Griseofulvin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Mycotic diseases of the skin, hair and nails due too Microsporum, Trichophyton or Epidermophyton

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Hepatic impairment
• Porphyria
• Systemic Lupus Erythematosus (SLE)
• Breastfeeding

Cautions

• Breastfeeding
• Systemic lupus erythematosus
• Additional contraceptive methods
• May impair ability to drive and operate machinery
• Alcohol consumption
• Excessive and unnecessary exposure to sunlight
• Prolonged griseofulvin therapy

Forms avail. in SA and covered in this monograph: tab

Infections caused by Dermatophytes (including, Microsporum, Epidermophyton, Trichophyton)

General dosing range

• Oral (tab): 500-1000mg/day, in 4 divided doses; Max: 2g/24hrs; Treatment duration: 2-12months

Take with or after meals

Men should not father children within 6 months of treatment

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Tinea capitus
Tinea cruris
Tinea corporis

• Oral (tab): 500-1000mg/day, in 4 divided doses; Max: 2g/24hrs; Treatment duration: 2-6 months

Tinea unguium

• Oral (tab): 500-1000mg/day, in 4 divided doses; Max: 2g/24hrs; Treatment duration: Fingernails: 6-9 months; Toenails: 1 year

Paed. forms avail. in SA and covered in this monograph: tab

Infections caused by Dermatophytes (including, Microsporum, Epidermophyton, Trichophyton)

General dosing range

• Oral (tab): 10mg/kg/day, in 4 divided doses; Treatment duration: 2-12 months

Take with or after meals

Men should not father children within 6 months of treatment

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Tinea capitus
Tinea cruris
Tinea corporis

• Oral (tab): 10mg/kg/day, in 4 divided doses; Treatment duration: 2-6 months

Tinea unguium

• Oral (tab): 10mg/kg/day, in 4 divided doses; Treatment duration: Fingernails: 6-9 months; Toenails: 1 year

Pregnancy

• Contraindicated
• Systemic treatment with griseofulvin should be avoided in pregnancy. Griseofulvin crosses the placenta and has been found to be teratogenic in animal reproductive studies

Breastfeeding 

• Contraindicated 
• It is unknown if griseofulvin is excreted in breast milk, but the possibility does exist
• There is inadequate data on the safety of griseofulvin in breastfeeding, and the potential risk to the infant cannot be assessed, therefore griseofulvin is contraindicated in breastfeeding

Fertility

• Griseofulvin has been shown to induce chromosomal aberrations in animal spermatocytes. Therefore men should take effective contraceptive precautions, i.e. barrier contraception, to avoid fathering children for the duration of griseofulvin therapy, and for 6 months post-therapy cessation

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Contraindicated

Elderly

• No dose adjustment recommended

Porphyria Information

• Porphyrinogenic (P)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Paraesthesia
• Depression
• Confusion
• Dizziness
• Insomnia 
• Fatigue
• Peripheral neuritis

Gastrointestinal Disorders

• Dry mouth
• Altered taste sensation
• Gastrointestinal disturbances
• Oral thrush

Hepatobiliary Disorders

• Hepatotoxicity

Genitourinary Disorders

• Proteinuria

Skin and Subcutaneous Tissue Disorders

• Skin rash
• Angioedema
• Erythema multiform
• Toxic epidermal necrolysis
• Photosensitisation

Immune, Blood and Lymphatic System Disorders

• Leukopenia
• Blood dyscrasias
• Candidiasis
• Granulocytopenia

• Phenobarbitone
• Coumarin anticoagulants
• Oral contraceptives
• Aspirin
• Ciclosporin
• Methadone
• Doxercalciferol
• Phenylbutazone
• Primidone

• Renal function
• Hepatic function
• Full blood count

Therapeutic Effects

Griseofulvin is not effective in infections due to Candida albicans, Aspergillus sp,. MMalassezia furfur (Pittyriasis versiclor), Nocardia sp. It has no antibacterial effects

Alcohol Co-administration

Consumption of alcohol in association with griseofulvin can result in an "Antabuse" type reaction. Patients should be cautioned to avoid consumption of alcoholic beverages, and medicines containing alcohol, while undergoing griseofulvin therapy

Griseofulvin is an antifungal with in vitro activity against various species of Microsporum, Epidermophyton, and Trichophyton. 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. Once the keratin-griseofulvin complex reaches the skin site of action, it binds to fungal microtubules (tubulin) thus altering fungal mitosis.

Spectrum of activity: Dermatophytes (including, Microsporum, Epidermophyton, Trichophyton)

Tablet 125mg

• Microcidal (Pharmacare)

Tablet 500mg

• Microcidal (Pharmacare)