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Logo NERISONE

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

NERISONE
CREAM, OINTMENT,
FATTY OINTMENT

Corticoid skin preparations

COMPOSITION
1 g Nerisone contains
diflucortolone valerate (6alpha,9-difluoro-11beta-hydroxy-21-valeryloxy-16alpha-methyl-1,4-pregnadiene-3,20-dione) 1 mg. The cream contains methylparaben 0,07% and propylparaben 0,03%.

PHARMACOLOGICAL CLASSIFICATION
A. 13.4.1 Corticosteroids without anti-infective agents.

PHARMACOLOGICAL ACTION
Diflucortolone valerate is an effective corticoid. On topical application it suppresses inflammation in inflammatory and allergic skin conditions and ameliorates the subjective complaints, such as itching, burning and pain. Diflucortolone valerate is incorporated in three bases formulated to suit the respective skin condition.

INDICATIONS
All skin diseases which respond to topical corticoid therapy, eg contact dermatitis, contact eczema, occupational eczema; vulgar, nummular (microbial), degenerative and seborrhoeic eczema; dyshidrotic eczema; eczema in varicose syndrome (excluding ulcers); anal eczema; eczema in children; neurodermatitis (endogenous eczema, atopic dermatitis); psoriasis; lichen ruber planus et verrucosus; lupus erythematosus; first degree burns, sunburn, insect bites.

CONTRA-INDICATIONS
Tuberculous and syphilitic processes in the area to be treated, virus diseases (herpes simplex, vaccinia, varicella and smallpox).
Potent topical corticosteroid preparations (Nerisone) should not be applied to any skin crease areas.
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 Nerisone should not be used during pregnancy.

DOSAGE AND DIRECTIONS FOR USE
Unless otherwise prescribed by the doctor, the Nerisone preparation best suited to the skin condition is applied thinly twice or, perhaps, three times per day. Once the clinical picture has improved, one application per day usually suffices. Babies and children up to the age of 4 years should not be treated with Nerisone for longer than three weeks at the most - particularly not in the skin areas covered by nappies.
Nerisone is available in three forms: Nerisone cream, Nerisone ointment and Nerisone fatty ointment. The form to be used in the individual case will depend on the appearance of the skin: Nerisone cream in weeping skin conditions, Nerisone ointment in skin conditions which are neither weeping nor very dry, and Nerisone fatty ointment in very dry skin conditions.
Nerisone cream
Nerisone cream is a highly aqueous and non-greasy preparation. In weeping skin conditions and moist areas of the skin it allows the secretions to drain away, thus providing for rapid subsidence and drying up of the skin. The cream is also suitable for use on exposed body areas (eg the face and the hands) and on hairy areas.
Should Nerisone cream dry out the skin, Nerisone ointment or Nerisone fatty ointment, which contain more fat, should be used.
Nerisone ointment
Skin conditions which are neither weeping nor very dry require a base with balanced proportions of fat and water. Nerisone ointment makes the skin slightly greasy without retaining heat or fluid. Of the three different forms of Nerisone, the ointment has the widest range of use.
Nerisone fatty ointment
Very dry skin conditions and chronic stages demand an anhydrous fatty base. The occlusive effect of the Nerisone fatty ointment base promotes the healing process.
Occlusive dressings
An occlusive dressing may be called for in unusually refractory cases. When it is, it should be managed as follows:
After application of the Nerisone preparation which the doctor considers to be appropriate, the area under treatment should be completely covered with a water-tight dressing which should then be fixed firmly all round to healthy skin by means of adhesive plaster. Plastic gloves can be used to occlude the hands. The dressing should be kept in place for as long as can be expected of the patient, but generally not for longer than 24 hours. If the occlusive treatment is expected to be prolonged, it is advisable to change the dressing every 12 hours. If an infection develops under the dressing, occlusive treatment must be terminated.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Long-term continuous 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, dilatation 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; when potent topical corticosteroids are used 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.
If a secondary microbial skin infection is present suitable concomitant anti-microbial therapy should be instituted. If fungal infections are present, a topically active antimycotic should be applied.
Topical corticosteroids should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacealike facies may be produced.
Topical corticosteroid preparations should be used with caution near the eyes.
Potent topical corticosteroids should be used for short courses only. Regular review should be made of the necessity for continuing therapy.
These corticosteroid preparations should not be used in the nappy areas of infants for flexural eruptions and ideally they should not be used for infants and young children at all.
The treatment of psoriasis with potent topical corticosteroids may provoke the pustular form of the disease.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Please refer to the paragraph "Side effects and special precautions". If any symptoms of overdosage should occur, treatment must be discontinued.

IDENTIFICATION
Nerisone cream: White cream.
Nerisone ointment: White to yellowish-white ointment.
Nerisone fatty ointment: White to yellowish-white fatty ointment.

PRESENTATION
Tubes with 15 g and 30 g.

STORAGE INSTRUCTIONS
Store below 30°C. Keep out of reach of children.

REGISTRATION NUMBER
Nerisone cream:         H/13.4.1/218
Nerisone ointment:         H/13.4.1/219
Nerisone fatty ointment:         H/13.4.1/220

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
Nerisone cream: 01.06.1976
Nerisone ointment and fatty ointment: 12.03.1976

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry

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