in is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, north american blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.

aller particle sizes result in an enhanced effect. lower oral dosage levels have not been tested. subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice. thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving griseofulvin at levels of 2%, 1% and 0.2% of the diet, and in female rats receiving the two higher dose levels. although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusion in this regard. in subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species. disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals. griseofulvin has been reported to have a colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals. usage in pregnancy see contraindications section. animal reproduction studies it has been reported in the literature that griseofulvin was found to be embryotoxic and teratogenic on oral administration to pregnant rats. pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin. suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.

nfection. ultramicrosize griseofulvin tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing. adults: daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. for those fungal infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended. pediatric use: approximately 7.3 mg per kg of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. on this basis, the following dosage schedule is suggested: 16 to 27 kg: 125 mg to 187.5 mg daily. over 27 kg: 187.5 mg to 375 mg daily children and infants 2 years of age and younger – dosage has not been established. clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective. clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

adverse reactions, contact sandoz inc., at 1-800-525-8747 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

ofulvin tablets were found to be bioequivalent to the physically altered (crushed) 250 mg ultramicro-crystalline griseofulvin tablets (see table 1 ). table 1: mean (± sd) of the pharmacokinetic parameters for griseofulvin administered in applesauce as a single dose of ultramicrosize griseofulvin tablets 250 mg uncrushed and crushed to fasted healthy volunteers (n=24) 250 mg ultramicrocrystalline griseofulvin tablets unaltered 250 mg ultramicrocrystalline griseofulvin tablets physically altered (crushed and in applesauce) c max (ng/ml) 600.61 (± 167.6) 672.61 (± 146.2) t max (hr) 4.04 (± 2.2) 3.08 (± 1.02) auc (ng·hr/ml) 8618.89 (± 1907.2) 9023.71 (± 1911.5)