Drugs List

Therapeutic Indications

Uses

Mild to moderately severe plaque psoriasis involving up to 35% body surface

Contraindications

Children under 12 years
Breastfeeding
Disorder of calcium metabolism
Hepatic impairment
Hypercalcaemia
Renal impairment

Precautions and Warnings

Pregnancy

Advise patient to wash hands after use
Avoid contact with eyes
Avoid occlusive dressings
No more than 35% of body surface area should be exposed to daily treatment
Substances which stimulate absorption must not be added to the ointment
Advise patient to seek medical advice if contact allergy occurs
Discontinue treatment if severe irritation or contact allergy occurs
Maximum 30 grams of ointment should be used per day

Pregnancy and Lactation

Pregnancy

Use calcitriol with caution in pregnancy.

At the time of writing there is limited published information regarding the use of calcitriol during pregnancy. The manufacturer states that research have shown developmental toxicity in animals.

Calcitriol should only be applied in the smallest amount and when necessary. Monitor calcium and serum calcium concentration.

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

Calcitriol is contraindicated in breastfeeding.

At the time of writing there is limited published information regarding the use of calcitriol during breastfeeding.

The manufacturer states that calcitriol has been found in the milk of lactating dams.

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

Contact dermatitis
Dry skin
Erythema
Exacerbation of psoriasis
Hypersensitivity reactions
Increase in plasma and urinary calcium
Oedema
Pruritus
Skin irritation

Presentation

Ointment containing calcitriol

Drugs List

Therapeutic Indications

Uses

Mild to moderately severe plaque psoriasis involving up to 35% body surface

Dosage

Adults

Children

Contraindications

Children under 12 years
Breastfeeding
Disorder of calcium metabolism
Hepatic impairment
Hypercalcaemia
Renal impairment

Precautions and Warnings

Pregnancy

Advise patient to wash hands after use
Avoid contact with eyes
Avoid occlusive dressings
No more than 35% of body surface area should be exposed to daily treatment
Substances which stimulate absorption must not be added to the ointment
Advise patient to seek medical advice if contact allergy occurs
Discontinue treatment if severe irritation or contact allergy occurs
Maximum 30 grams of ointment should be used per day

Pregnancy and Lactation

Pregnancy

Use calcitriol with caution in pregnancy.

At the time of writing there is limited published information regarding the use of calcitriol during pregnancy. The manufacturer states that research have shown developmental toxicity in animals.

Calcitriol should only be applied in the smallest amount and when necessary. Monitor calcium and serum calcium concentration.

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

Calcitriol is contraindicated in breastfeeding.

At the time of writing there is limited published information regarding the use of calcitriol during breastfeeding.

The manufacturer states that calcitriol has been found in the milk of lactating dams.

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

Contact dermatitis
Dry skin
Erythema
Exacerbation of psoriasis
Hypersensitivity reactions
Increase in plasma and urinary calcium
Oedema
Pruritus
Skin irritation

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 2017

Reference Sources

Summary of Product Characteristics: Silkis 3 micrograms per g ointment. Galderma (UK) Ltd. Revised July 2013.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017