(and dosage form):
Each 5 g of ointment contains 0,0025 g of clobetasol propionate.
A 13.4.1 Dermatological preparations - corticosteroids without anti-infective agents.
Clobetasol propionate is a highly potent topical corticosteroid.
Short term use in the treatment of steroid responsive dermatoses resistant to other less potent topical corticosteroids such as: seborrhoeic dermatitis, atopic dermatitis, lichen simplex chronicus, pruritus ani, psoriasis, later phase of allergic contact dermatitis, later phase of irritant dermatitis, discoid lupus erythematosus and lichen planus.
Dovate ointment should not be used in the presence of bacterial (including tuberculous); fungal or viral infections of the skin.
Application to ulcers of the leg.
Avoid use in ulcerative skin lesions and in rosacea.
Long-term use is contra-indicated in patients with diabetes mellitus or tuberculosis.
The more potent 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, Dovate should not be used during pregnancy.
Known sensitivity to corticosteroids.
FOR EXTERNAL USE ONLY
DOSAGE AND DIRECTIONS FOR USE:
Apply once or twice daily sparingly to the affected area until improvement occurs. Therapy should be discontinued when control is achieved. In the more responsive conditions this may be within a few days. If a longer course is necessary, it is recommended that treatment should not be continued for longer than four weeks without the patients condition being reviewed. Repeated short courses of Dovate may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used.
In very resistant lesions, especially where there is hyperkeratosis, the treatment area may be occluded for part of each 24 hours. Thereafter improvement can usually be maintained by application without occlusion.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dovate may under certain circumstances, be absorbed through the skin in sufficient amounts to produce systemic effects. Systemic absorption may cause suppression of the pituitary-adrenal axis. Even small amounts absorbed may cause growth retardation in children. As Dovate contains a highly potent corticosteroid, the risk associated with systemic absorption is enhanced.
Absorption (and a risk of subsequent toxicity) is also enhanced by application for prolonged periods under occlusive dressings, by application to extensive areas or when the skin is broken.
Once absorbed through the skin the pharmacokinetic pathway is similar to systemically administered corticosteroids. Depression of the hypothalamic pituitary-adrenal-axis with consequent suppression of the adrenal gland may occur.
Topical application of Dovate should not be made with an occlusive dressing to large areas of the body because the increased risk of systemic toxicity.
Application of Dovate to the skin has led to loss of skin collagen and subcutaneous atrophy; local hypopigmentation of deeply pigmented skins has been reported.
In the treatment of severe psoriasis Dovate may induce generalised pustular psoriasis during therapy or on withdrawal.
Other local effects include atrophy of the epidermis and dermal collagen (causing atrophic striae), drying of the skin and telangiectasiae.
Increased fragility of cutaneous vessels may result in bruising and purpura.
Rosacea-like dermatitis, perioral dermatitis and acneiform eruptions may occur.
Occlusive dressings are associated with maceration of the skin and miliaria.
Local infection may be worsened and spread enhanced.
Special care should be exercised in infants and children.
Areas of the body most likely to suffer local damage are the face and eyelids; the intertriginous areas, the neck, axillae, etc. are more permeable. The topical application of Dovate to the eyes has produced corneal ulcers, raised intra-ocular pressure, and reduced visual function.
Long-term topical use is best avoided, especially in children.
Children may absorb proportionally larger amounts of Dovate because of a larger skin surface area to body-mass ratio, and thus be more susceptible to systemic toxicity. Tight-fitting nappies or plastic pants should not be used on an infant being treated in the nappy area, as these garments may constitute occlusive dressings. Depression of the hypothalamic-pituitary-adrenal axis in children may retard growth and development. Benign intracranial hypertension has been reported.
Use with care in porphyrics.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and Special Precautions".
Treatment is supportive and symptomatic.
A soft, smooth, off-white ointment.
Tubes of 25 g
Store below 25°C. Keep tube tightly closed.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
KOHLER C&P P.E
Updated November 2002
Current: September 2004
Source Community Pharmacy
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