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Griseofulvin: Drug information

Griseofulvin: Drug information
(For additional information see "Griseofulvin: Patient drug information" and see "Griseofulvin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Antifungal Agent, Oral
Dosing: Adult
Onychomycosis

Onychomycosis ( alternative agent):

Note: Reserve for patients unable to use preferred agents due to the increased risk for adverse effects, reduced efficacy, and need for prolonged treatment duration with griseofulvin (Ameen 2014; Kreijkamp-Kaspers 2017).

Microsize: Oral: 1 g/day in single or divided doses (Gupta 2008a; Hofmann 1995; manufacturer’s labeling).

Ultramicrosize: Oral: 750 mg/day in single or divided doses (Gupta 2008a; manufacturer’s labeling).

Duration: >4 months (eg, 6 to 9 months [Ameen 2014]) for fingernail and >6 months (eg, 12 to 18 months [Ameen 2014]) for toenail infection (manufacturer’s labeling).

Tinea infections

Tinea infections:

Dermatophyte folliculitis (tinea barbae, Majocchi granuloma) (alternative agent):

Microsize: Oral: 500 mg/day in single or divided doses (Bonifaz 2003; manufacturer’s labeling).

Ultramicrosize: Oral: 375 mg/day in single or divided doses.

Duration: 4 to 8 weeks or until clinical resolution (Bonifaz 2003; Ilkit 2012; Jackson 2021).

Tinea capitis:

Microsize: Oral: 500 mg to 1 g/day in single or divided doses (El-Khalawany 2013; Gupta 2008b; manufacturer’s labeling).

Ultramicrosize: Oral: 375 to 750 mg/day in single or divided doses (Gupta 2008b; manufacturer’s labeling).

Duration: 4 to 6 weeks according to the manufacturer’s labeling, but based on experience in pediatrics, up to 12 weeks may be required (Gupta 2008a; Gupta 2008b).

Tinea corporis/tinea cruris (alternative agent):

Note: Alternative treatment for patients with extensive skin involvement or in whom topical therapy failed (Goldstein 2021).

Microsize: Oral: 500 mg to 1 g/day in single or divided doses (del Palacio Hernandez 1990; Gupta 2008a; Kahled 2007; Voravutinon 1993).

Ultramicrosize: Oral: 375 to 500 mg/day in single or divided doses (Goldstein 2021; Gupta 2008a; manufacturer’s labeling).

Duration: 2 to 4 weeks (del Palacio Hernandez 1990; Gupta 2008a; Khaled 2007).

Tinea pedis (labeled use)/tinea manuum (off-label use) (alternative agent):

Note: Alternative treatment for patients with extensive skin involvement or in whom topical therapy failed (Goldstein 2021). Griseofulvin has lower efficacy for tinea pedis than other systemic agents (Gupta 2008a).

Microsize: Oral: 1 g/day in single or divided doses (Gupta 2008a).

Ultramicrosize: Oral: 750 mg/day in divided doses (Gupta 2008a; manufacturer’s labeling).

Duration: 4 to 8 weeks (Gupta 2008a).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

Use is contraindicated in hepatic failure.

Dosing: Pediatric

(For additional information see "Griseofulvin: Pediatric drug information")

General dosing; susceptible infection (Bradley 2018; Red Book [AAP 2018]): Children >2 years and Adolescents:

Microsize: Oral: 20 to 25 mg/kg/day in single or 2 divided doses; maximum daily dose: 1,000 mg/day

Ultramicrosize: Oral: 10 to 15 mg/kg/day once daily; maximum daily dose: 750 mg/day

Tinea capitis

Tinea capitis: Note: Preferred therapy for Microsporum canis infection; may be used in combination with adjunctive topical therapy (eg, selenium or antifungal shampoo) (Red Book [AAP 2018]). Patients receiving doses on the lower end of the dose range may require longer durations of treatment for fungal eradication (Shemer 2013).

