Classes
DEA Class; Rx
Common Brand Names; Grifulvin V, Gris-PEG
- Antifungals,
- Systemic
Description
Oral antifungal antibiotic produced by certain species of Penicillium. Marketed in several formulations to increase bioavailability and decrease GI intolerance. Used for tinea and other fungal infections, including onychomycosis.NOTE: On April 10, 2007, Ortho-McNeil and the FDA informed of a nationwide recall of griseofulvin oral suspension, due to 2 reports of glass fragments found in bottles of this liquid. The recall is limited to this liquid formulation (roughly 100 lots) from this manufacturer and does not include any other dosage form. The voluntary recall is being conducted by Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc., manufacturer of GRIFULVIN V® and also of griseofulvin oral suspension under the Patriot Pharmaceuticals, L.L.C., label. Consumers should contact their pharmacy to see if they have the product that has been recalled. It is not clear that the recall will cause any shortages.
Indications
Infections affecting skin, body, hair/beard, or nails
Contraindications
Hypersensitivity
Porphyria
Hepatocellular failure
Pregnancy
Adverse Effects
Rash (most common)
Urticaria (most common)
Headache
Fatigue
Dizziness
Insomnia
Mental confusion
Photosensitivity
Nausea
Vomiting
Epigastric distress
Diarrhea
GI bleeding
Leukopenia
Hepatotoxicity
Proteinuria
Nephrosis
Oral thrush
Angioneurotic edema (rare)
Drug-induced lupuslike syndrome (rare)
Menstrual irregularities (rare)
Paresthesia (rare)
Warnings
Severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme reported, some resulting in hospitalization or death; discontinue if severe skin reaction occurs
Elevations in AST, ALT, bilirubin, and jaundice reported, some resulting in hospitalization or death; discontinue if jaundice occurs
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
Pregnancy and Lactation
Pregnancy category: X; no adequate and well-controlled studies in pregnant women, but animal studies have shown embryotoxic and teratogenic effects
Lactation: Excretion in milk unknown; avoid use because of potential tumorigenicity
Maximum Dosage
1 g/day PO of microsize griseofulvin; 750 mg/day PO of ultramicrosize griseofulvin.
1 g/day PO of microsize griseofulvin; 750 mg/day PO of ultramicrosize griseofulvin.
10 mg/kg/day (Max: 500 mg/day) PO of microsize griseofulvin is FDA-approved; however, doses up to 25 mg/kg/day PO (Max: 1 g/day) have been used off-label; 7.3 mg/kg/day (Max: 375 mg/day) PO of ultramicrosize griseofulvin is FDA-approved; however, doses up to 15 mg/kg/day PO (Max: 750 mg/day) have been used off-label.
3 to 12 years: 10 mg/kg/day (Max: 500 mg/day) PO of microsize griseofulvin is FDA-approved; however, doses up to 25 mg/kg/day PO (Max: 1 g/day) have been used off-label; 7.3 mg/kg/day (Max: 375 mg/day) PO of ultramicrosize griseofulvin is FDA-approved; however, doses up to 15 mg/kg/day PO (Max: 750 mg/day) have been used off-label.
1 to 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Griseofulvin
oral suspension, microsize
- 125mg/5mL
tablet, microsize
- 500mg (Grifulvin V)
tablet, ultramicrosize
- 125mg (Gris-PEG)
- 250mg (Gris-PEG)
