Griseofulvin microsized

Class
Antifungal agents
Subclass
Mitotic inhibitors
Substance name
Griseofulvin microsized
Common formulations
Tablet, Suspension
See also
Griseofulvin ultramicrosized (Gris-Peg®)
Dosage and administration
Adults patients
Onychomycosis • Fingernails, caused by dermatophytes
•
1,000 mg PO daily, in a single or divided doses, for at least 4 months
Onychomycosis • Toenails, caused by dermatophytes
•
1,000 mg PO daily, in a single or divided doses, for at least 6 months
Tinea barbae
•
500 mg PO daily, in a single or divided doses, for 4-8 weeks
Tinea capitis
•
500 mg PO daily, in a single or divided doses, for 4-6 weeks
Tinea corporis
•
500 mg PO daily, in a single or divided doses, for 2-4 weeks
Tinea cruris
•
500 mg PO daily, in a single or divided doses, for 2-4 weeks
Tinea pedis
•
1,000 mg PO daily, in a single or divided doses, for 4-8 weeks
Other off-label uses
•
Treatment of lichen planus (cutaneous or oral)
Indications for use
Labeled indications
Adults
•
Treatment of onychomycosis (fingernails, caused by dermatophytes)
•
Treatment of onychomycosis (toenails, caused by dermatophytes)
•
Treatment of tinea barbae
•
Treatment of tinea capitis
•
Treatment of tinea corporis
•
Treatment of tinea cruris
•
Treatment of tinea pedis
Off-label indications
Adults
•
Treatment of lichen planus (cutaneous or oral)
Safety risks
Contraindications
Hypersensitivity to griseofulvin or its components
Liver failure
Porphyria
Warnings and precautions
Breakthrough bleeding, current or recent pregnancy
•
Use caution in patients taking oral contraceptives, as griseofulvin may decrease their effectiveness.
Decreased drug efficacy
•
Use caution in patients taking coumarin anticoagulants. Adjust the anticoagulant dose during and after griseofulvin therapy.
Decreased serum griseofulvin levels
•
Use caution in patients taking barbiturates. Consider increasing griseofulvin dose.
Hepatotoxicity
•
Maintain a high level of suspicion, as griseofulvin has been associated with an increased risk of elevations in serum transaminases, bilirubin, and jaundice.
Photosensitivity of skin, lupus-like symptoms
•
Maintain a high level of suspicion, as griseofulvin has been associated with an increased risk of photosensitivity reactions and lupus-like syndromes. Advise patients to avoid exposure to intense natural or artificial sunlight.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Acute or decompensated chronic liver disease
•
Do not use.
Any severity
•
Use with caution. Monitor serum aminotransferases.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Do not use. Evidence of fetal harm in humans. Advise using effective contraception during treatment and for 1 month after the last dose. Advise male patients not to father children for at least 6 months after the last dose.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Skin rash, urticaria
Common 1-10%
•
Oral candidiasis, nausea, vomiting, diarrhea, headache, epigastric pain, dizziness, fatigue, insomnia, confusion
Rare < 0.1%
•
Hepatitis, ↑ urine protein, ↓ WBC count, paresthesia, angioedema, erythema multiforme-like rash, agranulocytosis, gastrointestinal bleeding, coagulopathy, peripheral neuropathy, jaundice, ↑ serum transaminases, photosensitivity of skin, lupus-like symptoms, ↑ serum TBIL
Interactions
Drug(s)
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