Infants >1 month to Children ≤2 years: Limited data available: Oral: Microsize: 15 to 25 mg/kg/day in single or 2 divided doses (maximum daily dose: 1,000 mg/day) until resolution; usually 6 to 8 weeks duration, although resistant cases may require longer duration; tinea capitis is rare in ages <1 year, infant dosing based on small case-series/reports (Atanasovski 2011; Fuller 2014; Gupta 2017; Lorch Dauk 2010; Michaels 2012)

Children >2 years and Adolescents:

Microsize: Oral: 20 to 25 mg/kg/day in single daily dose or in 2 divided doses (maximum daily dose: 1,000 mg/day) for 6 to 8 weeks or until fungal cultures clear; in some cases, treatment up to 12 to 18 weeks may be necessary (Ely 2014; Fuller 2014; Gupta 2017; Kakourou 2010; Red Book [AAP 2018]). Although lower doses (10 to 15 mg/kg/day) have been suggested previously by experts (Higgins 2000) and by the manufacturer, they are associated with extended treatment durations and/or potentially lower cure rates and have fallen out of favor (Bradley 2018; Red Book [AAP 2018]).

Ultramicrosize: Oral: 10 to 15 mg/kg/day once daily (maximum daily dose: 750 mg/day) for 6 to 8 weeks or until fungal cultures clear; in some cases, treatment up to 12 to 18 weeks may be necessary (Ali 2007; Ely 2014; Kakourou 2010; Red Book [AAP 2018])

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

All patients: Use is contraindicated in hepatic failure.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

Generic: 125 mg/5 mL (120 mL)

Tablet, Oral:

Generic: 125 mg, 250 mg, 500 mg

Generic Equivalent Available: US

Yes

Dosage Forms Considerations

Microsized formulations: Suspensions

Ultramicrosize formulation: Gris-PEG tablets

Administration: Adult

Oral: Administer with a fatty meal to increase absorption (Red Book [AAP 2015])

Gris-PEG tablets: May be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

Suspension: Shake well before use.

Administration: Pediatric

Oral:

Microsize oral suspension, tablets: Administer with a fatty meal (eg, whole milk, ice cream, peanut butter) to increase absorption; shake suspension well before use.

Ultramicrosize tablets: May be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

Use: Labeled Indications

Dermatophyte infections: Treatment of the following dermatophyte infections of the skin, hair, and nails not adequately treated by topical therapy: Tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following species 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.

Limitations of use: Use for the prophylaxis of fungal infections has not been established; not effective for the treatment of tinea versicolor.

Use: Off-Label: Adult

Tinea manuum

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Confusion, dizziness, fatigue, headache, insomnia

Dermatologic: Dermatological reaction (erythema multiforme-like drug reaction), skin photosensitivity, skin rash (most common), urticaria (most common)

Gastrointestinal: Diarrhea, epigastric distress, gastrointestinal hemorrhage, nausea, oral candidiasis, vomiting

Genitourinary: Nephrosis

Hematologic & oncologic: Granulocytopenia

Hepatic: Hepatotoxicity

<1%, postmarketing, and/or case reports: Angioedema, increased serum bilirubin, increased serum transaminases, leukopenia, lupus-like syndrome, paresthesia, proteinuria, Stevens-Johnson syndrome, toxic epidermal necrolysis

Contraindications

Hypersensitivity to griseofulvin or any component of the formulation; hepatic failure; porphyria; pregnancy

Warnings/Precautions

Concerns related to adverse effects:

• Hematologic effects: Leukopenia has been reported (rare); discontinue therapy if granulocytopenia occurs.

• Hepatic effects: May cause jaundice and elevated liver function tests or bilirubin (may be serious or even fatal); monitor hepatic function and discontinue therapy if necessary.

• Penicillin allergy: Hypersensitivity cross reaction between penicillins and griseofulvin is possible, however, known penicillin-sensitive patients have been treated successfully without complications.

• Photosensitivity: Avoid exposure to intense sunlight to prevent photosensitivity reactions.

• Skin reactions: Severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported (may be serious or even fatal); discontinue use if severe skin reactions occur.

Disease-related concerns:

• Lupus erythematosus: Development of lupus erythematosus, lupus-like syndromes or exacerbation of existing lupus erythematosus has been reported.

Other warnings/precautions:

• Appropriate use: Use for the prophylaxis of fungal infections has not been established; not effective for the treatment of tinea versicolor.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): Griseofulvin may enhance the adverse/toxic effect of Alcohol (Ethyl). A disulfiram-like reaction may occur. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Barbiturates: May decrease the serum concentration of Griseofulvin. Risk C: Monitor therapy

Carbocisteine: Griseofulvin may enhance the adverse/toxic effect of Carbocisteine. Specifically, griseofulvin may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Risk C: Monitor therapy

CycloSPORINE (Systemic): Griseofulvin may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

Hormonal Contraceptives: Griseofulvin may decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing griseofulvin to ensure contraceptive reliability. Risk D: Consider therapy modification

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination

Ulipristal: Griseofulvin may decrease the serum concentration of Ulipristal. Risk X: Avoid combination

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Griseofulvin may decrease the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Food Interactions

Ethanol: Concomitant ethanol use may cause rare disulfiram reaction. Management: Monitor patients.

