Periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done.Since Griseofulvin is derived from species of penicillin, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty.Lupus erythematosus, lupus-like syndromes or exacerbation of existing lupus erythematosus have been reported in patients receiving Griseofulvin.Since a photosensitivity reaction is occasionally associated with Griseofulvin therapy, patients should be warned to avoid exposure to intense or prolonged natural or artificial sunlight.Griseofulvin has been reported in the literature to interfere with the metabolism of various compounds. Safety in pediatric patients older than 2 years of age at dosages greater than 10 mg/kg daily has not been established.There have been postmarketing reports of severe skin and hepatic adverse events associated with Griseofulvin use (see When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes, urticaria, and rarely, angioneurotic edema, and erythema multiforme. Griseofulvin has been available since 1958 to treat ringworm (tinea).
Teratogenicity was also seen in mice when Griseofulvin was administered in doses equivalent to 5 g/kg/day [40X the MRHD based on BSA] for 2 consecutive days at various stages of the pregnancy.Safety and efficacy of Griseofulvin for prophylaxis of fungal infections have not been established.Severe skin reactions (e.g. This site uses cookies. However, it may cause drowsiness, confusion dizziness, and impaired co-ordination, see section 4.8. The majority of the dose, as 6-desmethylgriseofulvin or the glucuronide conjugate, and other metabolites is excreted in the urine, with less than 1% administered dose beinge excreted as unchanged griseofulvin.

Sweat and transdermal fluid loss appear to play an important role in griseofulvin transfer in the stratum corneum. If the seal has been broken or is removed, Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Griseofulvin USP (microsize) in a pink to orange colored,This product is protected by a tamper-resistant sealaround the neck opening.

When the drug is discontinued, Griseofulvin concentrations in the skin decline less rapidly than those in plasma.Griseofulvin is metabolized by the liver to 6-desmethylGriseofulvin and its glucuronide conjugate.Griseofulvin has a variable elimination half-life in plasma (9 to 24 hours). Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis.

Oral griseofulvin Dosing schedule. Therefore, an alternate or second form of birth control may be indicated during periods of concurrent use (see also Cyclosporine levels may be reduced when administered concomitantly with Griseofulvin, resulting in a decrease in the pharmacologic effects of cyclosporine.Serum salicylate concentrations may be decreased when Griseofulvin is given concomitantly with salicylates.Barbiturates usually depress Griseofulvin activity by decreasing plasma levels and concomitant administration may require a dosage adjustment of the antifungal agent.Nausea, vomiting, flushing, tachycardia, and severe hypotension have been reported following alcohol ingestion during Griseofulvin therapy.In subacute toxicity studies, orally administered Griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species.

Patients should be cautioned to avoid consumption of alcoholic beverages, and medicines containing alcohol, while undergoing griseofulvin therapy.In patients undergoing long term griseofulvin therapy, i.e for tinea unguium, consideration should be given to periodic monitoring of blood chemistry, particularly for patients with pre-existing blood disorders, since griseofulvin may cause blood disorders, see section 4.8.In common with any antibiotic, therapy with griseofulvin may result in the overgrowth of non-susceptible organisms, i.e bacteria or yeasts, or non-dermatophyte fungi, that are often cofactors in tinea infections, especially tinea pedis. Griseofulvin may depress plasma levels, and therefore the efficacy, of concommitantly administered medicinal products that are metabolised by cytochrome P450 3A4. The peak serum level in fasting adults given 0.5 g of Griseofulvin microsize occurs at about four hours and ranges between 0.5 to 2 mcg/mL.


Administration of activated charcoal may also be of use. The remainder of the dose, principally as metabolites, is excreted in bile and faeces.Griseofulvin can induce aneuploidy and meiotic delay in mouse oocytes following oral administration of high doses, i.e. The dose should not be less than 10 mg / Kg bodyweight / day.