Gris-peg (griseofulvin Ultramicrosize) Tablets, Usp

C17H17ClO 6 M.W. 352.77 Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each Gris-PEG tablet contains: Active Ingredient: griseofulvin ultramicrosize................................................. 125 mg Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, and titanium dioxide. OR Active Ingredient: griseofulvin ultramicrosize.............................................. 250 mg Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, sodium lauryl sulfate, and titanium dioxide. CLINICAL PHARMACOLOGY Microbiology – Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton and Trichophyton. It has no effect on bacteria or other genera of fungi. Pharmacokinetics – 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.