HYDROCORTISONE Cream Ref.[7550] Active ingredients: Hydrocortisone

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.

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.

This product contains cetostearyl alcohol and chlorocresol amongst the excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Chlorocresol may cause allergic reactions. Treatment with hydrocortisone cream should be discontinued if either of these reactions develops.

No interactions have been reported for topical hydrocortisone.

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.

Hydrocortisone does not affect the ability to drive and use machines.

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).

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

None known.