Hydrocortisone 1.0% Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efcortelan Cream 1%
Hydrocortisone 1% Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone BP 1% W/W.
3 PHARMACEUTICAL FORM
Aqueous Cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Hydrocortisone has topical anti-inflammatory activities of value in the treatment of a wide variety of dermatological conditions, including the following: eczema, including atopic, infantile, discoid and stasis eczemas: prurigo nodularis, neurodermatoses, seborrhoeic dermatitis, intertrigo and contact sensitivity reactions.
Hydrocortisone preparations can also be used in the management of insect bites and otitis externa.
Hydrocortisone 0.5% preparations can be used as continuation therapy in mild cases of seborrhoeic or atopic eczema once the acute inflammatory phase has passed.
4.2 Posology and method of administration
Adults, children and elderly
A small quantity should be applied to the affected area two or three times daily.
Hydrocortisone cream is often appropriate for moist or weeping surfaces, and Hydrocortisone ointment for dry-lichenified or scaly lesions, but this is not invariably so.
For topical application.
4.3 Contraindications
Skin lesions caused by infection with viruses (e.g. herpes simplex, chicken pox), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo). Hypersensitivity to the preparation.
4.4 Special warnings and precautions for use
In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur even without occlusion. In infants, the napkin may act as an occlusive dressing, and increase absorption. Treatment should therefore be limited, if possible, to a maximum of 7 days.
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.
As with all corticosteroids, prolonged application to the face is undesirable.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Topical application of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Hydrocortisone preparations are usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately.
Local atrophic changes may occur where skin folds are involved, or in areas such as the nappy area in small children, where constant moist conditions favour the absorption of hydrocortisone. Sufficient systemic absorption may also occur in such sites to produce the features of hypercorticism and suppression of the HPA axis after prolonged treatment.
The effect is more likely to occur in infants and children, and if occlusive dressings are used.
There are reports of pigmentation changes and hypertrichosis with topical steroids. Exacerbation of symptoms may occur.
Reporting of suspected adverse reactions
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects which suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.
5.2 Pharmacokinetic properties
Hydrocortisone is absorbed through the skin particularly in denuded areas. Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
BP
BP
BP
BP
BP
Chlorocresol
Cetomacrogol 1000 Cetostearyl alcohol
White Soft Paraffin
Liquid Paraffin
|
Sodium Acid Phosphate |
BP |
|
Phosphoric Acid |
BP |
|
Sodium Hydroxide |
BP |
|
Purified Water |
BP |
|
Incompatibilities |
None known.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Store below 25°C
6.5 Nature and contents of container
15gm, 30gm and 50gm collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a wadless polypropylene cap.
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
CHEMIDEX PHARMA LIMITED T/A ESSENTIAL GENERICS
CHEMIDEX HOUSE, UNIT 7, EGHAM BUSINESS VILLAGE
CRABTREE ROAD
EGHAM
SURREY
TW20 8RB
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 17736/0091
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18 December 1997 / October 04.
10 DATE OF REVISION OF THE TEXT
08/08/2014