Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
MICROCIDAL®-125 TABLETS MICROCIDAL®-500 TABLETS SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): MICROCIDAL ® -125 TABLETS MICROCIDAL ® -500 TABLETS COMPOSITION: Each tablet contains 125 mg or 500 mg of griseofulvin . PHARMACOLOGICAL CLASSIFICATION: A 20.1.7 Antifungal antibiotics. PHARMACOLOGICAL ACTION: Griseofulvin is fungistatic in vitro for various species of the dermatophytes Microsporum, Epidermophyton and Trichophyton. The drug has no effect on bacteria or on other fungi. A prominent morphologic manifestation of the action of griseofulvin is the production of multinucleate cells as the drug inhibits fungal mitosis. Griseofulvin causes disruption of the mitotic spindle by interacting with polymerized microtubules. Although the effects of the drug are thus similar to those of colchicine and the vinca alkaloids, its binding sites on the microtubular protein are distinct. There is evidence that griseofulvin binds to a microtubule-associated protein in addition to its binding to tubulin. Although failure of ringworm lesions to improve is not rare, isolates from these patients usually are still susceptible to griseofulvin in vitro. The oral administration of a 0,5 g to 1 g dose of griseofulvin produces peak plasma concentrations of approximately 1 microgram/mL in about 4 hours. Blood levels are quite variable. Griseofulvin has a half-life in plasma of about 1 day, and approximately 50% of the oral dose can be detected in the urine within 5 days, mostly in the form of metabolites. The primary metabolite is 6-methylgriseofulvin. Barbiturates decrease the absorption of griseofulvin from the gastrointestinal tract. The drug is deposited in keratin precursor cells. The antibiotic present in such cells when they differentiate is tightly bound to, and persists in, keratin and Read the complete document