Drugs List

Therapeutic Indications

Uses

Dermatoses
Infected intertrigo
Insect bites
Psoriasis excluding widespread plaque psoriasis

Treatment of inflammatory dermatoses normally responsive to topical corticosteroids where secondary bacterial and/or fungal infection is present, suspected or likely including:
Eczema
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Neurodermatoses
Seborrhoeic dermatitis
Contact sensitivity reactions
Discoid lupus erythematosus

Treatment of secondary infected insect bites
Treatment of anal and genital intertrigo

Contraindications

Children under 1 year
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Rosacea

Precautions and Warnings

Breastfeeding
Pregnancy

Careful supervision of patients with psoriasis required
May mask symptoms or signs of infections
Use appropriate antimicrobial therapy in infected lesions
Exclude fungal infection before treatment
Exclude primary bacterial infection before treatment
Exclude viral infection before treatment
Avoid use in or near eyes
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Cleanse skin thoroughly before applying occlusive dressings
Do not use over large areas of the body
If accidental contact with the eyes occurs, rinse thoroughly with water
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Extended or recurrent use may increase the risk of contact sensitisation
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Risk of generalised pustular psoriasis with use of topical corticosteroids
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Discontinue if no improvement occurs within 7 days
If infection persists use systemic antibiotics. If it spreads stop steroid
Avoid long-term use particularly in infants and children
Limit use in infants or on face to 5 days and without occlusion
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
Stains clothes and skin
Stains hair

Facial areas may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids more than other body areas. This should be considered when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is required.

Appropriate microbial therapy should be used whenever treating inflammatory lesions that have become infected. Any spread of infection will require withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. If occlusive dressings are to be used, care should be taken to ensure the skin is cleansed before a clean dressing is applied.

Pregnancy and Lactation

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. Short-term use of clioquinol in pregnancy over limited areas and relevant indications is also acceptable.

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 14-17 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

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. No specific precautions have been recommended for betamethasone valerate with clioquinol.

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

Allergic contact dermatitis
Burning sensation (local)
Cushing's syndrome
Exacerbation of symptoms
Hypersensitivity reactions
Hypertrichosis
Pruritus
Pustular psoriasis
Skin pigmentation changes
Striae (irreversible)
Superficial vascular dilation
Suppression of the hypothalamic-pituitary-adrenal axis
Thinning of skin

Presentation

Topical formulations containing betamethasone valerate and clioquinol

Drugs List

Therapeutic Indications

Uses

Dermatoses
Infected intertrigo
Insect bites
Psoriasis excluding widespread plaque psoriasis

Treatment of inflammatory dermatoses normally responsive to topical corticosteroids where secondary bacterial and/or fungal infection is present, suspected or likely including:
Eczema
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Neurodermatoses
Seborrhoeic dermatitis
Contact sensitivity reactions
Discoid lupus erythematosus

Treatment of secondary infected insect bites
Treatment of anal and genital intertrigo

Dosage

Clioquinol and betamethasone cream is often appropriate for moist or weeping surfaces, and the ointment is often appropriate for dry, lichenified or scaly lesions, however this is not invariably so.

Adults

Elderly

Children

Contraindications

Children under 1 year
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Rosacea

Precautions and Warnings

Breastfeeding
Pregnancy

Careful supervision of patients with psoriasis required
May mask symptoms or signs of infections
Use appropriate antimicrobial therapy in infected lesions
Exclude fungal infection before treatment
Exclude primary bacterial infection before treatment
Exclude viral infection before treatment
Avoid use in or near eyes
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Cleanse skin thoroughly before applying occlusive dressings
Do not use over large areas of the body
If accidental contact with the eyes occurs, rinse thoroughly with water
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Extended or recurrent use may increase the risk of contact sensitisation
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Risk of generalised pustular psoriasis with use of topical corticosteroids
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Discontinue if no improvement occurs within 7 days
If infection persists use systemic antibiotics. If it spreads stop steroid
Avoid long-term use particularly in infants and children
Limit use in infants or on face to 5 days and without occlusion
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
Stains clothes and skin
Stains hair

Facial areas may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids more than other body areas. This should be considered when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is required.

Appropriate microbial therapy should be used whenever treating inflammatory lesions that have become infected. Any spread of infection will require withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. If occlusive dressings are to be used, care should be taken to ensure the skin is cleansed before a clean dressing is applied.

Pregnancy and Lactation

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. Short-term use of clioquinol in pregnancy over limited areas and relevant indications is also acceptable.

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 14-17 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

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. No specific precautions have been recommended for betamethasone valerate with clioquinol.

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

Allergic contact dermatitis
Burning sensation (local)
Cushing's syndrome
Exacerbation of symptoms
Hypersensitivity reactions
Hypertrichosis
Pruritus
Pustular psoriasis
Skin pigmentation changes
Striae (irreversible)
Superficial vascular dilation
Suppression of the hypothalamic-pituitary-adrenal axis
Thinning of skin

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 2013

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

BNF for Children (2012-2013) 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, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Betamethasone valerate and clioquinol 1mg/30mg/g cream. Essential Generics. Revised March 2012.
Summary of Product Characteristics: Betamethasone valerate and clioquinol 1mg/30mg/g ointment. Essential Generics. Revised March 2012.