INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DOVONEX Cream
DOVONEX Ointment
DOVONEX Scalp Solution

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

DOVONEX Cream
DOVONEX Ointment
DOVONEX Scalp Solution

COMPOSITION:
Each gram of cream contains:
Calcipotriol hydrate equivalent to
Calcipotriol (anhydrous)
        50 micrograms
Preservatives: 
Chloroallylhexaminium chloride 0,05% m/m
Disodium edetate 0,05%m/m
Each gram of ointment contains:        
Calcipotriol (anhydrous)         50 micrograms.
Each mL of scalp solution contains:        
Calcipotriol hydrate equivalent to
Calcipotriol (anhydrous)
        50 micrograms.

PHARMACOLOGICAL CLASSIFICATION:
A 13. 9.1 Preparations for psoriasis

PHARMACOLOGICAL ACTION:
Calcipotriol is a Vitamin D analogue. Topical application will induce differentiation and suppress proliferation of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis.
Studies in psoriatic patients demonstrate less than 1% absorption of the applied dose.

INDICATIONS:
DOVONEX Cream
and Ointment are indicated for the topical treatment of psoriasis vulgaris, mainly plaque psoriasis. DOVONEX Scalp Solution is indicated for the topical treatment of scalp psoriasis.

CONTRA-INDICATIONS:
Hypersensitivity to any of the constituents.
Hypercalcaemia.
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
DOVONEX Cream and Ointment:
Adults:- Apply a thin layer twice daily to the affected areas, and rub in lightly. After satisfactory improvement has occurred (usually 4 - 8 weeks), the treatment may be discontinued. Maximum weekly dose should not exceed 100 g of cream or ointment.
Children:- Dosage in children has not been established.

DOVONEX Scalp Solution:
Adults:- Apply twice daily (morning and evening). Apply a few drops to the affected skin on the scalp and rub in lightly. Maximum weekly dose should not exceed 60 mL.
When used together with DOVONEX Cream or Ointment, the total dose of calcipotriol should not exceed 5 mg/week (corresponding to e.g. 60 mL DOVONEX Scalp Solution plus 40 g of the ointment/cream).
Children: - Not recommended as there is no experience of the use of DOVONEX Scalp Solution in children.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local irritation may occur after application of the cream or ointment.
The following side-effects have been reported with the scalp solution: burning, stinging, tingling and a rash. Local irritation on the scalp and face may occur after application.
DOVONEX should not be applied to the face since this may give rise to itching and erythema. Patients should be advised to wash their hands after application and to avoid inadvertent transfer to the face and other body areas.
No interaction has been found between DOVONEX and sunlight or UV light. The use of concomitant therapy with other antipsoriatic treatments applied to the same skin areas has not been established.
Where extensive application is required for prolonged periods, it is advisable to monitor serum calcium levels at regular intervals.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Use above the recommended dose may cause elevated serum calcium which rapidly subsides when treatment is discontinued.
Treatment is supportive and symptomatic.

IDENTIFICATION:
DOVONEX Cream
: Soft, white cream.
DOVONEX Ointment: Faint translucent white to yellowish ointment.
DOVONEX Scalp Solution: Clear, colourless, slightly viscous solution.

PRESENTATION:
DOVONEX Cream
and Ointment: Aluminium tubes containing 30g or 100g.
DOVONEX Scalp Solution: White polyethylene bottles with nozzles and screw caps, containing either 30 mL or 60 mL of solution.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.
Caution:
DOVONEX Scalp Solution is flammable - keep away from fire or flames.

REGISTRATION NUMBER:
DOVONEX Cream:         29/13.9.1/0270
DOVONEX Ointment:         Z/13.9.1/207
DOVONEX Scalp Solution:         29/13.9.1/0762

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Ave
Bryanston
Private Bag X69
Bryanston
2021

Under licence from:
LEO PHARMACEUTICAL PRODUCTS
Ballerup
DENMARK

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
29 July 1996

New addition to this site: April 2004
Source: Pharmaceutical Industry

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