A PEDiNOL Product

Indications and Usage

Gris-PEG (griseofulvin ultramicrosize) is indicated for the treatment of the following ringworm infections:

  • tinea corporis (ringworm of the body)
  • tinea pedis (athlete’s foot)
  • tinea cruris (ringworm of the groin and thigh)
  • tinea barbae (barber’s itch)
  • tinea capitis (ringworm of the scalp)
  • tinea unguium (onychomycosis, ringworm of the nails)

When caused by one or more of the following genera of fungi:

  • Trichophyton rubrum
  • Trichophyton tonsurans
  • Trichophyton mentagrophytes
  • Trichophyton interdigitalis
  • Trichophyton verrucosum
  • Trichophyton megnini
  • Trichophyton gallinae
  • Trichophyton crateriform
  • Trichophyton sulphureum
  • Trichophyton schoenleini
  • Microsporum audouini
  • Microsporum canis
  • Microsporum gypseum
  • Epidermophyton floccosum

NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following:

  • bacterial infections
  • candidiasis (moniliasis)
  • histoplasmosis
  • actinomycosis
  • sporotrichosis
  • chromoblastomycosis
  • coccidioidomycosis
  • North American blastomycosis
  • cryptococcosis (torulosis)
  • tinea versicolor
  • nocardiosis

Important Safety Information

Gris-PEG is contraindicated in patients with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin. Griseofulvin should not be prescribed to pregnant patients. Two cases of conjoined twins have been reported since 1977 in patients taking griseofulvin during the first trimester of pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use. When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, uticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. (See WARNINGS section of full Prescribing Information).

For more information on Gris-PEG, please see the full Prescribing Information.