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.

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.

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.

Infants

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.

Keep away from the eyes.

No interaction studies have been performed.

Pregnancy

There are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women. Studies in animals have shown reproductive toxicity.

Breast-feeding

Hydrocortisone butyrate/metabolites are excreted in human milk, but at therapeutic doses of Locoid Cream no effects on the breast-fed newborns/infants are anticipated.

None known.

Tabulated list of adverse reactions

System Organ Class	Rare >/10,000,<1/1000	Very rare </10,000	Not known
Immune system disorders			Hypersensitivity
Endocrine disorders		Adrenal suppression
Skin and subcutaneous tissue disorders	Skin atrophy, often irreversible, with thinning of the epidermis Telangiectasia Skin striae Pustular acne Perioral dermatitis Rebound effect Skin depigmentation Dermatitis and eczema, including contact dermatitis

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.

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

Pharmacotherapeutic group: Corticosteroid, ATC code: D07AB02.

Hydrocortisone butyrate is a potent topical corticosteroid.

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

Corticosteroid, ATC code: D07AB02.

Preclinical safety data

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.

List of excipients

Cetostearyl alcohol

Macrogol Cetostearyl ether

Light Liquid Paraffin

White Soft Paraffin

Butyl parahydroxybenzoate

Propyl parahydroxybenzoate

Citric Acid (anhydrous)

Sodium Citrate (anhydrous)

Purified Water.

Incompatibilities