Drugs List

Contraindications

Untreated bacterial skin infections
Untreated viral skin infections (e.g. herpes simplex, shingles)
Chicken pox
Vaccination reactions
Perioral dermatitis

Products available for OTC sale have different licensed uses and the following additional contraindications apply:

Children under 10 years, unless prescribed by a doctor.
Pregnancy or breastfeeding, unless prescribed by a doctor.
Do not use on the face.
Do not use on the ano-genital area, unless prescribed by a doctor.
Ringworm, unless prescribed by a doctor.
Secondarily infected skin conditions, unless prescribed by a doctor.

Precautions and Warnings

Not all available brands are licensed for all indications.

Long term continuous therapy should be avoided, especially in infants and children. The maximum period of treatment is 7 days.

Do not use on broken skin, eyes, mucous membranes or on large areas of skin i.e. more than 5-10% body surface to reduce the possibility of systemic steroid absorption.

The treated area should not be covered with an occlusive dressing as hydrocortisone absorption may be increased. In infants the nappy may also act as an occlusive dressing.

Avoid prolonged use on the face. Not suitable for use on acne or rosacea.

Latex contraceptives may be damaged by clotrimazole with hydrocortisone cream and consequently their efficacy may be reduced. Alternative precautions should therefore be adopted during and for five days after treatment.

Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section.

Pregnancy and Lactation

Pregnancy

The data available on the use of hydrocortisone with clotrimazole by topical administration during pregnancy is limited and so it should only be used when deemed necessary by a physician.

When applied regularly over a large area of skin, absorption of hydrocortisone should be considered likely. Hydrocortisone and cortisone both cross the placenta. Studies indicate that much of the hydrocortisone crossing the placenta is converted into its inactive metabolite, cortisone. Maternal treatment with glucocorticosteroids does not appear to represent a major teratogenic risk, though various adverse outcomes have been observed and they may be linked to corticosteroid use. Concerns have been raised that there may be an increased risk in oral clefts and decreased birth weight, but this has not yet been established. Likewise questions remain about possible effects on foetal growth and increased susceptibility in adults, exposed in utero, to conditions such as diabetes and cardiovascular disorders. Depending on the dose and treatment interval, adrenal cortical insufficiency in the newborn could occur, at least with systemic treatment.

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, cataracts, Intrauterine growth retardation (IUGR), polycystic kidney disease, also an increase in spontaneous abortions. Topical administration of corticosteroids to pregnant animals has been reported to cause abnormal foetal development. The relevance of this to humans has not been established.

Animal studies using clotrimazole have demonstrated no teratogenic effects, but oral administration of high dose clotrimazole has been linked to foetotoxicity in rats. The relevance of this to topical administration in human pregnancy is unknown. Systemic absorption of clotrimazole is minimal. Clotrimazole has been used during human pregnancy for over a decade without related adverse effects. Schaefer considers it a topical antimycotic of choice in pregnancy (Schaefer 2007).

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

The data available on the use of hydrocortisone with clotrimazole by topical administration during breastfeeding is limited and so it should only be used when deemed necessary by a physician.

There is limited data available, on the possible effects of hydrocortisone on the nursing infant. However, most authorities consider it unlikely that short term application of hydrocortisone would be a hazard to the breastfeeding infant. It would be advisable to ensure that the infant's skin does not come into contact with any treated area and to wash off any cream used on the breast and nipple area, before breastfeeding.

Clotrimazole has minimal absorption from the skin and has poor oral bioavailability, it is not anticipated that measurable amounts of clotrimazole will appear in human breast milk. Most authorities consider clotrimazole to be compatible with 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

Hypersensitivity reactions (syncope, hypotension, dyspnea, urticaria).
Blisters
Discomfort
Local pain
Oedema (at application site)
Exfoliation
Pruritus
Rash
Local burning sensation
Local irritation
Itching
Erythema

After use on large areas or for longer than 2 - 4 weeks or under occlusive dressings, local skin changes may occur such as:
Skin atrophy
Telangiectasis
Hypertrichosis
Striae
Acneiform symptoms
Hypopigmentation
Secondary infection

Drugs List

Dosage

Adults

Elderly

Children

Contraindications

Untreated bacterial skin infections
Untreated viral skin infections (e.g. herpes simplex, shingles)
Chicken pox
Vaccination reactions
Perioral dermatitis

Products available for OTC sale have different licensed uses and the following additional contraindications apply:

Children under 10 years, unless prescribed by a doctor.
Pregnancy or breastfeeding, unless prescribed by a doctor.
Do not use on the face.
Do not use on the ano-genital area, unless prescribed by a doctor.
Ringworm, unless prescribed by a doctor.
Secondarily infected skin conditions, unless prescribed by a doctor.

