Drugs List

Therapeutic Indications

Uses

Skin conditions responsive to topical corticosteroids

POM preparations
Clobetasone butyrate is suitable for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis (including nappy rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.

P presentations
For short term control and treatment of patches of eczema and dermatitis including atopic eczema and primary irritant and allergic dermatitis.

Contraindications

Acne vulgaris
Perioral dermatitis
Rosacea
Skin infection

Precautions and Warnings

Children under 12 years
Infants in nappies
Breastfeeding
Pregnancy
Psoriasis

Careful supervision of patients with psoriasis required
May mask symptoms or signs of infections
Avoid contact with eyes
Do not apply to broken or secondarily infected skin
Risk of glaucoma if preparation enters eye
If visual disturbances occur, perform ophthalmic evaluation
Adrenal suppression can occur in infants even without occlusion
Corticosteroids may cause growth retardation in children under 18 years
Long term use may cause adrenal suppression
Prolonged use may cause atrophic skin changes
Rebound effect may occur after cessation of treatment
Discontinue if hypersensitivity reactions occur
Discontinue therapy and use antimicrobials if secondary infection occurs
Avoid long-term use particularly in infants and children
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition
Nappy may act as an occlusive dressing

Pregnancy and Lactation

Pregnancy

Use topical clobetasone butyrate with caution during pregnancy.

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

No information is available, at the time of writing, on the use of topical clobetasone butyrate during breastfeeding.

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.

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

Acne (at application site)
Adrenal suppression
Allergic contact dermatitis
Blurred vision
Burning sensation (local)
Cushingoid changes
Erythema
Exacerbation of infection
Exacerbation of psoriasis
Hypersensitivity reactions
Hypertrichosis
Local atrophic changes
Perioral dermatitis
Pruritus
Rash
Skin pigmentation changes
Striae (irreversible)
Thinning of skin
Urticaria
Visual disturbances

Presentation

Topical formulations containing clobetasone butyrate.

Drugs List

Therapeutic Indications

Uses

Skin conditions responsive to topical corticosteroids

POM preparations
Clobetasone butyrate is suitable for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis (including nappy rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.

P presentations
For short term control and treatment of patches of eczema and dermatitis including atopic eczema and primary irritant and allergic dermatitis.

Dosage

Adults

Children

Contraindications

Acne vulgaris
Perioral dermatitis
Rosacea
Skin infection

Precautions and Warnings

Children under 12 years
Infants in nappies
Breastfeeding
Pregnancy
Psoriasis

Careful supervision of patients with psoriasis required
May mask symptoms or signs of infections
Avoid contact with eyes
Do not apply to broken or secondarily infected skin
Risk of glaucoma if preparation enters eye
If visual disturbances occur, perform ophthalmic evaluation
Adrenal suppression can occur in infants even without occlusion
Corticosteroids may cause growth retardation in children under 18 years
Long term use may cause adrenal suppression
Prolonged use may cause atrophic skin changes
Rebound effect may occur after cessation of treatment
Discontinue if hypersensitivity reactions occur
Discontinue therapy and use antimicrobials if secondary infection occurs
Avoid long-term use particularly in infants and children
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition
Nappy may act as an occlusive dressing

Pregnancy and Lactation

Pregnancy

Use topical clobetasone butyrate with caution during pregnancy.

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

No information is available, at the time of writing, on the use of topical clobetasone butyrate during breastfeeding.

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.

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

Counselling

POM ointment preparation
Advise patients to keep away from fire when using this product as it contains paraffin.

P preparations
Advise patients with seborrhoeic dermatitis or psoriasis to seek medical advice before initiating treatment.

Advise patients to consult a doctor in order to confirm diagnosis before initiating treatment at the same area for the third time.

Advise patients not to apply topical clobetasone butyrate to the face, groin, genitals or between toes.

Advise patients maximum treatment length is 7 days. If the condition does not improve after 7 days of treatment, advise patient to consult physician.

Side Effects

Acne (at application site)
Adrenal suppression
Allergic contact dermatitis
Blurred vision
Burning sensation (local)
Cushingoid changes
Erythema
Exacerbation of infection
Exacerbation of psoriasis
Hypersensitivity reactions
Hypertrichosis
Local atrophic changes
Perioral dermatitis
Pruritus
Rash
Skin pigmentation changes
Striae (irreversible)
Thinning of skin
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 2013

Reference Sources

Summary of Product Characteristics: Eumovate Eczema & Dermatitis Cream. GlaxoSmithKline UK. Revised January 2017.
Summary of Product Characteristics: Eumovate Cream. GlaxoSmithKline UK. Revised October 2017.
Summary of Product Characteristics: Eumovate Ointment. GlaxoSmithKline UK. Revised August 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 June 2017