MIMS Revision Date: 01 November 2019

1 Name of Medicine

Hydrocortisone.

2 Qualitative and Quantitative Composition

DermAid Soft 1% cream. Hydrocortisone 1% (10 mg/g).
DermAid Soft 0.5% cream. Hydrocortisone 0.5% (5 mg/g).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DermAid Soft Cream is a soft cream for topical application.

4 Clinical Particulars

4.1 Therapeutic Indications

DermAid Soft Cream is indicated for topical application for the temporary relief of symptoms associated with acute and chronic corticosteroid responsive conditions, including minor skin irritations, itching and rashes due to eczema, dermatitis, contact dermatitis (such as rashes due to soap, detergent, cosmetics and jewellery), psoriasis, non-infected anogenital pruritus, and sunburn.

4.2 Dose and Method of Administration

A thin layer should be applied to the affected skin two to four times a day. Once the inflammation has subsided the frequency of may be reduced.

4.3 Contraindications

Acne.
Hypersensitivity to any of the ingredients.
Do not use in the eye.
Like all other topical corticosteroids, DermAid Soft Cream is contraindicated in skin infections and infestations such as chickenpox, herpes and other viral infections.
Hydrocortisone may mask signs of infection. If any infection is present, an appropriate anti-infective agent should be used first. DermAid Soft Cream may be used to reduce inflammation but if a favourable response does not occur promptly then use of the product should be discontinued until the infection has been adequately controlled.
If any skin irritation develops, discontinue use and treat appropriately. If extensive areas are treated, or if occlusive dressings are used, the possibility also exists for increased systemic absorption and this could in turn lead to the depression of the hypothalamo-pituitary-adrenal axis. In all such patients it is essential to monitor adrenal function at regular intervals.

4.4 Special Warnings and Precautions for Use

Long-term continuous topical therapy should be avoided where possible, particularly in children, as adrenal suppression can occur (even without occlusion).
As with other topical corticosteroids, when extensive areas are treated, sufficient systemic absorption may occur to produce the features of hypercorticalism. This effect is more likely to result if occlusive dressings are used or if treatment is prolonged. Rarely, local atrophy or striae may occur after prolonged treatment. This must be borne in mind when treating conditions such as severe eczema and seborrhoeic dermatitis. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as glaucoma may result. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions that have become infected.
Topical corticosteroids should be used with caution in patients with primary skin infections. Any spread of the infection requires withdrawal of corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions associated with occlusive dressings, so the skin should be cleansed prior to a fresh dressing being applied.
Patients in whom there is a risk of increased systemic absorption should be regularly evaluated for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression by using urinary free cortisol (hydrocortisone) tests and monitoring morning plasma cortisol levels.
If there is evidence of suppression, attempts should be made to withdraw the drug or reduce the frequency of application. If hypersensitivity occurs, stop application and institute appropriate therapy. If irritation occurs, discontinue use. Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if occlusion is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated.
Withdrawal of corticosteroid therapy may exacerbate psoriasis. The frequency of application should be reduced before withdrawing the therapy. Therapy may be continued with a milder preparation such as Egoderm cream or ointment.
Use in the elderly. No data available.
Paediatric use. The risk of systemic absorption, and hence systemic toxicity, is greater in children due to a larger skin surface to body weight ratio than adults. The preparation is not recommended for use in children under 2 years of age except on the advice of a doctor.
Effects on laboratory tests. No data available.
Visual disturbance. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interactions known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category A)
Category A: Drugs which have been taken by a large number of pregnant women and women of child bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Use in lactation. It is not known whether sufficient absorption of topical corticosteroids takes place to be excreted in breast milk. The potential benefits should be weighed against possible hazards to the breastfeeding infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

After the application of DermAid Soft Cream a slight stinging sensation may occasionally be noticed. This transient symptom is most likely to disappear after several applications.
Intolerance to the occlusive dressing (miliary eruptions, folliculitis) may be expected to be observed, as with other corticosteroids. In such cases the use of an occlusive dressing should be discontinued. Use of the steroid may also need to be reduced or discontinued as local atrophy and striae of the skin may be observed.
In long-term treatment of extensive skin areas with occlusive dressings, one should bear in mind the possibility of inhibition of adrenal function. Therefore, adrenal function should be monitored under these circumstances.
Systemic adverse reactions, such as blurred vision, have also been reported with the use of topical corticosteroids.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Percutaneous absorption of corticosteroids may occur, especially under occlusive conditions. The following adverse effects have been reported with topical steroids: burning; itching; irritation; skin atrophy; secondary infection; dryness; acnederm eruptions and hypopigmentation. Treatment should be chiefly symptomatic and administration of the steroid should be discontinued.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Hydrocortisone is believed to be the principal glucocorticoid secreted by the adrenal cortex. It is used as replacement therapy in adrenocortical deficiency states. It is also used for its potent anti-inflammatory effects in disorders of many organ systems.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Absorption. DermAid Soft Cream contains hydrocortisone. Hydrocortisone has anti-inflammatory, anti-eczematous, anti-allergic and anti-pruritic properties. Hydrocortisone is absorbed through the skin allowing penetration to the deeper layers. The extent of absorption is greater for inflamed skin and other skin conditions such as eczema and psoriasis. Absorption is also greater in areas such as the ear, scrotum, axillae, face and scalp. Absorption is aided by occlusive dressings due to the resulting hydration of the skin. Once absorbed, the pharmacokinetics are similar to systemic steroids.
Metabolism. Hydrocortisone is metabolised in the liver most likely by reduction of the 5,6 double bond and the C3 and C20 keto groups. The resultant hydroxy derivatives are then conjugated with glucuronic acid. Cortisone, an 11-keto-steroid, is formed from hydrocortisone; the 11-keto-steroid is formed from hydrocortisone; the 11-keto-steroids are then reduced and conjugated to yield glucuronide metabolites. A small percentage of hydrocortisone is converted to the 17-keto-steroid. The C21 hydroxyl group is conjugated with sulphate.
Excretion. When radioactive-carbon, ring-labelled steroids are injected intravenously in man, most of the radioisotope is recovered in the urine within 72 hours. Neither biliary nor faecal excretion is of any quantitative importance in man. It has been estimated that the liver metabolises at least 70% of the hydrocortisone secreted.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each gram of DermAid Soft Cream contains hydrocortisone (10 mg/g or 5 mg/g, as appropriate) in a soft cream base of 1,3-butylene glycol, cetostearyl alcohol, citric acid, dimeticone 350, disodium edetate, self-emulsifying glyceryl monostearate, light liquid paraffin, PEG-40 stearate, povidone, dibasic sodium phosphate, purified water, xanthan gum and phenethyl alcohol (as preservative).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

DermAid 0.5% cream. Store below 25°C.
DermAid 1% cream. Store below 25°C.

6.5 Nature and Contents of Container

DermAid Soft 0.5% cream. 15 g*, 30 g laminate tube with a tamper evident seal packed into a carton.
DermAid Soft 1% cream. 15 g*, 30 g laminate tube with a tamper evident seal packed into a carton.
* Not currently marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number. 50-23-7.

7 Medicine Schedule (Poisons Standard)

S2 (0.5%); S3 (1%).

Date of First Approval

01 August 1999

Date of Revision

05 April 2019

Summary Table of Changes