Tacalcitol monohydrate topical
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Topical preparations containing tacalcitol
Drugs List
Therapeutic Indications
Uses
Plaque psoriasis
Psoriasis - scalp
Ointment
For the treatment for psoriasis vulgaris.
Lotion
For the treatment of psoriasis vulgaris, especially on the scalp.
Dosage
Adults
Apply sparingly once daily, preferably at bedtime to the affected areas. A maximum of 10 g of ointment, or 10 ml of lotion, can be applied each day. When ointment and lotion are used together, a maximum weekly dose of 280 micrograms of tacalcitol should not be exceeded (e.g. 30 ml of tacalcitol lotion and 40 g of tacalcitol ointment). The duration of treatment depends on the severity of the lesions, and should be decided by the physician.
When tacalcitol is used in combination with UV radiation it increases the efficacy of treatment and shortens the radiation period. UV radiation should be given in the morning and tacalcitol ointment or lotion at bedtime.
There is clinical trial experience with continuous and intermittent treatment in adults with tacalcitol ointment for up to eighteen months and with tacalcitol lotion for up to 8 weeks, which shows no serious or unexpected adverse reactions.
Tacalcitol can be used on all areas of the body (including the face, hairline, scalp, axilla and other flexures). When used on the scalp the ointment can be shampooed out the next morning.
Elderly
(See Dosage; Adult)
Children
Children aged 12 to 18 years
(See Dosage; Adult)
Patients with Renal Impairment
Monitor serum calcium levels in patients with renal impairment.
Contraindications
Children under 12 years
Breastfeeding
Disorder of calcium metabolism
Hypercalcaemia
Pregnancy
Psoriasis punctata
Pustular psoriasis
Severe cardiac disorder
Severe hepatic impairment
Severe renal impairment
Precautions and Warnings
Erythrodermic exfoliative psoriasis
UV radiation treatment should be administered the morning before treatment
Some formulations contain butylated hydroxy toluene (E321)
Some formulations contain propylene glycol
Advise patient to wash hands after use
Avoid contact with eyes
Breastfeeding: Do not treat the breast area if patient breastfeeding
If accidental contact with the eyes occurs, rinse thoroughly with water
Monitor serum calcium levels in patients with renal impairment
Monitor serum calcium on prolonged use or with high doses of vitamin D
Patient at risk of hypercalcaemia-monitor albumin corrected serum Ca levels
Discontinue if hypercalcaemia occurs
Avoid use on normal skin
Pregnancy and Lactation
Pregnancy
Tacalcitol monohydrate is contraindicated during pregnancy.
The manufacturer recommends that tacalcitol monohydrate should be avoided during pregnancy. No clinical data on exposed pregnancies are available. Animal studies have not demonstrated direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. The potential risk to humans is unknown.
Lactation
Tacalcitol monohydrate is contraindicated during breastfeeding.
The manufacturer advises that tacalcitol monohydrate is not indicated for treatment during breastfeeding. Tacalcitol and its main metabolite pass into the milk of rats. It is not known whether tacalcitol is excreted in human milk. Risks to exposed infants is unknown.
Counselling
Patients should be advised to avoid contact with eyes. If accidental contact with the eyes occurs, the area should be thoroughly rinsed with water.
Patients should be advised to wash their hands after use in order to prevent inadvertent transfer of the ointment/lotion to normal skin.
Warn patient that the ointment contains white petrolatum and liquid paraffin, and application in the genital or anal area can reduce the functionality of latex products (e.g. condoms, diaphragms) when used simultaneously and thus impair the reliability of these products.
Side Effects
Burning sensation (local)
Contact dermatitis
Erythema
Exacerbation of psoriasis
Eye irritation
Hypercalcaemia
Itching sensation (local)
Mucosal irritation
Paraesthesia
Skin 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 ).
Further Information
Last Full Review Date: August 2014
Reference Sources
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on August 11, 2014.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com Accessed on August 11, 2014.
Summary of Product Characteristics: Curatoderm ointment 4 micrograms/g. Reckitt Benckiser Healthcare. Revised February 2018.
Summary of Product Characteristics: Curatoderm lotion 4 micrograms/g. Reckitt Benckiser Healthcare. Revised November 2021.
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