Calcipotriol with betamethasone topical
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Topical formulations containing calcipotriol (as calcipotriol hydrate) and betamethasone (as betamethasone dipropionate).
Drugs List
Therapeutic Indications
Uses
Plaque psoriasis
Psoriasis - scalp
Ointment and foam
Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.
Gel
Topical treatment of scalp psoriasis.
Topical treatment for mild to moderate "non scalp" plaque psoriasis vulgaris.
Cream
Topical treatment of mild to moderate psoriasis vulgaris including scalp psoriasis.
Dosage
Adults
Ointment and foam
One application to the affected area once daily. The maximum daily dose is 15g, the recommended treatment period is 4 weeks and the treated area should not be more than 30% of the body surface.
Long-term maintenance treatment (foam formulation)
Patients that respond at 4 weeks' treatment are suitable for long-term maintenance treatment.
One application twice weekly on two non-consecutive days to areas previously affected. Between applications there should be 2 to 3 days without treatment.
Gel
For treatment of the scalp
Apply 1g to 4g daily (4g corresponds to one teaspoonful). The recommended treatment period is 4 weeks. Shampoo off after leaving on the scalp overnight or during the day, not recommended to take a shower, bath or to wash hair before.
For treatment of non scalp areas
One application to the affected area once daily. Recommended treatment period is 8 weeks. Subsequent courses should be initiated after medical review.
Cream
One application to the affected areas once daily. The recommended treatment period is up to 8 weeks. Discontinue treatment when control is achieved. Allow 8 hours between the application and showering. Immediate shower or bath is not recommended after application.
Treat on all affected scalp areas.
Children
Children aged 12 to 18 years (unlicensed):
Total maximum 75g weekly when different calcipotriol preparations are used together.
Stable plaque psoriasis and mild to moderate psoriasis
Gel/ointment: Apply once daily to a maximum of 30% of body surface for up to 4 weeks.
Scalp psoriasis
Gel: 1g to 4g applied to scalp once daily, shampoo off after leaving on scalp overnight or during the day. Usual duration of therapy is 4 weeks.
Contraindications
Children under 12 years
Concurrent ultraviolet light therapy
Open wounds
Acne vulgaris
Disorder of calcium metabolism
Erythrodermic exfoliative psoriasis
Fragile skin veins
Ichthyosis
Perioral dermatitis
Pregnancy
Pustular psoriasis
Rosacea
Severe hepatic disorder
Severe renal impairment
Skin atrophy
Skin infection
Skin manifestation of tuberculosis
Skin ulcer
Striae atrophicae
Precautions and Warnings
Children aged 12 to 18 years
Breastfeeding
Diabetes mellitus
Patients with diabetes may experience fluctuations in blood glucose
Unsuitable for widespread small lesions, pustular or acute psoriasis
Not all available brands are licensed for all indications
Some formulations contain butylated hydroxy toluene (E321)
Some formulations contain butylhydroxyanisole (E320)
Some formulations contain macrogolglycerol hydroxystearate
Advise patient not to apply to more than 30% body surface
Advise patient to wash hands after use
Avoid contact with eyes, lips or mouth
Avoid contact with mucous membranes
Avoid occlusive dressings
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Do not apply to atrophic skin
Do not apply to genitalia
Do not apply to intertriginous skin
Do not apply to large areas of abraded or damaged skin
Not to be applied to the face
Prolonged use/application to large areas of broken skin may inc. absorption
If visual disturbances occur, perform ophthalmic evaluation
Possible systemic absorption of steroid
Increased risk of hypercalcaemia if maximum weekly dose of 100g exceeded
Prolonged/excessive use may lead to adrenal suppression
Rebound effect may occur after cessation of treatment
Risk of generalised pustular psoriasis with use of topical corticosteroids
Discontinue therapy and use antimicrobials if secondary infection occurs
Maximum adult dose of calcipotriol from all formulations - 5mg per week
Advise patient maximum daily dose should not be more than 15 grams
Advise patient residue on clothing/bedding may cause fire hazard
Avoid excessive exposure to sunlight
Avoid excessive exposure to UV light
Fire hazard: Keep away from naked flames and potential sources of ignition
The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are fulfilled. Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose of 15 g of the gel and ointment is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued.
