DAIVONEX calcipotriol 50 microgram/g ointment

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

calcipotriol, Quantity: 50 microgram/g

Dostępny od:

LEO Pharma Pty Ltd

INN (International Nazwa):

Calcipotriol

Forma farmaceutyczna:

Ointment

Skład:

Excipient Ingredients: disodium edetate; dibasic sodium phosphate dihydrate; dl-alpha-tocopherol; liquid paraffin; steareth-2; propylene glycol; purified water; white soft paraffin

Droga podania:

Topical

Sztuk w opakowaniu:

15, 30, 100g

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Calcipotriol ointment is indicated for the topical treatment of chronic stable plaque type psoriasis vulgaris in adult patients. INDICATIONS AS AT 26 MARCH 2002: DAIVONEX ointment is indicated for the topical treatment of chronic stable plaque type psoriasis vulgaris in adults and children (see Use in Children). In adult patients, DAIVONEX ointment may also be used in combination with either phototherapy, or systemic acitretin or cyclosporin.

Podsumowanie produktu:

Visual Identification: Translucent, white to yellowish ointment.; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

1994-04-26

Charakterystyka produktu

Version 4.0
1
PRODUCT INFORMATION
DAIVONEX
®
OINTMENT
Calcipotriol 50 microgram/g
AUST R 46683
NAME OF THE MEDICINE: CALCIPOTRIOL
Chemical structure of calcipotriol
Chemical name: (1S, 3R, 5Z, 7E, 22E, 24S) -24-Cyclopropyl-9,
10-secochola-5,7,10(19), 22-
tetraene-1,3,24-triol. CAS 112965-21-6
DESCRIPTION
Calcipotriol is a white or almost white crystalline substance. It is
freely soluble in ethanol,
soluble in chloroform and propylene glycol, particularly insoluble in
liquid paraffin. Solubility in
water is 0.6
m
g/mL and the melting point is 166 – 168ºC. Calcipotriol is a
vitamin D derivative
and behaves in a similar manner to vitamin D, forming a reversible
temperature-dependent
equilibrium between calcipotriol and pre-calcipotriol.
DAIVONEX
®
Ointment contains the anhydrous form of calcipotriol. It also contains
dl-
Į
-
tocopherol, disodium edetate, sodium phosphate - dibasic dihydrate,
purified water, liquid
paraffin, steareth-2, propylene glycol and soft white paraffin.
PHARMACOLOGY
Calcipotriol is a non-steroidal antipsoriatic agent, derived from
vitamin D. Calcipotriol exhibits a
vitamin D-like effect by competing for the 1,25(OH)
2
D
3
receptor. Calcipotriol is as potent as
1,25(OH)
2
D
3
, the naturally occurring active form of vitamin D, in regulating cell
proliferation and
cell differentiation, but much less active than 1,25(OH)
2
D
3
in its effect on calcium metabolism.
Calcipotriol induces differentiation and suppresses proliferation
(without any evidence of a
cytotoxic effect) of keratinocytes, thus reversing the abnormal
keratinocyte changes in psoriasis.
The therapeutic goal envisaged with calcipotriol is thus a
normalisation of epidermal growth.
Pharmacokinetics:
Pharmacokinetic studies with
3
H-calcipotriol have been performed in rats and minipigs. Oral
absorption of calcipotriol was approximately 60% in rats and 40% in
minipigs. The half-life of
calcipotriol was 12 minutes in rats and 60 minutes in minipigs. The
major metabolite of
calcipotriol, MC1080, was present in the first plasma samp