(and dosage form):
1 g Nerisone Forte contains diflucortolone valerate (6alpha,9-difluoro-11beta-hydroxy-21-valeryloxy-16alpha-methyl-1,4-pregnadiene-3,20-dione) 3 mg (0,3%).
A. 13.4.1 Corticosteroids without anti-infective agents.
Nerisone Forte is a preparation of diflucortolone valerate. Nerisone Forte suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints, such as itching, burning and pain.
Psoriasis vulgaris, neurodermatitis, eczema, lichen ruber planus et verrucosus (pityriasis rubra pilarus), erythematodes chronicus discoides (discoid lupus erythematosus), severe conditions of chronic eczema.
Tuberculous and syphilitic processes in the area to be treated, virus diseases (herpes simplex, vaccinia, varicella and smallpox).
The preparations should never be applied to the face or 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 Forte should not be used during pregnancy.
DOSAGE AND DIRECTIONS FOR USE
Nerisone Forte ointment and fatty ointment must not be used for periods exceeding 2 weeks. Unless otherwise prescribed, Nerisone Forte is applied thinly twice a day. For further treatment, a switch should be made to a less potent topical corticosteroid preparation.
Nerisone Forte is available in two bases: Nerisone Forte ointment and Nerisone Forte fatty ointment. Which form should be used in the individual case will depend on the appearance of the skin: Nerisone Forte ointment in skin conditions which are neither weeping nor very dry; Nerisone Forte fatty ointment in very dry skin conditions.
Nerisone Forte ointment has a base with balanced proportions of water and fat. It makes the skin slightly greasy.
Nerisone Forte fatty ointment has an anhydrous fatty base.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Infants and children up to the age of 4 years should not be treated with Nerisone Forte.
The preparations should never be applied to the face. Contact with the eyes must be avoided.
Long-term continuous treatment with Nerisone Forte 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 the topically applied corticosteroid 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.
If a secondary microbial skin infection is present suitable concomitant anti-microbial therapy should be instituted. If fungal infections are present, a topically active anti-mycotic should be applied.
Nerisone Forte should be used for short courses only.
Regular review should be made of the necessity for continuing therapy.
The treatment of psoriasis with Nerisone Forte may provoke the pustular form of the disease.
Nerisone Forte fatty ointment should not be applied to weeping foci.
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.
Nerisone Forte ointment: white to yellowish-white ointment.
Nerisone Forte fatty ointment: white to yellowish-white fatty ointment.
Nerisone Forte ointment: tubes of 15 g.
Nerisone Forte fatty ointment: tubes of 15 g and 30 g.
Store below 30°C. Keep out of reach of children.
Nerisone Forte ointment: R/13.4.1/27
Nerisone Forte fatty ointment: R/13.4.1/26
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
P O Box 5278
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
7 January 1986
SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Schering AG Germany
Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry
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