Indications And Clinical Uses: Orally effective against superficial infections caused by those fungi responsible for dermatomycoses in man and animals, namely: M. canis, M. gypseum, M. audouini, E. floccosum, T. tonsurans, T. rubrum, T. mentagrophytes, T. megninii, T. gallinae, T. verrucosum, T. sulfureum, T. interdigitale, T. schoenleinii, T. crateriform. Griseofulvin is inactive against: C. albicans (monilia), C. neoformans, B. dermatitidis, A. israelii, H. capsulatum, C. immitis, M. furfur (tinea versicolor) and bacteria. The drug is useful in the treatment of fungal infections of the scalp and those of the glabrous skin. The drug is less effective in chronic infections of the feet, palms, and nails. Since these chronic fungal infections tend to cause hyperkeratosis, concomitant topical keratolytic therapy is almost always necessary.
Manufacturers’ Warnings In Clinical States: Alcoholic beverages should be forbidden during treatment with Fulvicin U/F since griseofulvin may augment or potentiate the effects of alcohol which may lead to tachycardia and flush and can be the cause of more serious consequences.
Precautions: As with all antibiotics, the use of this drug may result in an overgrowth of nonsusceptible organisms, particularly monilia. Periodic blood cell counts should be done during griseofulvin therapy, and its administration should be discontinued if granulocytopenia occurs. Albuminuria and hyaline casts have been associated with the use of griseofulvin, but renal function tests have revealed no impairment. The urine of patients on prolonged therapy should be examined for porphobilinogen. Since griseofulvin is derived from a species of penicillin, the possibility of cross sensitivity with penicillin exists, however known penicillin sensitive patients have been treated without difficulty.
Concomitant administration of phenobarbital and griseofulvin may result in reduced blood levels of griseofulvin due to the enzymatic acceleration of griseofulvin metabolism. During therapy with griseofulvin, patients should be advised to avoid exposure to intense natural or artificial sunlight.
Dosage: Dosage must be individualized. Adults: 500 mg daily (125 mg 4 times a day or 250 mg twice daily). Children: A dosage of 10 mg/kg is usually adequate (children from 14 to 23 kg, 125 to 250 mg daily; children over 23 kg, 250 to 500 mg, in divided doses). Patients with less severe infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 to 1 g per day.
Availability And Storage: Each white, scored tablet contains: ultra fine griseofulvin USP 250 mg or 500 mg. Nonmedicinal ingredients: 250 mg: cornstarch, magnesium stearate and polysorbate 80. 500 mg: colloidal silicon dioxide, cornstarch, magnesium stearate and pluronic F-68. Tartrazine-free. Bottles of 100.