(and dosage form):
Each 5 g contains 6 mg betamethasone valerate equivalent to 5 mg betamethasone.
Methyl hydroxybenzoate 0,2% m/m
Propyl hydroxybenzoate 0,02% m/m
A. 13.4.1Corticosteroids with or without anti-infective agents.
Betamethasone valerate is a potent topical corticosteroid which exhibits anti-inflammatory and anti-allergic properties when applied to the skin and mucosa. The mechanism of action is related to causing vasoconstriction, stabilising lysosomal membranes, suppressing cell division and suppressing the immune response.
Non-infected steroid responsive dermatoses.
Hypersensitivity to any of the ingredients.
Rosacea, acne, peri-oral dermatitis, tuberculosis of the skin and varicose ulcers. Skin lesions caused by infection with viruses (e.g. herpes simplex) vaccinia or varicella), Fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo).
ADCO-BETAMETHASONE must not be used in the nappy areas of infants for flexural eruptions. Betamethasone valerate should not be used in acute infections. Corticosteroids have shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore ADCO-BETAMETHASONE must not be used during pregnancy. Betamethasone should not be used to treat infections and ulcers of the leg. It causes delayed wound healing and increased liability to infections.
For external use only.
DOSAGE AND DIRECTIONS FOR USE:
Apply to the affected areas 1 to 3 times daily by gentle inunction.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local effects include subcutaneous atrophy, loss of skin collagen (atrophic striae), drying and thinning of the skin, loss of elasticity, dilatation of superficial blood vessels, telangiectasis and ecchymoses. Increased fragility of cutaneous vessels may result in bruising and purpura. Rosacea- like dermatitis, perioral dermatitis, hypopigmentation and acne-form eruptions occur. These changes are particularly likely to occur on the face, and when occlusive dressings are used and absorption increased up to ten fold, or where skinfolds are involved.
Systemic absorption of topically applied Betamethasone may occur, particularly under the following conditions: when large quantities are used, when application is made to wide areas of the body or to damaged skin and when the occlusive dressing technique is applied. This may result in depression of the hypothalmic pituitary-adrenal axis with consequent supression of the adrenal gland. These effects are most likely to be severe in children. Growth retardation in children has been reported and a Cushingoid state may be produced. Benign intracranial hypertension has been reported.
The use of steroids during pregnancy is not recommended. Topical application should not be made with occlusive dressing to large areas of the body because of the increased risk of systemic toxicity and should not in general be used in the presence of infection. Treatment should be discontinued if unfavourable reactions are seen. Regular review should be made of the necessity for continuing therapy. If a secondary microbial skin infection is present, suitable concomitant antimicrobial therapy should be instituted. ADCO-BETAMETHASONE should be used with caution near the eyes; application to the eyes has produced increase intraocular pressure, reduced visual function and corneal ulcers. Treatment of (or withdrawal) Betamethasone in psoriasis may provoke the pustular form of the disease ADCO-BETAMETHASONE should not be used in infants or small children. Long-term topical use is best avoided, especially in children.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See "side effects and special precautions". Treatment is supportive and symptomatic and consists of discontinuation of topical therapy , gradual withdrawal of the preparation or reduction in dosage.
A white cream.
15 g and 30 g aluminium tubes.
Store below 25°C. Keep well-closed. Protect from light. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26 July 1996
New addition to this site: April 2004
Source: Pharmaceutical Industry
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