HYDROCORTISONE OINTMENT BP 0.5% - summary of medicine 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 Contraindications

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.

Infected lesions,

Ulcerative conditions

Acne

4.4 Special warnings and precautions for use

The use of an occlusive dressing can considerably increase the degree of systemic absorption. If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially in children.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Remarks on indications

1. There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal 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 excluding widespread plaque psoriasis provided that warnings are given.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development tolerance, the 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. Prolonged application to the face is undesirable.

Caution should be taken to keep away from the eyes.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric

(clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard.

Washing clothing and bedding may reduce product build-up but not totally remove it.

Paediatric population

In infants and children particularly, care should be taken that the lowest strength of hydrocortisone cream that is clinically effective is used. Long-term continuous topical therapy should be avoided, where possible, as adrenal suppression can occur, even without occlusion.

Although generally regarded as safe, even for long-term administration in adults, there is potential for adverse effects if overused in infancy. 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 should therefore be limited, where possible, to a maximum of 7 days.

4.5 Interaction with other medicinal products and other forms of interaction

No interactions have been reported for topical hydrocortisone.

4.6 Fertility, pregnancy and lactation

Pregnancy

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.

Breast-feeding

There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area. There is theoretical risk of infant adrenal function impairment if maternal systemic absorption occurs.

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

Hydrocortisone preparations are usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately.

Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. 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. This effect is more likely to occur in infants and children, and if occlusive dressings are used or large areas of skin are treated.

Eye disorders:

Frequency Not known: Vision, blurred (see also section 4.4).

Skin and Subcutaneous Tissue Disorders:

Frequency Not known: Withdrawal reactions – redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4).

There are reports of pigmentation changes and hypertrichosis with topical steroids. Contact dermatitis may also occur.

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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Excessive use under occlusive dressings may produce adrenal suppression.

No special procedures or antidote.

Treat any adverse effects symptomatically. Acute overdosage is very unlikely to occur. 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

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. PHARMACEUTICAL PARTICULARS

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.

7 MARKETING AUTHORISATION HOLDER

Accord-UK Ltd

(Trading style: Accord)

Whiddon Valley

Barnstaple

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