Food: Griseofulvin concentrations may be increased if taken with food, especially with high-fat meals. Management: Take with a fatty meal (peanuts or ice cream) to increase absorption, or with food or milk to avoid GI upset.

Reproductive Considerations

Females of reproductive potential should use affective contraception during therapy (estrogen containing contraceptives may be less effective). Men should avoid fathering a child for at least 6 months after therapy.

Pregnancy Considerations

Griseofulvin crosses the placenta (Pacifici 2006). Adverse events have been observed in humans (two cases of conjoined twins); therefore, use during pregnancy is contraindicated.

Breastfeeding Considerations

It is not known if griseofulvin is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended.

Monitoring Parameters

Periodic renal, hepatic, and hematopoietic function tests especially with long-term use

Mechanism of Action

Inhibits fungal cell mitosis at metaphase; binds to human keratin making it resistant to fungal invasion

Pharmacokinetics

Absorption: Ultramicrosize griseofulvin absorption is almost complete; absorption of microsize griseofulvin is variable (27% to 72% of an oral dose); enhanced by ingestion of a fatty meal (GI absorption of ultramicrosize is ~1.5 times that of microsize); absorbed from the duodenum

Distribution: Deposited in the keratin layer of skin, hair, and nails; concentrates in liver, fat, and skeletal muscles; Vd: ~1.5 L (Vozeh 1988)

Metabolism: Extensively hepatic

Half-life elimination: 9 to 24 hours

Time to peak, serum: 4 hours

Excretion: Urine (<1% as unchanged drug); feces (~33%); perspiration

Pricing: US

Suspension (Griseofulvin Microsize Oral)

125 mg/5 mL (per mL): $0.65 - $2.50

Tablets (Griseofulvin Microsize Oral)

500 mg (per each): $8.51 - $11.67

Tablets (Griseofulvin Ultramicrosize Oral)

125 mg (per each): $4.69 - $5.75

250 mg (per each): $6.00 - $7.34

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Afuvin (BD);
  • Asfulvin (LK);
  • Biogrisin (PL);
  • Delmofulvina (IT);
  • Fulcin (BR, EC, FI, IT, NO, PT);
  • Fulcin Forte (MX);
  • Fulcin S (DE);
  • Fulcinex (BD);
  • Fulvin G (BD);
  • Fungacin (TW);
  • Fungistop (ID);
  • Fungivin (NO, PK);
  • Fusovin (TH);
  • Gefulvin (TR);
  • Gricin (CZ, DE, HU, PL);
  • Grifulin Forte (IL);
  • Grifulvin (TH);
  • Grisefuline (FR);
  • Grisenova (GR);
  • griseo von ct (DE);
  • Griseofil (LK);
  • Griseofulvin (IE, PL);
  • Griseofulvin Leo (LU);
  • Griseofulvin Prafa (ID);
  • Griseofulvina (IT);
  • Griseomed (AT);
  • Griseon (ZW);
  • Griseovin (EG);
  • Griseovine (VN);
  • Grisflavin (TH);
  • Grisfulvin V (PH);
  • Grisol (CH, GB);
  • Grisomicon (PT);
  • Grisoral (IN, ZW);
  • Grisovin (AE, AT, AU, BH, CO, CR, CY, CZ, DO, GT, HN, IQ, IR, JO, KW, LB, LY, MX, NI, OM, PA, PE, PT, SA, SV, SY, VE, YE);
  • Grisovin F.P. (LK);
  • Grisovin-FP (AR, PH, UY);
  • Grisovina FP (IT);
  • Grisuven (HK);
  • Grisuvin (MY);
  • Grivin (MY, TH);
  • Grivin Forte (ID);
  • Gruvin (TW);
  • Japcin (BD);
  • Krisovin (MY, SG);
  • Likuden (DE);
  • Microcidal (ZA);
  • Pongyl V (KR);
  • Ponzyr V (KR);
  • Rexavin (ID);
  • Trivanex (TH);
  • Ultrafulvin (EG);
  • Ultragriseofulvin (EG, QA)


For country code abbreviations (show table)
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