate or additional method of contraception while taking griseofulvin concurrently with estrogen-containing oral contraceptives and for 1 month after stopping griseofulvin. This medicine may cause birth defects. It must not be used during pregnancy. If you intend to become pregnant, you should delay pregnancy until one month after stopping treatment. Krivosin may cause abnormalities in sperm cells. Men should not father children until at least si Baca dokumen lengkap
DESCRIPTION KRISOVIN KRISOVIN PHARMACOKINETICS INDICATIONS DOSAGE PHARMACODYNAMICS CONTRAINDICATIONS DRUG INTERACTIONS PRECAUTIONS A 12 mm diameter, round, convex, scored marked “UP 500” white tablet. Each tablet contains Griseofulvin 500mg. Griseofulvin is administered by mouth in the treatment of infections caused by various species of Epidermophyton, Microsporum, and Trichophyton. It is generally given for such infections that involve the scalp, hair, nails and skin and which do not respond to topical treatment such as Tinea barbae, Tinea capitis, Tinea corporis, Tinea cruris, Tinea pedis and Tinea unguium. Infections of the soles of the feet, the palms of the hands and the toenails respond slowly. Griseofulvin is a fungistatic antibiotic which inhibits fungal cell mitosis by causing disruption of the mitotic spindle structure, thereby arresting the metaphase of cell division. It may also interfere with DNA production. It is deposited in varying concentrations in the keratin precursor cells of skin, hair, and nails, rendering the keratin resistant to fungal invasion. As the keratin is shed, it is replaced with healthy tissue. Absorption of griseofulvin from the gastro-intestinal tract is variable a n d incomplete, but is enhanced by reducing the particle size and by administration with a fatty meal. Absorption of micronised griseofulvin, as in Krisovin Tablet, ranges from 25%-70% after an oral dose. Peak serum concentrations occur approximately 4 hours following administration of a single dose of 500 mg of micronised griseofulvin. It is deposited in varying concentrations in the keratin precursor cells and is concentrated in the stratum corneum of the skin, nails and hair, thus preventing fungal invasion of newly formed cells. It can be detected in the stratum corneum of the skin within a few hours following administration. Concentrations of 12-25 mcg/g are maintained in skin during long-term administration, while concurrent plasma concentrations remain at about 1-2 mcg/mL. Only a very small fraction of an Baca dokumen lengkap