Hydrocortisone Skin Ointment 1%
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Skin Ointment 1%.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 10mg hydrocortisone BP (micro).
3 PHARMACEUTICAL FORM
Ointment, in an off-white, soft paraffin base.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Indications
Eczema and dermatitis of all types including atopic, infantile and discoid
eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis,
intertrigo, prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions.
Remarks on indications
1. There is no good evidence that topical corticosteroids are efficacious against immediate (type I) allergic skin reactions or short-lived wheal and flare reactions from other causes.
2. Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
3. Topical corticosteroids are not generally indicated in psoriasis but may be acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given, see Section 4.4 Special Warnings and Special Precautions for Use.
4.2. Posology and Method of Administration
Dosage: To be applied evenly and sparingly two or three times daily.
Adults and the Elderly: The same dose is used for adults and the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in the elderly.
Children: Long term treatment should be avoided where possible.
Infants: Therapy should be limited if possible to a maximum of seven days. Route:
Topical.
4.3. Contra-indications
Hypersensitivity to the preparation. Bacterial (eg impetigo) viral (eg herpes simplex) or fungal (eg candida or dermatophyte) infections, peri-oral dermatitis, acne vulgaris and rosacea.
4.4. Special Warnings and Special Precautions for Use
Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy including napkin eruption. In such patients, courses of treatment should not normally exceed 7 days.
In infants and children particularly, care should be taken that the lowest strength of hydrocortisone skin ointment that is clinically effective is used.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
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, application to the face may damage the skin and should be avoided.
Keep away from the eyes.
4.5. Interaction with Other Medicinal Products and Other Forms of Interaction
None known.
4.6. 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. Theoretically, there is the possibility that if maternal systemic absorption occurred the infant's adrenal function could be affected.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8. Undesirable Effects
Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Systemic absorption from such sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin treated.
4.9. Overdose
Excessive use under occlusive dressings may produce adrenal suppression.
No special procedures or antidote. Treat any adverse effects symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Corticosteroids used in topical presentations for anti-infammatory activity are of value in the treatment of a wide variety of dermatological conditions. The anti-inflammatory actions are mediated by reducing prostaglandin synthesis in several skin cell types. This interrupts the release of mediators such as leukotrienes, which play a part in the development of eczema and dermatitis.
5.2. Pharmacokinetic Properties
Any hydrocortisone that is absorbed through the skin is metabolised mainly by the liver 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 portion of unchanged hydrocortisone.
5.3. Preclinical Safety Data
Not required.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Wool fat, liquid paraffin, white soft paraffin.
6.2. Incompatibilities
None.
6.3. Shelf Life
24 months.
6.4. Special Precautions for Storage
Store below 25oC.
6.5. Nature and Contents of Container
Container: A collapsible aluminium tube, with internal epoxylacquer and a white plastic cap.
Pack sizes: 5gm, 10gm, 15gm, 20gm and 30gm.
6.6. Instructions for Use/Handling
For external use only.
7 MARKETING AUTHORISATION HOLDER
Sandoz Limited 37 Woolmer Way Bordon Hampshire GU 35 9QE United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 04416/0255
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/07/2000
10 DATE OF REVISION OF THE TEXT
20/04/2011