Drugs List

Therapeutic Indications

Uses

Dermatophytosis unresponsive to topical therapy

Treatment of fungal infections of skin, scalp, hair or nails where topical therapy is inappropriate or has been unsuccessful. Oral griseofulvin enables newly formed keratin of the skin, hair and nails to resist fungal infection. As the new keratin extends, the old infected keratin is shed.

Griseofulvin is effective against the dermatophytes causing ringworm (tinea), including Microsporum canis and T. Verrucosum. It is not effective against infections caused by Candida albicans (monilia), Aspergilli, Malassezia furfur (Pityriasis versicolor) and Nocardia species.

Contraindications

Acute porphyria
Breastfeeding
Pregnancy
Severe hepatic impairment
Systemic lupus erythematosus

Precautions and Warnings

Not for prophylactic use
Advise patient drowsiness may affect ability to drive or operate machinery
Consult national/regional policy on the use of anti-infectives
Monitor hepatic function in patients with hepatic impairment
Advise patient that the effects of alcohol may be potentiated
Female: Contraception required during and for 1 month after treatment
Female: Oral contraception may not be adequate during treatment
Male: Contraception required during and for 6 months after treatment

Pregnancy and Lactation

Pregnancy

Griseofulvin is contraindicated during pregnancy.

Griseofulvin crosses the placenta at term and in animal studies it has demonstrated teratogenicity and at high doses, cancerogenicity (Schaefer, 2015).

Although there have been some reports on the use of griseofulvin in pregnancy and its effect on foetal development, the data is limited and thus a conclusion regarding its safety in pregnancy has not yet been made (Briggs, 2015).

As griseofulvin is not indicated for life threatening infections, its use during pregnancy should be avoided. If, however, griseofulvin is administered in the first trimester, an ultrasound is recommended to ensure normal foetal development (Schaefer, 20015)

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Griseofulvin is contraindicated during breastfeeding.

It is not known if griseofulvin is excreted in human breast milk. Safety for the breast-feeding neonate has not been established. Briggs (2015) suggests griseofulvin is avoided during breastfeeding as there are safer alternatives available.

When systemic antifungals are considered necessary during pregnancy, fluconazole should be used, if the sensitivity of the pathogen permits (Schaefer, 2015).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute renal failure
Agitation
Altered liver function tests
CNS effects
Confusion
Depression
Diarrhoea
Dizziness
Drowsiness
Dysgeusia
Dyspepsia
Erythema multiforme
Fatigue
Gastric discomfort
Glossitis
Headache
Hepatotoxicity
Impaired co-ordination
Irregular menstruation
Leucopenia
Nausea
Neutropenia
Peripheral neuropathy
Photosensitivity
Rash
Sleep disturbances
Systemic lupus erythematosus
Toxic epidermal necrolysis
Urticaria
Vomiting

Presentation

Oral formulations containing griseofulvin

Drugs List

Therapeutic Indications

Uses

Dermatophytosis unresponsive to topical therapy

Treatment of fungal infections of skin, scalp, hair or nails where topical therapy is inappropriate or has been unsuccessful. Oral griseofulvin enables newly formed keratin of the skin, hair and nails to resist fungal infection. As the new keratin extends, the old infected keratin is shed.

Griseofulvin is effective against the dermatophytes causing ringworm (tinea), including Microsporum canis and T. Verrucosum. It is not effective against infections caused by Candida albicans (monilia), Aspergilli, Malassezia furfur (Pityriasis versicolor) and Nocardia species.

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Acute porphyria
Breastfeeding
Pregnancy
Severe hepatic impairment
Systemic lupus erythematosus

Precautions and Warnings

Not for prophylactic use
Advise patient drowsiness may affect ability to drive or operate machinery
Consult national/regional policy on the use of anti-infectives
Monitor hepatic function in patients with hepatic impairment
Advise patient that the effects of alcohol may be potentiated
Female: Contraception required during and for 1 month after treatment
Female: Oral contraception may not be adequate during treatment
Male: Contraception required during and for 6 months after treatment

Pregnancy and Lactation

Pregnancy

Griseofulvin is contraindicated during pregnancy.

Griseofulvin crosses the placenta at term and in animal studies it has demonstrated teratogenicity and at high doses, cancerogenicity (Schaefer, 2015).

Although there have been some reports on the use of griseofulvin in pregnancy and its effect on foetal development, the data is limited and thus a conclusion regarding its safety in pregnancy has not yet been made (Briggs, 2015).

As griseofulvin is not indicated for life threatening infections, its use during pregnancy should be avoided. If, however, griseofulvin is administered in the first trimester, an ultrasound is recommended to ensure normal foetal development (Schaefer, 20015)

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Griseofulvin is contraindicated during breastfeeding.

It is not known if griseofulvin is excreted in human breast milk. Safety for the breast-feeding neonate has not been established. Briggs (2015) suggests griseofulvin is avoided during breastfeeding as there are safer alternatives available.

When systemic antifungals are considered necessary during pregnancy, fluconazole should be used, if the sensitivity of the pathogen permits (Schaefer, 2015).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Griseofulvin may decrease the efficacy of oral contraceptives. Additional barrier methods of contraception should be adopted during treatment and for one month after treatment cessation.

Side Effects

Acute renal failure
Agitation
Altered liver function tests
CNS effects
Confusion
Depression
Diarrhoea
Dizziness
Drowsiness
Dysgeusia
Dyspepsia
Erythema multiforme
Fatigue
Gastric discomfort
Glossitis
Headache
Hepatotoxicity
Impaired co-ordination
Irregular menstruation
Leucopenia
Nausea
Neutropenia
Peripheral neuropathy
Photosensitivity
Rash
Sleep disturbances
Systemic lupus erythematosus
Toxic epidermal necrolysis
Urticaria
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Griseofulvin 125mg tablets. Essential Generics. Revised April 2015.
Summary of Product Characteristics: Griseofulvin 500mg tablets. Essential Generics. Revised April 2015.