LOCOID CREAM

Contains 0.1% w/w hydrocortisone butyrate.

For excipients, see 6.1

Cream

White to practically white cream.

The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids e.g. eczema, dermatitis and psoriasis.

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.

For topical application.

Dosage: To be applied evenly and sparingly no more than twice daily.

Application may be made under occlusion in the more resistant lesions such as thickened psoriatic plaques on elbows and knees.

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.

Hypersensitivity to hydrocortisone or to any of the ingredients of the cream.

This preparation is contraindicated in the presence of untreated viral or fungal infections, tubercular or syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.

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.

Application under occlusion should be restricted to dermatoses involving limited areas.

As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.

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. Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important.

Keep away from the eyes

The cetostearyl alcohol may cause local skin reactions (e.g contact dermatitis) and the butyl and propyl parahydroxybenzoate may cause allergic reactions which can be delayed.

None known.

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.

The use of topical corticosteroids during lactation is unlikely to present a hazard to infants being breast-fed.

None known.

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.

Hydrocortisone butyrate is a potent topical corticosteroid.

The topical activity has been demonstrated in vivo using the McKenzie-Stoughton test.

No preclinical safety data have been generated.

Cetostearyl alcohol, Macrogol Cetostearyl ether, Light Liquid Paraffin, White Soft Paraffin, Butyl parahydroxybenzoate, Propyl parahydroxybenzoate, Citric Acid (anhydrous), Sodium Citrate (anhydrous), Purified Water.

None stated.

3 years

Do not store above 25°C. Do not refrigerate or freeze.

Collapsible aluminium tubes containing either 30 G, 50 G, 100 G or 200G. Packed in a carton.

No special requirements.

Astellas Pharma Ltd.

3^rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

PL 00166/0058R

First authorised 28 September 1973, renewed 19 December 2003.

13^th December 2010

POM