Precautions and Warnings

Not all available brands are licensed for all indications.

Long term continuous therapy should be avoided, especially in infants and children. The maximum period of treatment is 7 days.

Do not use on broken skin, eyes, mucous membranes or on large areas of skin i.e. more than 5-10% body surface to reduce the possibility of systemic steroid absorption.

The treated area should not be covered with an occlusive dressing as hydrocortisone absorption may be increased. In infants the nappy may also act as an occlusive dressing.

Avoid prolonged use on the face. Not suitable for use on acne or rosacea.

Latex contraceptives may be damaged by clotrimazole with hydrocortisone cream and consequently their efficacy may be reduced. Alternative precautions should therefore be adopted during and for five days after treatment.

Pregnancy - see Pregnancy section.
Breastfeeding - see Lactation section.

Pregnancy and Lactation

Pregnancy

The data available on the use of hydrocortisone with clotrimazole by topical administration during pregnancy is limited and so it should only be used when deemed necessary by a physician.

When applied regularly over a large area of skin, absorption of hydrocortisone should be considered likely. Hydrocortisone and cortisone both cross the placenta. Studies indicate that much of the hydrocortisone crossing the placenta is converted into its inactive metabolite, cortisone. Maternal treatment with glucocorticosteroids does not appear to represent a major teratogenic risk, though various adverse outcomes have been observed and they may be linked to corticosteroid use. Concerns have been raised that there may be an increased risk in oral clefts and decreased birth weight, but this has not yet been established. Likewise questions remain about possible effects on foetal growth and increased susceptibility in adults, exposed in utero, to conditions such as diabetes and cardiovascular disorders. Depending on the dose and treatment interval, adrenal cortical insufficiency in the newborn could occur, at least with systemic treatment.

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, cataracts, Intrauterine growth retardation (IUGR), polycystic kidney disease, also an increase in spontaneous abortions. Topical administration of corticosteroids to pregnant animals has been reported to cause abnormal foetal development. The relevance of this to humans has not been established.

Animal studies using clotrimazole have demonstrated no teratogenic effects, but oral administration of high dose clotrimazole has been linked to foetotoxicity in rats. The relevance of this to topical administration in human pregnancy is unknown. Systemic absorption of clotrimazole is minimal. Clotrimazole has been used during human pregnancy for over a decade without related adverse effects. Schaefer considers it a topical antimycotic of choice in pregnancy (Schaefer 2007).

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

The data available on the use of hydrocortisone with clotrimazole by topical administration during breastfeeding is limited and so it should only be used when deemed necessary by a physician.

There is limited data available, on the possible effects of hydrocortisone on the nursing infant. However, most authorities consider it unlikely that short term application of hydrocortisone would be a hazard to the breastfeeding infant. It would be advisable to ensure that the infant's skin does not come into contact with any treated area and to wash off any cream used on the breast and nipple area, before breastfeeding.

Clotrimazole has minimal absorption from the skin and has poor oral bioavailability, it is not anticipated that measurable amounts of clotrimazole will appear in human breast milk. Most authorities consider clotrimazole to be compatible with 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

Counselling

Spread thinly on affected area.

Avoid contact with eyes or mucous membranes. Do not use on large areas. Do not cover with an occlusive dressing.

The maximum period of treatment is 7 days.

Latex contraceptives may be damaged by clotrimazole with hydrocortisone cream and consequently their efficacy may be reduced. The patient should be advised to adopt alternative precautions during and for five days after treatment.

Side Effects

Hypersensitivity reactions (syncope, hypotension, dyspnea, urticaria).
Blisters
Discomfort
Local pain
Oedema (at application site)
Exfoliation
Pruritus
Rash
Local burning sensation
Local irritation
Itching
Erythema

After use on large areas or for longer than 2 - 4 weeks or under occlusive dressings, local skin changes may occur such as:
Skin atrophy
Telangiectasis
Hypertrichosis
Striae
Acneiform symptoms
Hypopigmentation
Secondary infection

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 ).

Shelf Life and Storage

Do not store above 25 degrees C.

Reference Sources

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

British National Formulary, 62nd Edition (2011) 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.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Patient Information Leaflet for Canesten HC Cream, Bayer Plc, December 2009.
Summary of Product Characteristics for Canesten HC Cream, Bayer Plc, July 2010.

Summary of Product Characteristics for Canesten Hydrocortisone , Bayer Plc, July 2010.

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
Clotrimazole. Last revised:31 January 2011
Last accessed: 17 October 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
Hydrocortisone. Topical. Last revised:31 January 2011
Last accessed: 17 October 2011