Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.
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.
None stated.
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.
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.
Alacort Cream is indicated in adults, children and infants.
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.
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.
None known.
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.
No special requirements.
