Drugs List

Therapeutic Indications

Uses

Skin disorder - mild inflammatory

For the treatment of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.

Contraindications

Acute exudative dermatoses
Perioral dermatitis
Rosacea
Skin infection
Skin ulcer

Precautions and Warnings

Children under 10 years
Breastfeeding
Pregnancy

Contains propylene glycol: may cause irritation
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Avoid prolonged application to the face
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Do not apply to broken or denuded skin
Do not apply to periorbital skin
Do not apply to raw exudative dermatosis
If accidental contact with eyes or mucous membranes - rinse with cool water
Use sparingly
Prolonged continuous use increases the risk of systemic toxicity
Discontinue if irritation or sensitisation occur
Maximum treatment 7 days unless on doctor's advice
Advise patient residue on clothing/bedding may cause fire hazard
Contact doctor if no improvement occurs
Fire hazard: Keep away from naked flames and potential sources of ignition

Pregnancy and Lactation

Pregnancy

Use topical hydrocortisone with crotamiton with caution in pregnancy.

Schaefer concludes that there is no objection to topical therapy with glucocorticoids as long as treatment time is brief and the area covered is moderately sized. The manufacturer suggests use of topical hydrocortisone with crotamiton during pregnancy is not recommended, especially in the first three months.

At the time of writing there is limited published information regarding the use of topical hydrocortisone with crotamiton during pregnancy. Less than 1% of crotamiton is absorbed after dermal application.

Hydrocortisone crosses the human placenta to the foetus. Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus but the relevance of this study has not been established in humans. Nevertheless, topical corticosteroids with the exception of very potent steroids can be used relatively safely in pregnancy.

It is recommended to avoid using large amounts and for long periods of time if possible.

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 topical hydrocortisone with crotamiton with caution in breastfeeding.

The manufacturer suggests breastfeeding women should not use topical hydrocortisone with crotamiton unless under medical supervision.

Corticosteroids generally appear only in low levels in human breast milk and the levels achieved from systemic absorption of topical applications are likely to be minimal. It is not known whether crotamiton or its metabolite(s) pass into the breast milk after topical administration.

If applied to the breast area, the area should be washed and dried prior to breastfeeding and the preparation applied afterwards.

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

Angioedema
Contact dermatitis
Eczema
Erythema
Hypersensitivity reactions
Hypertrichosis
Irritation (localised)
Perioral dermatitis
Pruritus
Rash
Skin atrophy
Steroid acne
Striae
Telangiectasia

Presentation

Cream containing hydrocortisone and crotamiton

Drugs List

Therapeutic Indications

Uses

Skin disorder - mild inflammatory

For the treatment of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.

Dosage

Adults

Elderly

Children

Contraindications

Acute exudative dermatoses
Perioral dermatitis
Rosacea
Skin infection
Skin ulcer

Precautions and Warnings

Children under 10 years
Breastfeeding
Pregnancy

Contains propylene glycol: may cause irritation
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Avoid prolonged application to the face
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Do not apply to broken or denuded skin
Do not apply to periorbital skin
Do not apply to raw exudative dermatosis
If accidental contact with eyes or mucous membranes - rinse with cool water
Use sparingly
Prolonged continuous use increases the risk of systemic toxicity
Discontinue if irritation or sensitisation occur
Maximum treatment 7 days unless on doctor's advice
Advise patient residue on clothing/bedding may cause fire hazard
Contact doctor if no improvement occurs
Fire hazard: Keep away from naked flames and potential sources of ignition

Pregnancy and Lactation

Pregnancy

Use topical hydrocortisone with crotamiton with caution in pregnancy.

Schaefer concludes that there is no objection to topical therapy with glucocorticoids as long as treatment time is brief and the area covered is moderately sized. The manufacturer suggests use of topical hydrocortisone with crotamiton during pregnancy is not recommended, especially in the first three months.

At the time of writing there is limited published information regarding the use of topical hydrocortisone with crotamiton during pregnancy. Less than 1% of crotamiton is absorbed after dermal application.

Hydrocortisone crosses the human placenta to the foetus. Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus but the relevance of this study has not been established in humans. Nevertheless, topical corticosteroids with the exception of very potent steroids can be used relatively safely in pregnancy.

It is recommended to avoid using large amounts and for long periods of time if possible.

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 topical hydrocortisone with crotamiton with caution in breastfeeding.

The manufacturer suggests breastfeeding women should not use topical hydrocortisone with crotamiton unless under medical supervision.

Corticosteroids generally appear only in low levels in human breast milk and the levels achieved from systemic absorption of topical applications are likely to be minimal. It is not known whether crotamiton or its metabolite(s) pass into the breast milk after topical administration.

If applied to the breast area, the area should be washed and dried prior to breastfeeding and the preparation applied afterwards.

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

Angioedema
Contact dermatitis
Eczema
Erythema
Hypersensitivity reactions
Hypertrichosis
Irritation (localised)
Perioral dermatitis
Pruritus
Rash
Skin atrophy
Steroid acne
Striae
Telangiectasia

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: January 2014

Reference Sources

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

Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on January 07, 2014].

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013. Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com [Accessed on January 07, 2014].

Summary of Product Characteristics: Eurax Hc cream. Novartis Consumer Health. Revised December 2013.

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: January 16, 2014.
Last accessed: January 21, 2014.