Drugs List

Therapeutic Indications

Uses

POM products

Potent antimycotic against dermatophytes and yeast. Indicated for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea manus, tinea pedis and tinea cruris infections due to Trichophyton spp, Microsporum spp and Epidermophyton spp. Also indicated for the treatment of cutaneous candidosis (vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

P products

Treatment of the following mycotic infections: candidal intertrigo (sweat rash), tinea pedis(athletes foot) and tinea cruris (dhobie itch).

GSL products

Treatment of the following mycotic infections: tinea pedis(athletes foot) and tinea cruris (dhobie itch).

Not all available brands are licensed for all indications.

Dosage

Not all available brands are licensed for all indications.

POM products

For the treatment of tinea pedis, ketoconazole should be applied to the affected area twice daily.

For mild infections the duration of treatment is 1 week. For more extensive or severe infections (involving the sides or soles of the feet) treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse.

For other infections, ketoconazole cream should be applied once or twice daily depending on severity of infection.

The treatment should be continued until a few days after the disappearance of all signs and symptoms to prevent relapse. The usual duration of treatment is 2 to 3 weeks for pityriasis versicolor infection and 3 to 4 weeks for tinea corporis.

The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or re-infection.

Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

P products

For the treatment of tinea pedis, ketoconazole should be applied to the affected area twice daily.

For mild infections the duration of treatment is 1 week. For more extensive or severe infections (involving the sides or soles of the feet) treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse.

For the treatment of candidal intertrigo and tinea cruris, ketoconazole cream should be applied to the affected area once or twice daily. Treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse. Treatment for up to 6 weeks may be required.

A doctor should be consulted if no improvement in symptoms is seen after 4 weeks of treatment.

GSL products

For the treatment of tinea pedis, ketoconazole cream should be applied thinly to the affected area twice daily.

For mild infections the usual duration of treatment is 1 week. For more extensive or severe infections (involving the sides or soles of the feet) treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse.

A doctor should be consulted if no improvement in symptoms is seen after 7 days of treatment.

For the treatment of tinea cruris, ketoconazole cream should be applied to the affected area once or twice daily. Treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse. Treatment for up to 6 weeks may be necessary.

A doctor should be consulted if no improvement in symptoms is seen after 4 weeks of treatment.

Contraindications

None known.

Precautions and Warnings

If a potent topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using ketoconazole cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.

Refer to doctor if no clinical improvement is seen after 4 weeks of self treatment.

Pregnancy and Lactation

Pregnancy

Topical application of ketoconazole may lead to systemic absorption but does not produce detectable plasma concentrations in adults. Limited data indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus.
Animal studies have shown reproductive toxicity following oral administration.

Schaefer considers ketoconazole as second choice local antimycotic during pregnancy. Nystatin, clotrimazole, and miconazole are preferred.

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 14-17 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

Topical application of ketoconazole may lead to systemic absorption but does not produce detectable plasma concentrations in adults.

Topical use of ketoconazole by the mother poses little or no risk to the breastfed infant. However, nursing mothers should avoid topical use on the breast or nipples due to possible oral ingestion by the infant and the availability of safer alternatives.

Schaefer considers nystatin, clotrimazole and miconazole as local antimycotics of choice during breastfeeding.

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

Irritation (localised)
Hypersensitivity reactions
Contact dermatitis
Burning sensation
Erythema at application site
Itching at application site
Bleeding skin
Skin discomfort
Dry skin
Inflammation (application site)
Localised areas of paraesthesia
Bullous eruption
Rash
Skin exfoliation
Sticky skin
Urticaria

Presentation

Cream containing ketoconazole 2% w/w

Drugs List

Therapeutic Indications

Uses

POM products

Potent antimycotic against dermatophytes and yeast. Indicated for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea manus, tinea pedis and tinea cruris infections due to Trichophyton spp, Microsporum spp and Epidermophyton spp. Also indicated for the treatment of cutaneous candidosis (vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

P products

Treatment of the following mycotic infections: candidal intertrigo (sweat rash), tinea pedis(athletes foot) and tinea cruris (dhobie itch).

GSL products

Treatment of the following mycotic infections: tinea pedis(athletes foot) and tinea cruris (dhobie itch).

Not all available brands are licensed for all indications.

Dosage

Not all available brands are licensed for all indications.

POM products

For the treatment of tinea pedis, ketoconazole should be applied to the affected area twice daily.

For mild infections the duration of treatment is 1 week. For more extensive or severe infections (involving the sides or soles of the feet) treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse.

For other infections, ketoconazole cream should be applied once or twice daily depending on severity of infection.

The treatment should be continued until a few days after the disappearance of all signs and symptoms to prevent relapse. The usual duration of treatment is 2 to 3 weeks for pityriasis versicolor infection and 3 to 4 weeks for tinea corporis.

The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or re-infection.

Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

P products

For the treatment of tinea pedis, ketoconazole should be applied to the affected area twice daily.

For mild infections the duration of treatment is 1 week. For more extensive or severe infections (involving the sides or soles of the feet) treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse.

For the treatment of candidal intertrigo and tinea cruris, ketoconazole cream should be applied to the affected area once or twice daily. Treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse. Treatment for up to 6 weeks may be required.

A doctor should be consulted if no improvement in symptoms is seen after 4 weeks of treatment.

GSL products

For the treatment of tinea pedis, ketoconazole cream should be applied thinly to the affected area twice daily.

For mild infections the usual duration of treatment is 1 week. For more extensive or severe infections (involving the sides or soles of the feet) treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse.

A doctor should be consulted if no improvement in symptoms is seen after 7 days of treatment.

For the treatment of tinea cruris, ketoconazole cream should be applied to the affected area once or twice daily. Treatment should continue until, and for a few days after, signs and symptoms have disappeared in order to prevent relapse. Treatment for up to 6 weeks may be necessary.

A doctor should be consulted if no improvement in symptoms is seen after 4 weeks of treatment.

Contraindications

None known.

Precautions and Warnings

If a potent topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using ketoconazole cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.

Refer to doctor if no clinical improvement is seen after 4 weeks of self treatment.

Pregnancy and Lactation

Pregnancy

Topical application of ketoconazole may lead to systemic absorption but does not produce detectable plasma concentrations in adults. Limited data indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus.
Animal studies have shown reproductive toxicity following oral administration.

Schaefer considers ketoconazole as second choice local antimycotic during pregnancy. Nystatin, clotrimazole, and miconazole are preferred.

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 14-17 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

Topical application of ketoconazole may lead to systemic absorption but does not produce detectable plasma concentrations in adults.

Topical use of ketoconazole by the mother poses little or no risk to the breastfed infant. However, nursing mothers should avoid topical use on the breast or nipples due to possible oral ingestion by the infant and the availability of safer alternatives.

Schaefer considers nystatin, clotrimazole and miconazole as local antimycotics of choice during breastfeeding.

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

Irritation (localised)
Hypersensitivity reactions
Contact dermatitis
Burning sensation
Erythema at application site
Itching at application site
Bleeding skin
Skin discomfort
Dry skin
Inflammation (application site)
Localised areas of paraesthesia
Bullous eruption
Rash
Skin exfoliation
Sticky skin
Urticaria

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 ).

Reference Sources

British National Formulary, 61st Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Daktarin Gold 2% cream. McNeil Products Ltd. Revised November 2009.

Summary of Product Characteristics: Daktarin Intensive cream. McNeil Products Ltd. Revised February 2010.

Summary of Product Characteristics: Nizoral 2% cream. Janssen-Cilag Ltd. Revised June 2011.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ketoconazole Last revised: January 31, 2011
Last accessed: September 06, 2011