Version May 2024
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 (Ref).
Microsize: Oral: 1 g/day in single or divided doses (Ref).
Ultramicrosize: Oral: 750 mg/day in single or divided doses (Ref).
Duration: >4 months (eg, 6 to 9 months (Ref)) for fingernail and >6 months (eg, 12 to 18 months (Ref)) for toenail infection (Ref).
Tinea infections:
Dermatophyte folliculitis (tinea barbae, Majocchi granuloma) (alternative agent):
Microsize: Oral: 500 mg/day in single or divided doses (Ref).
Ultramicrosize: Oral: 375 mg/day in single or divided doses.
Duration: 4 to 8 weeks or until clinical resolution (Ref).
Tinea capitis:
Microsize: Oral: 500 mg to 1 g/day in single or divided doses (Ref).
Ultramicrosize: Oral: 375 to 750 mg/day in single or divided doses (Ref).
Duration: 4 to 6 weeks according to the manufacturer’s labeling, but based on experience in pediatrics, up to 12 weeks may be required (Ref).
Tinea corporis/tinea cruris (alternative agent):
Note: Alternative treatment for patients with extensive skin involvement or in whom topical therapy failed (Ref).
Microsize: Oral: 500 mg to 1 g/day in single or divided doses (Ref).
Ultramicrosize: Oral: 375 to 500 mg/day in single or divided doses (Ref).
Duration: 2 to 4 weeks (Ref).
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 (Ref). Griseofulvin has lower efficacy for tinea pedis than other systemic agents (Ref).
Microsize: Oral: 1 g/day in single or divided doses (Ref).
Ultramicrosize: Oral: 750 mg/day in divided doses (Ref).
Duration: 4 to 8 weeks (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Use is contraindicated in hepatic failure.
Refer to adult dosing.
(For additional information see "Griseofulvin: Pediatric drug information")
General dosing; susceptible infection (Ref): 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: Note: Preferred therapy for Microsporum canis infection; may be used in combination with adjunctive topical therapy (eg, selenium or antifungal shampoo) (Ref). Patients receiving doses on the lower end of the dose range may require longer durations of treatment for fungal eradication (Ref).
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 (Ref)
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 (Ref). Although lower doses (10 to 15 mg/kg/day) have been suggested previously by experts (Ref) and by the manufacturer, they are associated with extended treatment durations and/or potentially lower cure rates and have fallen out of favor (Ref).
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 (Ref)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
All patients: Use is contraindicated in hepatic failure.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Postmarketing:
Dermatologic: Erythema multiforme (Hidajat 2014), severe dermatological reaction (including Stevens-Johnson syndrome, toxic epidermal necrolysis) (Araujo 1990), skin photosensitivity (Araujo 1990)
Endocrine & metabolic: Porphyria (Araujo 1990)
Gastrointestinal: Abdominal cramps (Araujo 1990), anorexia (Araujo 1990), diarrhea (Araujo 1990), epigastric discomfort, flatulence (Araujo 1990), gastrointestinal hemorrhage, nausea (Araujo 1990), oral candidiasis, vomiting (Araujo 1990)
Genitourinary: Proteinuria (Bhat 2016)
Hematologic & oncologic: Disorder of hemostatic components of blood, leukopenia
Hepatic: Hepatitis, hepatotoxicity, hyperbilirubinemia, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, jaundice
Hypersensitivity: Angioedema, drug reaction with eosinophilia and systemic symptoms (Maiolo 2016), hypersensitivity reaction (Quero 1960), serum sickness (Araujo 1990)
Nervous system: Confusion, dizziness (Araujo 1990), fatigue (Araujo 1990), headache (Araujo 1990), insomnia (Araujo 1990), paresthesia, peripheral neuropathy
Neuromuscular & skeletal: Exacerbation of systemic lupus erythematosus (Madhok 1985), lupus erythematosus, lupus-like syndrome
Renal: Acute kidney injury (Bhat 2016), nephrosis
Hypersensitivity to griseofulvin or any component of the formulation; hepatic failure; porphyria; pregnancy
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 (pityriasis versicolor).
Microsized formulations: 500 mg tablet and suspension
Ultramicrosize formulation: 125 mg and 250 mg tablets
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Oral:
Generic: 125 mg/5 mL (118 mL, 120 mL)
Tablet, Oral:
Generic: 125 mg, 250 mg, 500 mg
Yes
Suspension (Griseofulvin Microsize Oral)
125 mg/5 mL (per mL): $0.65 - $2.50
Tablets (Griseofulvin Microsize Oral)
500 mg (per each): $8.80 - $9.35
Tablets (Griseofulvin Ultramicrosize Oral)
125 mg (per each): $4.69 - $4.99
250 mg (per each): $6.00 - $6.37
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.
Oral: Administer with a fatty meal to increase absorption (Ref).
Additional formulation-specific administration information:
Ultramicrosize formulation (125 mg and 250 mg tablets): May be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.
Suspension: Shake well before use.
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.
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 (pityriasis versicolor).
Tinea manuum
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.
None known.
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
Chlorprothixene: Griseofulvin may enhance the adverse/toxic effect of Chlorprothixene. Specifically, the risk for acute porphyrias may be increased. 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 and Oral [Non-Absorbable]) 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
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.
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.
Griseofulvin crosses the placenta (Pacifici 2006). Adverse events have been observed in humans (two cases of conjoined twins); therefore, use during pregnancy is contraindicated.
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.
Periodic renal, hepatic, and hematopoietic function tests especially with long-term use
Inhibits fungal cell mitosis at metaphase; binds to human keratin making it resistant to fungal invasion
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
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
