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HYDROCORTISONE SKIN OINTMENT 1%

Active substance(s): HYDROCORTISONE MICRO

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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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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