pharmacopeia
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/api/v1/drug/griseofulvin

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Tubulin Interactions.

Indications

Sourced from openFDA
  • INDICASTIONS AND USAGE Griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea barbae Tinea capitis Tinea unguium when caused by one or more of the following species of fungi: Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.ICD-10: B35.3

Contraindications

Sourced from openFDA
  • Griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Griseofulvin may cause fetal harm when administered to a pregnant woman.contraindicated

Dosage & administration

Sourced from openFDA

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium – depending on rate of growth – fingernails, at least 4 months; toenails, at least 6 months. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of tinea pedis, yeasts and bacteria may be involved as well as dermatophytes. Griseofulvin tablets, USP will not eradicate hese associated bacterial or yeast infections. ADULTS : 0.5 g daily (125 mg q.i.d., 250 mg b.i.d., or 500 mg/day). Patients with less severe or 300 extensive infections may require less, whereas those with widespread lesions may require a starting dose of 0.75 g to 1 g/day. This may be reduced gradually to 0.5 g or less after a response has been noted. In all cases, the dosage should be individualized. PEDIATRIC PATIENTS (older than 2 years): A dosage of 10 mg/kg daily is usually adequate (pediatric patients from 30 to 50 lb, 125 mg to 250 mg daily; pediatric patients over 50 lb, 250 mg to 500 mg daily, in divided doses).

Warnings & precautions

Sourced from openFDA

Prophylactic Usage Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established. Serious Skin Reactions Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section). Hepatotoxicity Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use. These reactions may be serious and may result in hospitalization or death. Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted (see ADVERSE REACTIONS section).

Adverse reactions

Sourced from openFDA

There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section). When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes, urticaria, and rarely, angioneurotic edema, and erythema multiforme. These may necessitate withdrawal of therapy and appropriate countermeasures. Peripheral neuropathy and paresthesias of the hands and feet have been reported and may be related to treatment duration. Most patients treated with griseofulvin for less than six months experienced improvement or resolution of their neuropathy upon withdrawal of the griseofulvin. Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion and impairment of performance of routine activities. Proteinuria, nephrosis (sometimes associated with existing systemic lupus erythematosus), leukopenia, coagulopathy, hepatitis, elevated liver enzymes, hyperbilirubinemia, and GI bleeding have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc., at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Pregnancy Category X See CONTRAINDICATIONS and PRECAUTIONS, Drug Interactions .

Overdosage

Sourced from openFDA

There is limited experience on overdose with griseofulvin. In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required.

Approval history

Sourced from openFDA
  • Sep 9, 1971ANDAANDA060569Chartwell Rx
  • Apr 6, 1982ANDAANDA061996Chartwell Rx
  • Mar 2, 2005ANDAANDA065200Chartwell Rx
  • Jul 6, 2007ANDAANDA065394Actavis Mid Atlantic
  • Oct 8, 2010ANDAANDA065438Cosette
  • Oct 22, 2012ANDAANDA202482Sigmapharm Labs Llc
  • Oct 22, 2012ANDAANDA202545Sigmapharm Labs Llc
  • Aug 7, 2013ANDAANDA091592Sandoz

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
285 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3914%
  2. 2Headache155.3%
  3. 3Off Label Use134.6%
  4. 4Rash124.2%
  5. 5Pyrexia113.9%
  6. 6Diarrhoea103.5%
  7. 7Drug Hypersensitivity103.5%
  8. 8Pathogen Resistance103.5%
  9. 9Drug Reaction With Eosinophilia And Systemic Symptoms93.2%
  10. 10Drug Resistance93.2%
  11. 11Pain93.2%
  12. 12Stevens-johnson Syndrome93.2%
  13. 13Delirium82.8%
  14. 14Dizziness82.8%
  15. 15Drug Interaction82.8%

Literature

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Recent PubMed references pinned to Griseofulvin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Griseofulvin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Griseofulvin work?
Mechanism-of-action class: Tubulin Interactions.
What is Griseofulvin used for?
According to FDA labeling, Griseofulvin carries indications including: INDICASTIONS AND USAGE Griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea barbae Tinea capitis Tinea unguium when caused by one or more of the following species of fungi: Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Griseofulvin?
Griseofulvin is classified as Antibiotics, Antifungals for systemic use, Tubulin Inhibiting Agent, Tubulin Interactions, Cellular Growth Phase Arrest, Decreased DNA Replication, Decreased Mitosis, Microtubule Inhibition.
What are the brand names for Griseofulvin?
Griseofulvin is marketed under brand names including Fulvicin P/G, Gris-PEG.
What are the contraindications for Griseofulvin?
Griseofulvin labeling lists contraindications including: Griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Griseofulvin may cause fetal harm when administered to a pregnant woman.. Always consult the full prescribing information and a clinician.
Note. Data for griseofulvin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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