SPL Set ID: 265a20de-8e20-4fc4-b4a3-e3738e5820b3

FULVICIN P/G Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium . Griseofulvin crystals are partly dissolved in polyethylene glycol 8000 and partly dispersed throughout the label matrix. Each FULVICIN P/G Tablet contains 165 mg ultramicrosize griseofulvin, USP. The inactive ingredients for FULVICIN P/G 165 Tablets include: corn starch, lactose anhydrous, magnesium stearate, polyethylene glycol 8000, and sodium lauryl sulfate. ACTIONS Microbiology Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton , and Trichophyton . It has no effect on bacteria or on other genera of fungi. Human Pharmacology Following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. The efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin. This factor permits the oral intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. However, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy.