DILUCORT CREAM; DILUCORT OINTMENT

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

DILUCORT CREAM
DILUCORT OINTMENT

SCHEDULE STATUS:
S2

PROPRIETARY NAME
(and dosage form):

DILUCORT CREAM
DILUCORT OINTMENT

COMPOSITION:

Cream:	0,5 g Hydrocortisone Acetate in 100 g of water dispersible cream - contains 0,1% Chlorocresol as preservative.
Ointment	0,5 g Hydrocortisone Acetate in 100 g ointment base.

PHARMACOLOGICAL CLASSIFICATION:
A 13.4.1 Corticosteroid without anti-infective agent

PHARMACOLOGICAL ACTION:
Hydrocortisone has anti-inflammatory, anti-pruritic, anti-allergic and vasoconstrictive effects.

INDICATIONS:
For the temporary relief of itching associated with minor skin irritations due to eczema, insect bites, poison plants, soaps, detergents, cosmetics, jewellery, seborrhoeic dermatitis and for the relief of external genital and anal itching. Other uses for this product should be only under the advice and supervision of a doctor.

CONTRA-INDICATIONS:
Do not use in the presence of vaginal discharge. Consult a doctor.
Do not use this product for cosmetic purposes. Do not use this product for nappy rash.
In the event of external anal itching accompanied by bleeding consult a doctor immediately.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
This product may not be used for the indications pertaining to the genital and anal use in children under the age of 12 years. Consult a doctor.
Do not use this product for longer than 7 days; do not use in the presence of bacterial, fungal or viral infections; do not use in children under the age of 2 years; do not exceed the recommended dose.
Corticosteroids have been shown to be teratogenic in animals following dermal application.
As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded.
Therefore Dilucort should not be used during pregnancy.

WARNINGS:

Do not use this product for cosmetic purposes.

For external use only. Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and consult a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Hydrocortisone should be applied to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Long-term treatment with topical corticosteroids should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasiae and ecchymoses. These changes are particularly likely to occur on the face and when occlusive dressings are used.
Systemic absorption of topically applied corticosteroids may occur, particularly under the following conditions: when large quantities are used; or when application is made to wide areas of the body; or to damaged skin; and when the occlusive dressing technique is applied. Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur.
These effects are most likely to be severe in children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been rarely reported.
The following special precautions are recommended:
If a secondary microbial skin infection is present, suitable concomitant antimicrobial therapy should be instituted.
Topical corticosteroids should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced.
Topical corticosteroid preparations should be used with caution near the eyes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is supportive and symptomatic.

IDENTIFICATION:

Dilucort Cream:	A smooth white cream.
Dilucort Ointment:	A smooth off-white ointment.

PRESENTATION:
Cream and ointment. Tubes of 25 g and jars containing 400 g.

STORAGE INSTRUCTIONS:
Store below 25°C in well-closed containers. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

Cream:	R/13.4.1/21
Ointment:	R/13.4.1/20

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Triomed (Pty) Ltd, Building No 3, Parc Du Cap
Cnr. Mispel Road and Willie van Schoor Road
Bellville 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

16/08/1993	K850
	Tradepak PE