CURATODERM OINTMENT 4-G/G

Active substance: TACALCITOL MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

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 dennatitis 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 hyperproliferation 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 1α, 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 . 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
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
01/08/2010

10

DATE OF REVISION OF THE TEXT
01/08/2010

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)