(and dosage form):
with a corticoid additive
1 g Travocort contains isoconazole nitrate (1-[2,4-dichloro-b-(2,6-dichlorobenzyloxy)-phenethyl]-imidazole, nitrate) 10 mg and diflucortolone valerate (6alpha,9-difluoro-11beta-hydroxy-21-valeryloxy-16alpha-methyl-1,4-pregna- diene-3,20-dione) 1 mg in an easy-to-remove low fat base o/w emulsion.
A. 13.4.1 Corticosteroids with anti-infective agents.
Isoconazole nitrate is for use in the treatment of superficial fungal diseases of the skin. It is effective against dermatophytes and yeasts, yeast-like fungi and moulds, as well as against the causative organism of tinea versicolor and that of erythrasma.
Diflucortolone valerate suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints such as itching, burning and pain.
Fungal infections of hairless and hairy skin, eg in the region of the hands, the interdigital spaces of the feet, and in the inguinal and genital regions.
Because of the addition of diflucortolone valerate, Travocort is indicated for the initial or intermediate treatment of those fungal diseases which are accompanied by highly inflammatory or eczematous skin conditions.
Tuberculous and syphilitic processes in the area to be treated, virus diseases (herpes simplex, vaccinia, varicella and smallpox).
Potent topical corticosteroid preparations (Travocort) 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 Travocort should not be used during pregnancy.
DOSAGE AND DIRECTIONS FOR USE
Unless otherwise instructed, Travocort should be applied twice daily to the diseased areas of skin. In infections of the interdigital spaces it is often advisable to place a strip of gauze smeared with Travocort between the toes or fingers.
The treatment with Travocort must be terminated after regression of the inflammatory or eczematous skin condition and the therapy continued or followed up with the isoconazole nitrate preparation without corticoid additive. This applies in particular for use in inguinal and genital regions.
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.
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.
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
With overdosage, the symptoms described under "Side effects and special precautions" may occur. Treatment should be discontinued.
White to slightly yellowish cream.
Tubes of 20 g.
Store below 25°C. Keep out of reach of children.
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
16 November 1981
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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