QUALITATIVE AND QUANTITATIVE COMPOSITION
% w/w 1.0 Specification BP.
Active Ingredient: Hydrocortisone acetate
4.1 Therapeutic indications Uses: Irritant dermatitis, contact allergic dermatitis, insect bite reactions and eczema (mild to moderate).
4.2 Posology and method of administration For topical application to the skin. Adults, children over 10 and the elderly: Apply sparingly over a small area once/twice a day for a maximum of one week. If the condition does not improve, consult your doctor. Do not use for children under 10 without medical advice.
4.3 Contraindications The product should not be used on the eyes or face, the ano-genital areas or on broken or infected skin including cold sores, acne and athletes foot.
Special warnings and precautions for use
The product labelling will include the following statements: Contains hydrocortisone. If the condition does not improve, consult your doctor. Do not use on the eyes or face, the ano-genital region or on broken or infected skin including cold sores, acne and athletes foot. Do not use in pregnancy without medical advice.
In order to minimise the side-effects of a topical corticosteroid it is important to apply it thinly to affected areas only, no more frequently than twice a day. Upon discontinuation a rebound exacerbation of the condition may occur. This product should not be used under an occlusive dressing or napkin because of the potential for increased absorption of hydrocortisone and subsequent risk of adrenal suppression. In infants and children, long-term continuous topical therapy with hydrocortisone should be avoided where possible, as adrenal suppression can occur even without occlusion. Treatment should be limited to a maximum of seven days. Care should be taken to avoid transfer of product to the eye or periorbital region. Increased intraocular pressure or glaucoma has been reported following use of topical steroids around the eye.
4.5 Interaction with other medicinal products and other forms of interaction None stated.
Fertility, pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Topical administration 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 information about effects on lactation.
4.7 Effects on ability to drive and use machines None stated.
4.8 Undesirable effects Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity, including allergic contact dermatitis or worsening of the original condition appear, treatment should be stopped immediately. Epidermal thinning, telangiectasia and irreversible striae atrophicae may occur in areas of high absorption such as skin folds. Acne or acne rosacea, mild skin pigmentation changes and hypertrichosis may occur after application of topical steroids. Although less likely than with other more potent topical corticosteroids, prolonged use of large amounts, or treatment of extensive areas can result in sufficient systemic absorption to produce suppression of the hypothalamic-pituitary- adrenal axis and the clinical features of Cushings syndrome. These effects are more likely to occur in infants and children and if occlusive dressings are used (see section 4.4). In infants the napkin may act as an occlusive dressing.
4.9 Overdose Acute overdose is very unlikely to occur. However, chronic overdose or misuse may result in increased risk of topical or systemic steroid-related adverse effects, including Cushings syndrome. Topical steroids should be discontinued gradually under medical supervision.
5.1 Pharmacodynamic properties Hydrocortisone Hydrocortisone is a well-known, well documented pharmacopoeial substance and therefore no further information is given here.
5.2 Pharmacokinetic properties Hydrocortisone Hydrocortisone is a well-known, well documented pharmacopoeial substance and therefore no further information is given here.
5.3 Preclinical safety data No preclinical findings of relevance have been reported.
6.1 List of excipients Cetearyl alcohol and ceteareth-20 blend (Promulgen D), cetyl alcohol, sorbitol solution 70%, propyl paraben, methyl paraben, purified water, Roure Bertrand Dupont H3170 fragrance and zinc pyrithione 40% dispersion.
6.2 Incompatibilities None stated.
6.3 Shelf life Four years.
6.4 Special precautions for storage None stated.
6.5 Nature and contents of container A decorated unlined aluminium tube with cap packed into a cardboard carton. Quantity: 15g.
6.6 Special precautions for disposal For topical application to the skin.
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd Slough SL1 4AQ
MARKETING AUTHORISATION NUMBER(S)
1st October 1992.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT