Components:
Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 2020-04-09
Attention! Information on this page is intended only for medical professionals! Information is collected in open sources and may contain significant errors! Be careful and double-check all the information on this page!
Locoid cream
Locoid Cream contains 0.1% w/w hydrocortisone butyrate.
Excipient(s) with known effect:
<Cream.
The product is a white to practically white cream.
Locoid Cream is indicated in adults, children and infants.
Posology
Adults and older people
The same dose is used for adults and older people, as clinical evidence would indicate that no special dosage regimen is necessary in older people.
Paediatric population
Long term treatment should be avoided where possible.
Infants
Therapy should be limited if possible to a maximum of seven days.
Method of administration
For cutaneous use.
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.
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.
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.
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 200 g packed in a carton.
Not all pack sizes may be marketed.
No special requirements.
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
PL 05293/0010
Date of first authorisation: 28 September 1973
Date of latest renewal: 24 August 2010.
06 September 2016
However, we will provide data for each active ingredient
