Calcipotriol 50micrograms/g ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcipotriol

Available from:

Sandoz Ltd

ATC code:

D05AX02

INN (International Name):

Calcipotriol

Dosage:

50microgram/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050200; GTIN: 05050650025026 05050650025064 05050650025071

Summary of Product characteristics

OBJECT 1
CALCIPOTRIOL OINTMENT 50MICROGRAMS/G
Summary of Product Characteristics Updated 14-Feb-2018 | Sandoz
Limited
1. Name of the medicinal product
Calcipotriol Ointment 50micrograms/g
2. Qualitative and quantitative composition
One gram of ointment contains 0.05 mg (is equal to 50 micrograms) of
calcipotriol.
Excipient with known effect: Propylene glycol 10 mg/g
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Ointment
White to off-white ointment.
4. Clinical particulars
4.1 Therapeutic indications
Calcipotriol Ointment 50micrograms/g is indicated for the topical
treatment of mild to moderately severe
psoriasis (psoriasis vulgaris).
4.2 Posology and method of administration
Posology
_Adults:_
As monotherapy
Calcipotriol Ointment 50micrograms/g should be applied to the affected
skin on limbs or trunk once or
twice daily. At the beginning of treatment, twice daily (morning and
evening) application is
recommended. For maintenance therapy, the frequency of application may
be decreased to once daily,
depending on the response.
Ointment has to be applied as a thin layer to affected skin with
gentle rubbing to cover the affected area
until most of the ointment disappears.
The maximum amount of ointment applied should not exceed 100 grams per
week. If it is used together
with cream or solution containing calcipotriol, the total weekly dose
of calcipotriol should not exceed 5
mg (for example 40 ml scalp solution plus 60 g of cream or ointment).
The duration of therapy depends on the clinical appearance. A
pronounced therapeutic effect is generally
seen after a maximum of 4-8 weeks. Therapy can be repeated.
As combination therapy
Once daily application in combination with topical corticosteroids
(e.g. administration of Calcipotriol
Ointment 50micrograms/g in the morning and steroid in the evening) is
effective and well tolerated.
_Renal/hepatic impairment_
Patients with known severe renal or liver impairment should not be
treated with calcipotriol.
_Children and adolescents (under 18 years)_
The