Curatoderm Ointment

1. Name Of The Medicinal Product

Curatoderm Ointment 4μg/g

2. Qualitative And Quantitative Composition

Tacalcitol monohydrate 4.17 μg/g

(tacalcitol 4 μg/g)

3. Pharmaceutical Form

Ointment

4. Clinical Particulars

4.1 Therapeutic Indications

Psoriasis vulgaris.

4.2 Posology And Method Of Administration

Adults and the Elderly: Apply sparingly, once daily to the affected areas, preferably at bedtime. The amount applied should not exceed l0g of ointment/day. Normally duration of treatment depends on the severity of the lesions and should be decided by the physician. There is clinical trial experience with continuous and intermittent treatment in adults up to twelve months.

Curatoderm Ointment can be used on all areas of the body (including face, hairline, scalp, axilla and other flexures).

When used on the scalp the ointment can be shampooed out the next morning.

Children: Not recommended. There is limited clinical experience in children.

4.3 Contraindications

Hypersensitivity to constituents; in patients with hypercalcaemia or other known disorders of calcium metabolism.

4.4 Special Warnings And Precautions For Use

At the doctor's discretion, in patients at risk of hypercalcaemia, or patients taking high Vitamin D preparations (in excess of 500 IU vitamin D) albumin corrected serum calcium levels should be closely monitored. Treatment should be stopped if hypercalcaemia occurs. Serum calcium levels should also be monitored in patients with renal impairment.

Care should be exercised in patients with generalised pustular or erythrodermic exfoliative psoriasis as the risk of hypercalcaemia may be enhanced.

When applying to the face avoid contact with the eyes. Patients should be advised to wash their hands after applying the ointment to avoid inadvertent transfer to other parts of the body.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions are likely in patients using multivitamin preparations with up to 500 IU vitamin D.

UVB radiation can be combined with Curatoderm Ointment. This approach increases the efficacy of the treatment and shortens the radiation period. UV radiation should be given in the morning and Curatoderm Ointment at bedtime. There has been limited experience of the concomitant use of Curatoderm Ointment with topical corticosteroids, urea, emollients, dithranol cream and PUVA.

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation or peri- or postnatal development. Avoid use in pregnancy unless there are no safer alternatives. During lactation the breast area should not be treated. It is not known whether tacalcitol is excreted in human breast milk.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Local skin reactions (itching, erythema, burning, paraesthesia) have been reported. Other local reactions and in isolated cases contact dermatitis or a worsening of the skin condition may occur. In general, these local reactions are mild and transient.

4.9 Overdose

Overdosing by ingestion of an ointment is very unlikely. It cannot be excluded that topical application of excessive amounts may lead to hypercalcaemia. In this case Curatoderm treatment and other possible vitamin D or calcium supplement intakes must be stopped until serum calcium returns to normal.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: D05A X02.

Tacalcitol is a vitamin D3 derivative, which inhibits keratinocyte hyper-proliferation and induces differentiation of these cells. The normalisation of these mechanisms is the basis for the efficacy in the treatment of psoriasis. In biopsies from patients treated with tacalcitol specific indicators for inflammation were improved. Tacalcitol binds to the keratinocyte vitamin D receptor to the same extent as natural active vitamin D3.

5.2 Pharmacokinetic Properties

Single or repeated application of tacalcitol ointment in humans results in less than 0.5% of the drug being systemically absorbed through psoriatic skin. Tacalcitol is completely bound to plasma proteins (vitamin D binding protein) The main metabolite is 1 α, 24, 25 (OH)3 vitamin D3, a metabolite shared with the natural active vitamin, with 5-10 times less vitamin D activity. Tacalcitol and metabolites are excreted mainly in the faeces in rat and dog studies with excretion in urine in man. It cannot therefore be excluded that if there is sufficient systemic absorption accumulation may occur in patients with renal failure.

5.3 Preclinical Safety Data

Tacalcitol is effective in very low concentrations. The no-effect-level following cutaneous application over 12 months in rat studies amounted to only 4 ng/kg daily. Toxicity is focused to the classic vitamin effects of calciferols. Teratogenicity studies in mice and rats showed no teratogenic effects of tacalcitol. The results of mutagenicity studies (Ames test, chromosomal aberration test and micronucleus test), indicate no genotoxic potential.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White petrolatum, liquid paraffin, diisopropyl adipate.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months at up to 30°C. 6 months after first opening the tube.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tubes with internal lacquer, membrane-sealed opening and plastic screw cap, containing 5g, 20g, 30g, 60g or 100g.

6.6 Special Precautions For Disposal And Other Handling

External use only.

7. Marketing Authorisation Holder

Almirall Hermal GmbH

Scholtzstrasse 3

D-21465,

Reinbek

Germany

8. Marketing Authorisation Number(S)

PL 33016/0012

9. Date Of First Authorisation/Renewal Of The Authorisation

13^th July 2006

10. Date Of Revision Of The Text

31^st July 2010