The risk of systemic absorption of the steroid component is increased if occlusive dressings are used or if the preparation is applied to large areas or for prolonged periods to areas of damaged skin, on mucous membranes or skin folds. Long term corticosteroid use is associated with an increased risk of local and systemic adverse effects. If such effects occur, treatment should be discontinued. Adverse effects occurring following systemic corticosteroid use include adrenal cortex suppression or alterations to the metabolic control of diabetes mellitus.
Some manufacturers advise patients to limit or avoid excessive exposure to natural and UV light.
Avoid concurrent treatment with other steroids on the same treatment area.
Pregnancy and Lactation
Pregnancy
Calcipotriol and betamethasone is contraindicated during pregnancy.
The manufacturer suggests topical calcipotriol with betamethasone should only be used when the potential benefit justifies the potential risk. At the time of writing there is limited published information regarding the use of calcipotriol with betamethasone during pregnancy. Animal studies with glucocorticoids have shown reproductive toxicity, but a number of epidemiological studies have not revealed congenital anomalies. The potential risk for humans is uncertain.
Lactation
Use calcipotriol with betamethasone with caution during breastfeeding.
The manufacturer advises caution if calcipotriol with betamethasone is used when breastfeeding. There are no data are available, at the time of writing, on the use of calcipotriol with betamethasone whilst breastfeeding. Betamethasone passes into breast milk, but the risk of adverse effects on the nursing infant appears to be unlikely at therapeutic doses. At the time of writing, there is no published experience concerning the use of calcipotriol during breastfeeding. The breast area should be wiped off prior to nursing if there has been any topically applied corticosteroid.
Counselling
Advise patient to avoid application and accidental transfer of the ointment or foam to the scalp, face, mouth and eyes. The gel may be used to treat scalp lesions but application of the gel and the cream to the face, mouth or eyes should be avoided.
Advise patient or carer to wash their hands after each application to avoid transfer of the preparation to untreated areas.
Advise patient to avoid excessive exposure to natural or artificial sunlight during therapy.
Side Effects
Acne
Adrenal cortex insufficiency
Allergic contact dermatitis
Angioedema
Application site reaction
Atrophy (localised)
Blurred vision
Burning sensation
Cataracts
Central serous chorioretinopathy
Colloid milia
Decreased glycaemic control in diabetes
Depigmentation of hair
Dermatitis
Dry skin
Ecchymosis
Eczema
Erythema
Exacerbation of psoriasis
Eye irritation
Facial oedema
Folliculitis
Furuncle
Hypercalcaemia
Hypercalciuria
Hypersensitivity reactions
Hypertrichosis
Increased intra-ocular pressure
Infections
Insomnia
Mucosal irritation
Perioral dermatitis
Photosensitivity
Pruritus
Purpura
Pustular psoriasis
Pustular rash
Rash
Skin depigmentation
Skin exfoliation
Skin infection
Skin irritation
Skin pain
Stinging
Striae
Telangiectasia
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: September 2020
Reference Sources
Summary of Product Characteristics: Dalbecal 50 microgram/g + 0.5mg/g ointment. Teva UK Ltd. Revised September 2019.
Summary of Product Characteristics: Dalonev ointment. Mibe Pharma UK Ltd. Revised August 2020.
Summary of Product Characteristics: Dovobet gel. Leo Laboratories Limited. Revised August 2019.
Summary of Product Characteristics: Dovobet ointment. Leo laboratories Limited. Revised August 2018.
Summary of Product Characteristics: Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam. Leo Pharma. Revised February 2021.
Summary of Product Characteristics: Wynzora 50 micrograms/g + 0.5mg/g cream. Almirall, S.A. Revised December 2021.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 05 November 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Betamethasone, topical. Last revised: 31 October 2018
Last accessed: 11 September 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Calcipotriol Last revised: 10 March, 2015.
Last accessed: 14 July, 2015.
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