Drugs List

Therapeutic Indications

Uses

Scalp dermatoses responsive to topical corticosteroids

Contraindications

Children under 1 year
Pregnancy
Skin infection

Precautions and Warnings

Children under 6 years
Occlusive dressings
Breastfeeding

Careful supervision of patients with psoriasis required
Not all available brands are licensed for use in children under 6 years
Avoid contact with eyes
Avoid contact with mucous membranes
Product is highly flammable - administer away from naked flame
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Rebound effect may occur after cessation of treatment
Risk of generalised pustular psoriasis with use of topical corticosteroids
Tolerance may develop with continued use
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Treat secondary infection and consider stopping steroid treatment
Treatment normally for a maximum of 5-7 days in children
Advise patient to allow the treated scalp to dry naturally

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy.

There is inadequate evidence of safety in human pregnancy of topical betamethasone. Reduced placental and birth weight have been reported after long term use.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation.

Systemic preparations of betamethasone have been used in premature labour where the benefit is determined to outweigh the risk.

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

Use with caution in breastfeeding.

Betamethasone valerate is excreted into breast milk. Corticosteroids are excreted in small amounts in breast milk, and both Schaefer (2007) and Briggs (2011) report that there are no reports to date of the use of betamethasone during lactation.

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
Headache
Hypersensitivity reactions
Hypertrichosis
Pruritus
Pustular psoriasis
Skin pigmentation changes
Stinging
Striae
Superficial vascular dilation
Suppression of the hypothalamic-pituitary-adrenal axis
Thinning of skin

Presentation

Topical formulations for the scalp containing betamethasone valerate

Drugs List

Therapeutic Indications

Uses

Scalp dermatoses responsive to topical corticosteroids

Dosage

Long term use, especially in children, should be avoided.

Use with occlusion increases the risk of side effects and its use should be minimised.

Adults

Elderly

Children

Contraindications

Children under 1 year
Pregnancy
Skin infection

Precautions and Warnings

Children under 6 years
Occlusive dressings
Breastfeeding

Careful supervision of patients with psoriasis required
Not all available brands are licensed for use in children under 6 years
Avoid contact with eyes
Avoid contact with mucous membranes
Product is highly flammable - administer away from naked flame
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Rebound effect may occur after cessation of treatment
Risk of generalised pustular psoriasis with use of topical corticosteroids
Tolerance may develop with continued use
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Treat secondary infection and consider stopping steroid treatment
Treatment normally for a maximum of 5-7 days in children
Advise patient to allow the treated scalp to dry naturally

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy.

There is inadequate evidence of safety in human pregnancy of topical betamethasone. Reduced placental and birth weight have been reported after long term use.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation.

Systemic preparations of betamethasone have been used in premature labour where the benefit is determined to outweigh the risk.

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

Use with caution in breastfeeding.

Betamethasone valerate is excreted into breast milk. Corticosteroids are excreted in small amounts in breast milk, and both Schaefer (2007) and Briggs (2011) report that there are no reports to date of the use of betamethasone during lactation.

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
Headache
Hypersensitivity reactions
Hypertrichosis
Pruritus
Pustular psoriasis
Skin pigmentation changes
Stinging
Striae
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: February 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: Betacap scalp application. Dermal Laboratories Ltd. Revised June 2008.
Summary of Product Characteristics: Bettamousse. RPH Pharmaceuticals AB. revised June 2011.
Summary of Product Characteristics: Betnovate scalp application. GlaxoSmithKline. Revised June 2014.