Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co Tipperary, Ireland
Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.
Use in acne vulgaris, acne rosacea or in perioral dermatoses.
Side effects include local irritation, hypersensitivity and intercurrent infections.
Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression or of growth suppression.
Prolonged use of uninterrupted occlusion or use with extensive occlusive dressings including napkin may suppress adrenocortical function.
Continuous application without interruption will result in local atrophy of the skin, striae and superficial vascular dilatation, particularly on the face.
There have been a few reports in the literature of the development of cataracts in patients who have been using corticosteroids for prolonged periods of time. Although it is not possible to rule out co-administered systemic corticosteroids as a known factor, prescribers should be aware of the possible role of corticosteroids in cataract development.
None known.
This product should not be used in pregnancy unless considered essential by the physician.
Topical administrations of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
There is no evidence against use in lactating women. However caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area.
Not applicable.
Rarely, local sensitivity may occur, requiring discontinuation of treatment.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: http://www.hpra.ie/; E-mail: medsafety@hpra.ie.
Not applicable.
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