(and dosage form):
Each 1g contains:
|| 10 mg|
|| 01% m/m|
A. 13.4.1 Dermatological preparations. Corticosteriods with or without anti-infective agents.
BIOCORT has anti-inflammatory, antipruritic and vasoconstrictive properties.
For the relief of symptoms of corticosteroid-responsive dermatoses.
Sensitivity to any of the ingredients.
Treatment of local viral infection such as herpes simplex, vaccinia or varicella (an acute exacerbation or systemic dissemination of these infections may be precipitated).
Should not be used in nappy areas in infants for flexural eruptions and ideally should not be used in infants or young children at all.
Cortisteroids 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 BIOCORT should not be used during pregnancy. Do not apply to ulcers of the leg. Do not use in treatment of rosacea. (3)
FOR EXTERNAL USE ONLY.
Topical applications of corticosteroids should not be made with an occlusive dressing, to large areas of the body, or where the skin is broken because of the increased risk of systemic toxicity.
Topical corticosteroids should in general not be used in the presence of infection. However occasionally they may be used with the addition of a suitable antimicrobial substance in the treatment of infected skin, but there is a risk of sensitivity reactions occurring.
DOSAGE AND DIRECTIONS FOR USE:
After thorough cleaning of the affected skin, a thin layer of cream is applied and rubbed gently into the affected area. Application may be made one to three times daily.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Mild pigmentation may also occur. Acne spots may also occur at the site of application. The continuous use of BIOCORT may result in atrophic changes in the skin leading to thinning loss of elasticity, striae, dilation of superficial blood vessels, telangiectasiae and ecchymoses. These changes are particularly likely to occur in areas of the greatest permeability such as the face, eyelids, axillae and scrotum and possibly the groin. Mild depigmentation may also occur.
Acne spots may occur at the site of application. Allergic contact dermatitis may be produced. Systemic absorption is likely to occur when application is made to large areas of the body, or to damaged skin and when the occulsive dressing technique is applied. Tight-fitting nappies or plastic pants should not be used on an infant being treated in the nappy areas, as these germents may constitute as occlusive dressings.
Depression of the hypothalamic-pituitary-adrenal (HPA)-axis, with consequent supression of the adrenal gland may occur. Children may absorb propotionally large amounts of topical corticosterids and thus be more susceptible to systemic toxicity.
Depression of the HPA-axis in children may retard growth and development in children. Benign intracranial hypertension has been reported. Cushing's syndrome may develop as a result of continued and excessive absorption of BIOCORT, but this complication is very infrequent.
Patients undergoing stress such as major surgery or severe infection, septicaemia, trauma e.g. a motor vehicle accident, should receive replacement therapy to prevent a possible adrenal crisis. The real incidence of such a crisis after the use of BIOCORT is not known, it is presumably uncommon.
BIOCORT should be used with particular caution in facial dermatoses.
Special caution should be exercised in using BIOCORT near the eyes.
BIOCORT should be used for short treatment courses only. Long term topical use is best avoided, especially in children.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and special precautions.
Treatment of overdosage is symptomatic and supportive.
White to off-white cream.
20g and 25g tubes and 500g jars.
Store below 25°C, protected for light.
KEEP OUT OF REACH OF CHILDREN.
G 2022 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF APPLICANT:
ADCOCK INGRAM LTD.
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: April 2005
Source: Hospital Pharmacy
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