LOCOID LIPOCREAM

Contains 0.1% w/w hydrocortisone butyrate.

For excipients, see 6.1

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.

Due to the formulation of the base the product may be used both for dry scaly lesions and for moist or weeping lesions.

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 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

The active substance, hydrocortisone butyrate, is an established topical corticosteroid, equi-efficacious with those corticosteroids classified as potent.

In human in-vivo studies the potency of this formulation has been shown to be of the same order as other topical corticosteroids classified as potent. The active substance metabolises to hydrocortisone and butyric acid.

No relevant pre-clinical safety data have been generated

Macrogol cetostearyl ether

Cetostearyl alcohol

White soft paraffin

Light liquid paraffin

Sodium citrate anhydrous E331

Citric acid anhydrous E330

Propyl parahydroxybenzoate E216

Benzyl alcohol

Purified water

None stated.

Three years

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

Collapsible aluminium tube with plastic screw cap containing

15g, 30g, 50g or 100 g.

No special requirements.

Astellas Pharma Ltd.

3^rd Floor

Future House

The Glanty

Egham

Surrey

TW20 9AH

United Kingdom

PL 0166/0112

First authorised 3 May 1983; renewed 19 December 2003.

13^th December 2010

POM