(and dosage form):
REPIVATE CREAM contains in each 15g betamethasone 1.5 mg as the valerate.
Preservative: Methyl Paraben 0,12% m/m and Probyl paraben 0,04% m/m
A 13.4.1. Dermatological preparation - corticosteroid without anti-infective agents.
REPIVATE is a topical corticosteroid which exhibits anti-inflammatory and anti-allergic properties when applied to the skin.
Non-infected steroid responsive dermatoses.
Hypersensitivity to any of the ingredients. Topical corticosteroid preparations are contra-indicated in the treatment of herpes simplex, vaccinia or varicella and tuberculosis of the skin. Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents of absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore REPIVATE should not be used during pregnancy.
REPIVATE should not be used on infants and young children. REPIVATE should not be used to treat infections and leg ulcers as it causes delayed wound healing and increased liability to infections.
DOSAGE AND DIRECTIONS FOR USE:
Apply in a small quantity to the affected area 2 or 3 times daily. REPIVATE should be used for short courses only.
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. Increased fragility of cutaneous vessels may result in bruising and purpura. These changes of particular the likely to occur on the face and when occlusive dressings are used. Systemic absorption of topically applied REPIVATE may occur; particularly under the following conditions: When large quantities are used, when application is made to wide areas of the body, or to damage skin and when occlusive dressing technique is applied. Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur and may be precipitated by an infection or trauma. These effects on most likely to be severe in children. Growth retardation has been reported and a Cushingoid state may be produced. Benign intracranial hypertension has been reported.
If unfavourable reactions occur treatment should be discontinued. If secondary microbial skin infection is present suitable, concomitant anti-microbial therapy should be instituted. REPIVATE should be used with particular caution in facial dermatoses, and only for short periods. REPIVATE should be used with caution near the eyes. Application to the eyelids has caused raised intraocular pressure, corneal ulcers, and reduced visual function. The treatment of psoriasis with REPIVATE may provoke the pustural form of the disease. Regular review should be made of the necessity for continuing therapy.
REPIVATE should not be applied to any skin crease areas.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions".
Treatment is supportive and symptomatic.
A white cream with no visible foreign particles. When rubbed onto the skin it spreads easily and is non greasy.
15g aluminium tube or 500g plastic jar.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
Xeragen Laboratories (Pty) Ltd.
Units 8-11 Glen Park Industrial
1 Highdale Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: March 2004
Source: Pharmaceutical Industry
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