Drugs List

Therapeutic Indications

Uses

Psoriasis - scalp

Contraindications

Children under 6 years
Disorder of calcium metabolism
Hepatic impairment
Hypercalcaemia
Severe renal impairment

Precautions and Warnings

Children aged 6 to 18 years
Concurrent ultraviolet light therapy
Breastfeeding
Erythrodermic exfoliative psoriasis
Pregnancy
Pustular psoriasis

Advise patient to wash hands after use
Avoid occlusive dressings
Do not mix with other drugs or substances
Not to be applied to the face
Avoid excessive exposure to UV light
Patients should not exceed recommended dose

The maximum weekly dose should not be exceeded as hypercalcaemia may occur. This condition resolves rapidly upon treatment cessation.

Pregnancy and Lactation

Pregnancy

Use calcipotriol with caution in pregnancy.

At the time of writing there is limited published information regarding the use of calcipotriol during pregnancy. Animal studies have shown reproductive toxicity when calcipotriol was administrated orally. It is not known whether calcipotriol crosses the human placenta but topically applied calcipotriol has shown systemic absorption, however a calcium homeostasis disruption is not expected. The manufacturer suggests to avoid the use of calcipotriol 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 calcipotriol with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of calcipotriol during breastfeeding. It is not known whether calcipotriol is excreted in breast milk. Less than 1% is absorbed from the scalp when solution is used. It is unlikely plasma levels of calcipotriol would be elevated at all, and milk levels would be virtually nil because vitamin D transport to milk is normally quite low. Adverse effects in a breastfed infant are unlikely in short term use and if the surface area treated is moderate to low. The manufacturer suggests the use of calcipotriol is not recommended in 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

Allergic reaction
Angioedema
Burning sensation (local)
Dermatitis
Dry skin
Eczema
Erythema at application site
Exacerbation of psoriasis
Facial dermatitis
Facial oedema
Hypercalcaemia
Hypercalciuria
Hyperpigmentation of skin
Irritation (localised)
Itching sensation (local)
Perioral dermatitis
Periorbital oedema
Photosensitivity
Pruritus
Rash
Skin atrophy
Stinging
Urticaria

Presentation

Solution containing calcipotriol 50 micrograms per ml as calcipotriol hydrate.

Drugs List

Therapeutic Indications

Uses

Psoriasis - scalp

Dosage

Duration of treatment should not exceed 22 weeks.

Adults

Children

Contraindications

Children under 6 years
Disorder of calcium metabolism
Hepatic impairment
Hypercalcaemia
Severe renal impairment

Precautions and Warnings

Children aged 6 to 18 years
Concurrent ultraviolet light therapy
Breastfeeding
Erythrodermic exfoliative psoriasis
Pregnancy
Pustular psoriasis

Advise patient to wash hands after use
Avoid occlusive dressings
Do not mix with other drugs or substances
Not to be applied to the face
Avoid excessive exposure to UV light
Patients should not exceed recommended dose

The maximum weekly dose should not be exceeded as hypercalcaemia may occur. This condition resolves rapidly upon treatment cessation.

Pregnancy and Lactation

Pregnancy

Use calcipotriol with caution in pregnancy.

At the time of writing there is limited published information regarding the use of calcipotriol during pregnancy. Animal studies have shown reproductive toxicity when calcipotriol was administrated orally. It is not known whether calcipotriol crosses the human placenta but topically applied calcipotriol has shown systemic absorption, however a calcium homeostasis disruption is not expected. The manufacturer suggests to avoid the use of calcipotriol 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 calcipotriol with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of calcipotriol during breastfeeding. It is not known whether calcipotriol is excreted in breast milk. Less than 1% is absorbed from the scalp when solution is used. It is unlikely plasma levels of calcipotriol would be elevated at all, and milk levels would be virtually nil because vitamin D transport to milk is normally quite low. Adverse effects in a breastfed infant are unlikely in short term use and if the surface area treated is moderate to low. The manufacturer suggests the use of calcipotriol is not recommended in 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

Allergic reaction
Angioedema
Burning sensation (local)
Dermatitis
Dry skin
Eczema
Erythema at application site
Exacerbation of psoriasis
Facial dermatitis
Facial oedema
Hypercalcaemia
Hypercalciuria
Hyperpigmentation of skin
Irritation (localised)
Itching sensation (local)
Perioral dermatitis
Periorbital oedema
Photosensitivity
Pruritus
Rash
Skin atrophy
Stinging
Urticaria

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: October 2016

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.

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

Summary of Product Characteristics: Calcipotriol 50 micrograms/ml Scalp Solution. Sandoz Limited. Revised July 2016.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 21 June 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: 26 April 2016
Last accessed: 07 October 2016