Drugs List

Therapeutic Indications

Uses

Topical treatment of plaque psoriasis (psoriasis vulgaris).

Not all brands are licensed for all age groups.

Contraindications

Calcium metabolism disorders
Children under 6 years old
Severe renal impairment
Severe hepatic impairment

Precautions and Warnings

Do not use on face.

Advise patients to wash hands after application to prevent accidental transfer to other body areas, particularly the face.

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are fulfilled. Hypercalcaemia may occur if the maximum weekly dose is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued.
Use with caution in generalised pustular psoriasis and erythrodermic exfoliative psoriasis as there is an increased risk of hypercalcaemia.

Avoid excessive exposure to either artificial or natural sunlight during therapy, as animal studies have suggested that topical calcipotriol may enhance the effect of UV radiation to induce skin tumours. UV radiation should only be used if the physician and patient consider the potential benefits to outweigh the potential risks.

Pregnancy and Lactation

Pregnancy

Manufacturer states that the safety of calcipotriol use during pregnancy has not been established and that its use should be avoided.

Safety of calcipotriol use during human pregnancy has not been established. Animal studies have not shown any teratogenic effects. Limited absorption is expected after local application of calcipotriol preparations to small areas. Use of the recommended doses of calcipotriol does not lead to a disturbance in calcium homeostasis.

It is not known whether calcipotriol crosses the placenta to the foetus. The British Association of Dermatologists (2006) suggests that calcipotriol is not thought to be teratogenic, however, there is little experience of its use. Calcipotriol may cause hypervitaminosis D and hypercalcaemia and should therefore be avoided during pregnancy.

Schaefer (2007) advises that calcipotriol should not be used over large areas, especially in the presence of inflammatory changes in the skin that make absorption more likely.

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

It is preferable to avoid the use of calcipotriol while breastfeeding.

It is not known whether calcipotriol is excreted in breast milk. Approximately 5-6% is transcutaneously absorbed into the systemic circulation (via ointment) but Hale (2010) states that levels of calcipotriol in milk would be virtually nil because vitamin D transport to milk is normally quite low.

At the time of writing, there is no published experience concerning the use of calcipotriol during breastfeeding. Briggs (2011) suggests because calcipotriol is a derivative of an active form of vitamin D its topical use is probably compatible with breastfeeding.

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

Irritation (localised)
Facial dermatitis
Perioral dermatitis
Hypercalcaemia
Dermatitis
Pruritus
Erythema
Psoriasis-exacerbation of
Photosensitivity
Burning sensation (local)
Skin atrophy
Rash
Stinging
Hypercalciuria
Angioedema
Peripheral oedema
Facial oedema
Dry skin
Hyperpigmentation of skin
Allergic reaction
Urticaria
Eczema
Paraesthesia
Itching sensation (local)
Maculopapular rash
Pustular rash
Bullous reactions

Presentation

Cream containing 50 micrograms/g calcipotriol (as calcipotriol hydrate).

Ointment containing 50 micrograms/g calcipotriol.

Drugs List

Therapeutic Indications

Uses

Topical treatment of plaque psoriasis (psoriasis vulgaris).

Not all brands are licensed for all age groups.

Dosage

Individual dosage requirements depend on the extent of the psoriasis but should not exceed the recommended maximum weekly dose.

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Calcium metabolism disorders
Children under 6 years old
Severe renal impairment
Severe hepatic impairment

Precautions and Warnings

Do not use on face.

Advise patients to wash hands after application to prevent accidental transfer to other body areas, particularly the face.

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are fulfilled. Hypercalcaemia may occur if the maximum weekly dose is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued.
Use with caution in generalised pustular psoriasis and erythrodermic exfoliative psoriasis as there is an increased risk of hypercalcaemia.

Avoid excessive exposure to either artificial or natural sunlight during therapy, as animal studies have suggested that topical calcipotriol may enhance the effect of UV radiation to induce skin tumours. UV radiation should only be used if the physician and patient consider the potential benefits to outweigh the potential risks.

Pregnancy and Lactation

Pregnancy

Manufacturer states that the safety of calcipotriol use during pregnancy has not been established and that its use should be avoided.

Safety of calcipotriol use during human pregnancy has not been established. Animal studies have not shown any teratogenic effects. Limited absorption is expected after local application of calcipotriol preparations to small areas. Use of the recommended doses of calcipotriol does not lead to a disturbance in calcium homeostasis.

It is not known whether calcipotriol crosses the placenta to the foetus. The British Association of Dermatologists (2006) suggests that calcipotriol is not thought to be teratogenic, however, there is little experience of its use. Calcipotriol may cause hypervitaminosis D and hypercalcaemia and should therefore be avoided during pregnancy.

Schaefer (2007) advises that calcipotriol should not be used over large areas, especially in the presence of inflammatory changes in the skin that make absorption more likely.

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

It is preferable to avoid the use of calcipotriol while breastfeeding.

It is not known whether calcipotriol is excreted in breast milk. Approximately 5-6% is transcutaneously absorbed into the systemic circulation (via ointment) but Hale (2010) states that levels of calcipotriol in milk would be virtually nil because vitamin D transport to milk is normally quite low.

At the time of writing, there is no published experience concerning the use of calcipotriol during breastfeeding. Briggs (2011) suggests because calcipotriol is a derivative of an active form of vitamin D its topical use is probably compatible with breastfeeding.

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

Advise patients not to use on the face and to wash hands after applying calcipotriol to prevent accidental transfer to other body areas, particularly the face.

Advise patients to avoid excessive exposure to natural or artificial sunlight during therapy.

Side Effects

Irritation (localised)
Facial dermatitis
Perioral dermatitis
Hypercalcaemia
Dermatitis
Pruritus
Erythema
Psoriasis-exacerbation of
Photosensitivity
Burning sensation (local)
Skin atrophy
Rash
Stinging
Hypercalciuria
Angioedema
Peripheral oedema
Facial oedema
Dry skin
Hyperpigmentation of skin
Allergic reaction
Urticaria
Eczema
Paraesthesia
Itching sensation (local)
Maculopapular rash
Pustular rash
Bullous reactions

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 ).

Reference Sources

British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

BNF for Children (2011-2012) 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.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

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

Summary of Product Characteristics: Dovonex Cream. Leo Laboratories Limited. Revised October 2010.
Summary of Product Characteristics: Dovonex Ointment. Leo Laboratories Limited. Revised August 2011.
Summary of Product Characteristics: Calcipotriol Ointment 50 mcg/g. Sandoz Limited. Revised February 2008.