Drugs List

Therapeutic Indications

Uses

Hyperkeratotic and dry dermatoses
Psoriasis excluding widespread plaque psoriasis

Dosage

Apply a thin layer once or twice daily.

The maximum weekly dose should not exceed 60 g. It is recommended that the treatment should be reviewed after two weeks.

Contraindications

Nappy rash
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Rosacea
Skin infection

Precautions and Warnings

Children under 18 years
Breastfeeding
Pregnancy

Careful supervision of patients with psoriasis required
Treat and control infections prior to commencing therapy
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
May cause local and systemic toxicity especially in prolonged/extensive use
Paediatric patients may be more susceptible to systemic toxicity
Corticosteroids may cause growth retardation in children under 18 years
Prolonged use may cause atrophic skin changes
Prolonged/excessive use may lead to adrenal suppression
Risk of generalised pustular psoriasis with use of topical corticosteroids
Tolerance may develop with continued use
Discontinue if irritation or sensitisation occur
Avoid long term continuous therapy
Limit use in children to 5 days
Limit use on face to 5 days
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition

Children may have a greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression due to a larger skin surface area to body weight ratio meaning a greater chance of absorption.

Supervision is required if used in psoriasis as topical corticosteroids have the potential to be hazardous inlcuding rebound relapses following development of tolerance, risk of pustular psoriasis and developments of local and systemic toxicity due to impaired barrier function of the skin.

Pregnancy and Lactation

Pregnancy

Use betamethasone dipropionate and salicylic acid with caution in pregnancy.

At the time of writing there is limited published information regarding the use of systemic corticosteroids associated with the increased risk of congenital abnormalities in human pregnancy. Briggs (2015) states the use of corticosteroids during the first trimester have been associated with the increased risk of developing a cleft palate, however betamethasone has not been specifically identified in any studies. Corticosteroids should only be used during pregnancy if the potential benefit to the mother outweighs any potential risk to the foetus.

Salicylates have not shown any systemic effects when used appropriately during pregnancy (Schaefer et al, 2015).

The manufacturer suggests to avoid using betamethasone dipropionate with salicylic acid in large amounts or over a long period of time in pregnancy.

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 betamethasone dipropionate and salicylic acid with caution in breastfeeding.

It is not known whether systemic absorption of topical corticosteroids is detectable in breast milk, however the molecular weight of betamethasone dipropionate suggests it is low enough to be excreted in breast milk (Briggs et al, 2015). Hale (2014) categorises betamethasone dipropionate as high potency stating to use with caution and avoid application to the nipple area.

Salicylic acid is well absorbed however Hale (2014) states there is no published information suggesting it can be found excreted in breast milk (Hale et al, 2014). Briggs (2015) states salicylates are excreted in breast milk in low concentrations that increases the risk of adverse effects on platelet function.

The manufacturer suggests to discontinue breastfeeding if using betamethasone dipropionate with salicylic acid.

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)
Acne-like eruptions
Allergic contact dermatitis
Burning sensation (local)
Cushing's syndrome
Dermatitis
Exacerbation of infection
Folliculitis
Growth retardation (children)
Hypersensitivity reactions
Hypertrichosis
Hypopigmentation
Intracranial hypertension
Irritation (localised)
Itching sensation (local)
Local atrophic changes
Miliaria
Perioral dermatitis
Pustular psoriasis
Secondary infections
Skin atrophy
Striae (irreversible)
Superficial vascular dilation
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Thinning of skin
Weight gain

Presentation

Topical formulations of betamethasone dipropionate and salicylic acid

Drugs List

Therapeutic Indications

Uses

Hyperkeratotic and dry dermatoses
Psoriasis excluding widespread plaque psoriasis

Dosage

Apply a thin layer once or twice daily.

The maximum weekly dose should not exceed 60 g. It is recommended that the treatment should be reviewed after two weeks.

Contraindications

Nappy rash
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Rosacea
Skin infection

Precautions and Warnings

Children under 18 years
Breastfeeding
Pregnancy

Careful supervision of patients with psoriasis required
Treat and control infections prior to commencing therapy
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
May cause local and systemic toxicity especially in prolonged/extensive use
Paediatric patients may be more susceptible to systemic toxicity
Corticosteroids may cause growth retardation in children under 18 years
Prolonged use may cause atrophic skin changes
Prolonged/excessive use may lead to adrenal suppression
Risk of generalised pustular psoriasis with use of topical corticosteroids
Tolerance may develop with continued use
Discontinue if irritation or sensitisation occur
Avoid long term continuous therapy
Limit use in children to 5 days
Limit use on face to 5 days
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition

Children may have a greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression due to a larger skin surface area to body weight ratio meaning a greater chance of absorption.

Supervision is required if used in psoriasis as topical corticosteroids have the potential to be hazardous inlcuding rebound relapses following development of tolerance, risk of pustular psoriasis and developments of local and systemic toxicity due to impaired barrier function of the skin.

Pregnancy and Lactation

Pregnancy

Use betamethasone dipropionate and salicylic acid with caution in pregnancy.

At the time of writing there is limited published information regarding the use of systemic corticosteroids associated with the increased risk of congenital abnormalities in human pregnancy. Briggs (2015) states the use of corticosteroids during the first trimester have been associated with the increased risk of developing a cleft palate, however betamethasone has not been specifically identified in any studies. Corticosteroids should only be used during pregnancy if the potential benefit to the mother outweighs any potential risk to the foetus.

Salicylates have not shown any systemic effects when used appropriately during pregnancy (Schaefer et al, 2015).

The manufacturer suggests to avoid using betamethasone dipropionate with salicylic acid in large amounts or over a long period of time in pregnancy.

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 betamethasone dipropionate and salicylic acid with caution in breastfeeding.

It is not known whether systemic absorption of topical corticosteroids is detectable in breast milk, however the molecular weight of betamethasone dipropionate suggests it is low enough to be excreted in breast milk (Briggs et al, 2015). Hale (2014) categorises betamethasone dipropionate as high potency stating to use with caution and avoid application to the nipple area.

Salicylic acid is well absorbed however Hale (2014) states there is no published information suggesting it can be found excreted in breast milk (Hale et al, 2014). Briggs (2015) states salicylates are excreted in breast milk in low concentrations that increases the risk of adverse effects on platelet function.

The manufacturer suggests to discontinue breastfeeding if using betamethasone dipropionate with salicylic acid.

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)
Acne-like eruptions
Allergic contact dermatitis
Burning sensation (local)
Cushing's syndrome
Dermatitis
Exacerbation of infection
Folliculitis
Growth retardation (children)
Hypersensitivity reactions
Hypertrichosis
Hypopigmentation
Intracranial hypertension
Irritation (localised)
Itching sensation (local)
Local atrophic changes
Miliaria
Perioral dermatitis
Pustular psoriasis
Secondary infections
Skin atrophy
Striae (irreversible)
Superficial vascular dilation
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Thinning of skin
Weight gain

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: March 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.

Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Paediatric Formulary Committee. BNF for Children 2016-2017. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2016.

Summary of Product Characteristics: Diprosalic Scalp Application. Merk Sharp & Dohme Ltd. Revised March 2015.

Summary of Product Characteristics: Diprosalic Ointment. Merk Sharp & Dohme Ltd. Revised July 2015.