Dermacort Hydrocortisone Cream

1. Name of the medicinal product

Dermacort Hydrocortisone Cream

 

2. Qualitative and quantitative composition

Dermacort Hydrocortisone Cream contains hydrocortisone B.P. 0.1% w/w in a specially formulated, lanolin-free cream base.

 

3. Pharmaceutical form

Cream.

 

4. Clinical particulars

4.1 Therapeutic indications

Topical treatment of skin irritations, contact dermatitis, allergic contact dermatitis and rashes due to reactions to plants, insect bite, jewellery, toiletries, deodorants, soaps and detergents. Dermacort is also indicated for the treatment of mild to moderate eczema.

 

4.2 Posology and method of administration

For cutaneous use.

Adults and children over 10 years:

Apply a thin layer to cover the affected area once or twice a day.

Rub in gently until the cream disappears.

Do not use for more than one week.

 

4.3 Contraindications

For external use only.

Known sensitivity to hydrocortisone and/or other excipients in this product.

Do not use on the eyes or face, the ano-genital region, on broken or infected skin.

As with all topical steroids, Dermacort is contra-indicated in the presence of viral, bacterial and fungal diseases of the skin.

 

4.4 Special warnings and precautions for use

See above

 

4.5 Interaction with other medicinal products and other forms of interaction

None known

 

4.6 Pregnancy and lactation

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 intrauterine growth retardation.

Dermacort should not be used during pregnancy.

 

4.7 Effects on ability to drive and use machines

Not applicable.

 

4.8 Undesirable effects

Dermacort is normally well tolerated, but if signs of hypersensitivity appear application should stop immediately.

 

4.9 Overdose

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation topical steroids should be discontinued.

 

5. Pharmacological properties

5.1 Pharmacodynamic properties

Corticosteroids are used in pharmacological doses for their anti-inflammatory and immunosuppressive glucocorticoid properties which suppress the clinical manifestation of a wide range of disease. Although many synthetic derivatives have been developed, hydrocortisone is still used widely in topical formulations for mild and transient inflammatory dermatitis. It has the advantage over its synthetic derivatives that it is metabolised in the skin and therefore cannot accumulate to form a depot, which may result in local side effects.

 

5.2 Pharmacokinetic properties

The cream formulation of Dermacort was developed in order to optimise the release and partition of its active ingredient, hydrocortisone, into the skin. The hydrocortisone is presented as a saturated or near saturated solution in aqueous propylene glycol, which represents the continuous phase of the emulsion system. It has been shown, by the vasoconstrictor assay on normal skin, that in this environment, a 0.1% concentration of the hydrocortisone is equivalent to the 1% concentration where the drug substance is in suspension. Clinical studies have confirmed that 0.1% Dermacort is equivalent to 1.0% hydrocortisone cream BP/BPC whilst the reduced strength of Dermacort increases the margin of safety.

 

5.3 Preclinical safety data

None applicable.

 

6. Pharmaceutical particulars

6.1 List of excipients

Propylene Glycol

Emulsifying Ointment

Citric Acid

Purified Water

 

6.2 Incompatibilities

None stated.

 

6.3 Shelf life

24 months.

 

6.4 Special precautions for storage

None.

 

6.5 Nature and contents of container

Lacquered Aluminium Tubes containing 15 g of cream

 

6.6 Special precautions for disposal and other handling

None.

 

7. Marketing authorisation holder

Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wilts SN8 1LW

 

8. Marketing authorisation number

PL 23138/0007

 

9. Date of first authorisation/renewal of the authorisation

01/03/2007

 

10. Date of revision of the text