COMPOSITION: Each gram contains: Miconazole nitrate 20 mg Triamcinolone acetonide 1 mg Neomycin sulphate 2,5 mg
in a cream formulation with benzoic acid 0,2% m/m as a preservative.
PHARMACOLOGICAL CLASSIFICATION: A.13.4.1 Dermatological Preparations. Corticosteroids with or without anti-infective agents.
PHARMACOLOGICAL ACTION: Triamcinolone acetonide is a synthetic corticosteroid which, applied to the skin, has a more potent local anti-inflammatory action than hydrocortisone.
Miconazole nitrate is an imidazole derivative of high potency against a wide range of commonly encountered fungi and possesses some anti bacterial activity.
Neomycin sulphate is an aminoglycoside antibiotic with a spectrum of activity against staphylococci, streptococci and a wide range of Gram-negative bacteria, including E. coli.
INDICATIONS: TRIALONE cream is indicated for the treatment of steroid responsive dermatoses which are complicated by miconazole susceptible fungi and neomycin susceptible bacteria.
CONTRA-INDICATIONS: TRIALONE cream is contra-indicated in the treatment of herpes simplex, vaccinia or varicella.
WARNINGS: The potent topical corticosteroid preparation TRIALONE cream should not be applied to any skin crease areas.
DOSAGE AND DIRECTIONS FOR USE: TRIALONE cream should be gently rubbed into the affected areas of the skin twice daily until ten days after the lesions have disappeared.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: TRIALONE cream is well tolerated. Local sensitivity reactions due to the miconazole and neomycin components may occur, whilst burning and itching due to miconazole have been reported.
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, dilation of superficial blood vessels, telangiectasias 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 (HPA) 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.
TRIALONE cream must be used for short courses of treatment only. Regular review should be made of the necessity for continuing therapy.
TRIALONE cream should be used with particular caution in facial dermatoses and in the flexural eruptions and only for short periods. A steroid rosacea-like facies may be produced.
TRIALONE cream should be used with caution near the eyes.
TRIALONE cream should not be used in the nappy areas in infants for flexural eruptions and ideally it should not be given to infants and young children at all.
The treatment of psoriasis with TRIALONE may provoke the pustular form of the disease.
Not more than 50 g weekly of triamcinolone-base must be given without assessment of HPA function.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Ingestion of the amounts of the components contained in a tube of cream are unlikely to produce overdosage and toxic effects.
IDENTIFICATION: A smooth, white, water-miscible cream.
PRESENTATION: TRIALONE cream is supplied in a tube containing 15 g of cream.
STORAGE INSTRUCTIONS: Store below 25°C.
Keep out of reach of children.
REGISTRATION NUMBER: K/13.4.1/302.
NAME AND BUSINESS ADDRESS OF THE APPLICANT: JANSSEN
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 80/11122/07)