Drugs List

Therapeutic Indications

Uses

Fungal infection of skin
Inflammatory skin conditions with bacterial and/or candida infection

For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist e.g. intertrigo and infected eczema.

Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.

Intertriginous eczema including inflammatory intertrigo, perianal and genital dermatitis.

Athlete's foot and candidal intertrigo where there are co-existing symptoms of inflammation.

Organisms which are susceptible to miconazole are dermophytes and pathogenic yeasts (e.g. Candida spp.). Also many gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

Contraindications

Rosacea
Skin manifestation of tuberculosis
Widespread plaque psoriasis

Precautions and Warnings

Children under 10 years
Elderly
Occlusive dressings
Breastfeeding
Perioral dermatitis
Pregnancy

Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Avoid contact with eyes
If visual disturbances occur, perform ophthalmic evaluation
Monitor patients receiving concurrent anticoagulants
Adrenal suppression may occur even without occlusion
Elderly patients may be more susceptible to local and systemic effects
Discontinue if hypersensitivity reactions occur
Discontinue if irritation or sensitisation occur
Avoid long-term use particularly in infants and children
Maximum treatment 7 days unless on doctor's advice
Male & female: May damage latex condoms and diaphragms
Advise patient may damage synthetic material including clothing
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to take care when applying to the face
Fire hazard: Keep away from naked flames and potential sources of ignition
Nappy may act as an occlusive dressing

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with miconazole with caution in pregnancy.

There is limited published information regarding the use of topical hydrocortisone with miconazole in pregnancy.

Manufacturer advises as a precautionary measure to avoid topical hydrocortisone with miconazole in pregnancy.

Briggs (2015) recommends miconazole should not be applied to large areas of skin at any time during pregnancy and does not provide advice on topical hydrocortisone.

Corticosteroids are known to cross the placenta.

In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses.

Animal studies have shown that administration of corticosteroids can cause abnormalities of foetal development including cleft palate, cataracts, intrauterine growth retardation, spontaneous abortion and polycystic kidney disease. The relevance of these findings to humans has not been established.

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

Use hydrocortisone with miconazole with caution in breastfeeding.

There is limited published information regarding the use of topical hydrocortisone with miconazole in breastfeeding.

The manufacturer recommends to either discontinue breastfeeding or to discontinue/abstain from treatment with hydrocortisone with miconazole in breastfeeding.

Lactmed (2015) suggests that since only systemic application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short term application of topical hydrocortisone would pose a risk to the breastfed infant by passage into breast milk.

Miconazole has poor oral bioavailability so it is unlikely to adversely affect the breastfed infant.

It is particularly important to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.

Excess cream or ointment should be removed from the breast or nipples prior to nursing.

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

Adrenal suppression
Anaphylactic reaction
Angioedema
Application site reaction
Blurred vision
Burning sensation
Contact dermatitis
Erythema
Hypersensitivity reactions
Inflammation (application site)
Irritability
Pruritus
Rash
Skin depigmentation
Skin irritation
Urticaria
Visual disturbances

Presentation

Topical formulations containing hydrocortisone and miconazole nitrate.

Drugs List

Therapeutic Indications

Uses

Fungal infection of skin
Inflammatory skin conditions with bacterial and/or candida infection

For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist e.g. intertrigo and infected eczema.

Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.

Intertriginous eczema including inflammatory intertrigo, perianal and genital dermatitis.

Athlete's foot and candidal intertrigo where there are co-existing symptoms of inflammation.

Organisms which are susceptible to miconazole are dermophytes and pathogenic yeasts (e.g. Candida spp.). Also many gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

Dosage

Adults

Children

Contraindications

Rosacea
Skin manifestation of tuberculosis
Widespread plaque psoriasis

Precautions and Warnings

Children under 10 years
Elderly
Occlusive dressings
Breastfeeding
Perioral dermatitis
Pregnancy

Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Avoid contact with eyes
If visual disturbances occur, perform ophthalmic evaluation
Monitor patients receiving concurrent anticoagulants
Adrenal suppression may occur even without occlusion
Elderly patients may be more susceptible to local and systemic effects
Discontinue if hypersensitivity reactions occur
Discontinue if irritation or sensitisation occur
Avoid long-term use particularly in infants and children
Maximum treatment 7 days unless on doctor's advice
Male & female: May damage latex condoms and diaphragms
Advise patient may damage synthetic material including clothing
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to take care when applying to the face
Fire hazard: Keep away from naked flames and potential sources of ignition
Nappy may act as an occlusive dressing

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with miconazole with caution in pregnancy.

There is limited published information regarding the use of topical hydrocortisone with miconazole in pregnancy.

Manufacturer advises as a precautionary measure to avoid topical hydrocortisone with miconazole in pregnancy.

Briggs (2015) recommends miconazole should not be applied to large areas of skin at any time during pregnancy and does not provide advice on topical hydrocortisone.

Corticosteroids are known to cross the placenta.

In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses.

Animal studies have shown that administration of corticosteroids can cause abnormalities of foetal development including cleft palate, cataracts, intrauterine growth retardation, spontaneous abortion and polycystic kidney disease. The relevance of these findings to humans has not been established.

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

Use hydrocortisone with miconazole with caution in breastfeeding.

There is limited published information regarding the use of topical hydrocortisone with miconazole in breastfeeding.

The manufacturer recommends to either discontinue breastfeeding or to discontinue/abstain from treatment with hydrocortisone with miconazole in breastfeeding.

Lactmed (2015) suggests that since only systemic application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short term application of topical hydrocortisone would pose a risk to the breastfed infant by passage into breast milk.

Miconazole has poor oral bioavailability so it is unlikely to adversely affect the breastfed infant.

It is particularly important to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.

Excess cream or ointment should be removed from the breast or nipples prior to nursing.

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

Adrenal suppression
Anaphylactic reaction
Angioedema
Application site reaction
Blurred vision
Burning sensation
Contact dermatitis
Erythema
Hypersensitivity reactions
Inflammation (application site)
Irritability
Pruritus
Rash
Skin depigmentation
Skin irritation
Urticaria
Visual disturbances

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: July 2018.

Reference Sources

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: Daktacort Cream. Janssen-Cilag Ltd. Revised April 2018.
Summary of Product Characteristics: Daktacort Ointment. Janssen-Cilag Ltd. Revised April 2018.
Summary of Product Characteristics: Daktacort Hydrocortisone Cream. McNeil Products Ltd. Revised May 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 July 2018

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: 10 March 2015.
Last accessed: 15 June 2018.

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
Miconazole. Last revised: 7 September 2013.
Last accessed: 15 June 2018.