Hydrocortisone Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Ointment BP 0.5%
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 0.50% w/w Hydrocortisone PhEur.
3. PHARMACEUTICAL FORM
A white ointment.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Hydrocortisone has topical anti-inflammatory activities of value in the treatment of various dermatological conditions including:
Eczema- atopic, infantile, discoid or stasis
Dermatitis- primary irritant, contact allergic, photo or seborrhoeic
Insect bite reactions
Prurigo nodularis
Neurodermatoses
Otitis externa
Intertrigo
Napkin rash, where concurrent infection is excluded or being addressed
Hydrocortisone Ointment 0.5% 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
Posology
Adults (including elderly)
Gently apply a thin layer of ointment to the affected area two or three times daily.
Children and infants
Gently apply a thin layer of ointment to the affected area two or three times daily. Avoid prolonged use. In infants, therapy should be limited to five to seven days.
Hydrocortisone ointment should be considered for dry, scaly or lichenified conditions whereas the cream formulation is usually suitable for moist or weeping surfaces.
Method of Administration For topical application.
4.3. Contra-Indications
Hypersensitivity to hydrocortisone or any of the other ingredients in the product.
Untreated bacterial (e.g. impetigo), viral (e.g. herpes simplex), or fungal (e.g. candida or dermatophyte) infections.
Scabetic infections.
Rosacea.
Perioral dermatitis.
4.4. Special warnings and precautions for use
If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially in children.
In infants and children, long-term continuous topical therapy should be avoided, as adrenal suppression can occur, even without occlusion.
Extreme caution is required in dermatoses of infancy, including napkin rash. In infants, the napkin may act as an occlusive dressing, and increase absorption. Treatment in infants should therefore be limited to five to seven 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.
Keep away from the eyes.
4.5. Interaction with other medicinal products and other forms of interaction
No interactions have been reported for topical hydrocortisone.
4.6. Pregnancy and Lactation
There is inadequate evidence of safety in human pregnancy. Topical administration of topical 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.
4.7. Effects on ability to drive and use machines
Hydrocortisone does not affect the ability to drive and use machines.
4.8. Undesirable effects
Discontinue treatment should sensitisation occur.
Application to skin folds and moist areas, or in nappy areas in young children, may cause local atrophic changes where constant moist conditions favour the absorption of hydrocortisone. Sufficient systemic absorption may occur which may lead to suppression of the HPA (hypothalamic pituitary adrenal) axis after prolonged treatment. This effect is more likely to occur in infants and children, and if occlusive dressings are used.
Changes in skin pigmentation and hypertrichosis may occur. Contact dermatitis may also occur.
4.9. Overdose
Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage, use under occlusive dressings or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
There are no special procedures or antidote. Treat any adverse effects symptomatically.
5.1. Pharmacodynamic Properties
ATC Code: D07 AA02
Pharmacotherapeutic group: Weak dermatological corticosteroid (group 1).
Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects, mediated by the reduction of formation, release and action of the various vasoactive chemicals released during inflammation. Thus producing suppression of the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.
5.2. Pharmacokinetic Properties
Absorption
Hydrocortisone is absorbed through skin, particularly in denuded areas. Distribution
Corticosteroids are rapidly distributed to all body tissues. They cross the placenta to varying degrees and may be excreted in small amounts in breast milk. Corticosteroids in the circulation are usually extensively bound to plasma proteins, mainly to globulin and less so to albumin.
Metabolism
Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol.
Excretion
The metabolites are excreted in the urine mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.
5.3. Pre-clinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6.1. List of Excipients
Also contains: paraffin.
6.2. Incompatibilities
None known.
6.3. Shelf Life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution Not applicable.
Shelf-life after first opening Not applicable.
6.4. Special Precautions for Storage
Store in a cool place; avoid freezing.
6.5. Nature and Content of Container
The product containers are aluminium tubes with screw caps contained in cartons:
a) Carton: White backed folding box board printed two colours on white.
b) Tube: Manufactured from 99.5% pure aluminium; lacquered internally, printed externally on white.
Pack sizes: 15g, 30g, 50g
6.6. Instructions for Use, Handling and Disposal
Not applicable.
MARKETING AUTHORISATION HOLDER
7
Actavis UK Limited (Trading style: Actavis) Whiddon Valley BARNSTAPLE N Devon EX32 8NS
8. MARKETING AUTHORISATION NUMBER
PL 0142/0131
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
12.7.79
Renewed: 12.7.84; 14.8.92; 19.8.97
10 DATE OF REVISION OF THE TEXT
30/04/2012