Griseofulvin

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# Overview
Griseofulvin is a antifungal that is FDA approved for the {{{indicationType}}} of ringworm infections.   Common adverse reactions include skin rashes, urticaria, erythema multiform-like drug reactions, and angioneurotic edema.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- 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), and 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 and 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 and nocardiosis.
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Griseofulvin in adult patients.

### NonGuideline-Supported Use
- Dosing Information
- Griseofulvin 500 mg daily for 2 to 4 weeks.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- 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), and 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 and 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 and nocardiosis.
- Approximately 3.3 mg per pound 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: Children weighing 35-60 pounds - 125 mg to 187.5 mg daily. Pediatric patients weighing over 60 pounds - 187.5 mg to 375 mg daily. Children and infants 2 years of age and younger - dosage has not been established.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Griseofulvin in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Griseofulvin in pediatric patients.

# Contraindications
- Two cases of conjoined twins have been reported since 1977 in patients taking griseofulvin during the first trimester of pregnancy. Griseofulvin should not be prescribed to pregnant patients. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
- This drug is contraindicated in patients with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin.

# Warnings
- 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.
- 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.
- Animal Toxicology
- Chronic feeding of griseofulvin, at levels ranging from 0.5%-2.5% of the diet resulted in the development of liver tumors in several strains of mice, particularly in males. Smaller 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 2.0%, 1.0% 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.

### Precautions
- Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done. Since griseofulvin is derived from species of Penicillium, the possibility of cross-sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty. Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Occasionally slight abnormalities in liver enzymes (irrespective of drug relationship) were reported with an incidence of less than 1%, specifically elevated ALT and/orAST. The majority of subjects with elevated liver enzymes also had concomitant medical conditions and were taking other drugs that may have increased the propensity for elevated values. When follow-up was provided, changes in elevated liver enzymes appeared to be reversible. Lupus erythematosus or lupus-like syndromes have been reported in patients receiving griseofulvin. Griseofulvin decreases the activity of warfarin-type anticoagulants so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after griseofulvin therapy. Barbiturates usually depress griseofulvin activity and concomitant administration may require a dosage adjustment of the antifungal agent. There have been reports in the literature of possible interactions between griseofulvin and oral contraceptives. The effect of alcohol may be potentiated by griseofulvin, producing such effects as tachycardia and flush.

# Adverse Reactions

## Clinical Trials Experience
- 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, erythema multiform-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesia of the hands and feet have been reported after extended therapy. 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 and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs. When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Griseofulvin in the drug label.

# Drug Interactions
There is limited information regarding Griseofulvin Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Griseofulvin in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Griseofulvin during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Griseofulvin with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Griseofulvin with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Griseofulvin with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Griseofulvin with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Griseofulvin with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Griseofulvin in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Griseofulvin in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Griseofulvin in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Griseofulvin in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Griseofulvin in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Griseofulvin in the drug label.

# Overdosage

## Chronic Overdose
There is limited information regarding Chronic Overdose of Griseofulvin in the drug label.

# Pharmacology

## Mechanism of Action
- Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton and Trichophyton. It has no effect on bacteria or other genera of fungi.

## Structure
- Gris-PEG Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium.
- Each Gris-PEG tablet contains:
- Active Ingredient: griseofulvin ultramicrosize .... 125 mg
- Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, and titanium dioxide.
- or
- Active Ingredient: griseofulvin ultramicrosize .... 250 mg
- Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, sodium lauryl sulfate, and titanium dioxide.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Griseofulvin in the drug label.

## Pharmacokinetics
- Following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions.
- The efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin. This factor permits the oral intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. However, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy.
- In a bioequivalence study conducted in healthy volunteers (N=24) in the fasted state, 250 mg ultramicrocrystalline griseofulvin tablets were compared with 250 mg ultramicrocrystalline griseofulvin tablets that were physically altered (crushed) and administered with applesauce. The 250 mg ultramicrocrystalline griseofulvin tablets were found to be bioequivalent to the physically altered (crushed) 250 mg ultramicrocrystalline griseofulvin tablets (See Table 1).

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Griseofulvin in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Griseofulvin in the drug label.

# How Supplied
- Gris-PEG (griseofulvin ultramicrosize) Tablets, 125 mg, white scored, elliptical-shaped, embossed "Gris-PEG" on one side and "125" on the other. Gris-PEG (griseofulvin ultramicrosize) Tablets, 250 mg, white scored, capsule-shaped, embossed "Gris-PEG" on one side and "250" on the other. The 125 mg strength is available in bottles of 100 (NDC 0884-0763-04). The 250 mg strength is available in bottles of 100 (NDC 0884-0773-04). Both strengths are film-coated.
- Store Gris-PEG  tablets at controlled room temperature 15 - 30C (59 - 86F) in tight, light-resistant containers.

## Storage
There is limited information regarding Griseofulvin Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Griseofulvin in the drug label.

# Precautions with Alcohol
- Alcohol-Griseofulvin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Gris-PEG

# Look-Alike Drug Names
There is limited information regarding Griseofulvin Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price