Curatodermm Ointment

Tacalcitol 4µg/g

Curatoderm Ointment provides relief from the discomfort of psoriasis. Curatoderm can be used on all body areas including face, flexures and scalp.

  • Contains tacalcitol, a vitamin D3 analogue which works against the 3 main symptoms of psoriasis:
    • hyperproliferation;
    • disturbed differentiation;
    • inflammation.
  • The only vitamin D3 analogue indicated for all body areas including the face, flexures and scalp
  • Convenient through once daily treatment
    • Studies show once daily application enabled patients to reduce the daily treatment time, 52% saved up to half an hour daily*
    • Physicians judged patient compliance to be ‘very good’ or ‘good’ in 91.3% of cases*
  • Can be used in combination with other anti-psoriatic therapies including UVB therapy

PRESCRIBING INFORMATION:

Curatoderm Ointment 4µg/g contains tacalcitol monohydrate 4.17 µg/g (tacalcitol 4µg/g).

USES:

Psoriasis vulgaris

DOSAGE AND ADMINISTRATION:

Adults and the elderly: Apply sparingly, once daily to the affected areas, preferably at bedtime. The amount applied should not exceed 10g 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.

Contra-indications, warnings, etc:

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

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.

INTERACTIONS:

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.

PREGNANCY AND LACTATION:

Safety in pregnancy has not been established. 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 breast milk.

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.

OVERDOSE:

Application of excessive amounts may lead to hypercalcaemia. Curatoderm, other vitamin D related products or calcium supplements must be stopped until serum calcium returns to normal.

LEGAL CATEGORY:

POM

PRODUCT LICENCE NUMBER:

PL 04758/0014

PRODUCT LICENCE HOLDER:

Hermal Kurt Herrmann, GmbH & Co OHG, Scholtzstrasse 3, D-21465, Reinbek, Germany.

DATE OF PREPERATION:

May 2007

PACK SIZES AND COST:

30g Tube£13.40
60g Tube£23.14
100g Tube£30.86

* Gollnick H and Menke T. Current experience with tacalcitol ointment in the treatment of psoriasis, Cur Med Res and Opin. 1998; 14 (4): 213 – 218

Information about adverse event reporting can be found at www.yellowcard.gov.uk and adverse events should be reported to Hermal UK on 0500 455 456

Curatoderm Ointment Tubes