HYDROCORTISONE 1.0% W/W CREAM (15GM PACK) - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Hydrocortisone 1.0% w/w Cream (15g Pack)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone 1.0% w/w

For excipients see 6.1.

3 PHARMACEUTICAL FORM

Soft white cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of irritant dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema.

4.2 Posology and method of administration

For topical application only.

Adults and children 10 years and over: use sparingly over a small area once or twice a day for a maximum period of 7 days.

4.3 Contraindications

Use on the eyes/face, ano-genital region, broken or infected skin including cold sores, acne and athlete’s foot.

Not recommended for use on children under 10 years of age without medical supervision.

4.4 Special warnings and precautions for use

Tell your doctor or pharmacist if you suffer from a chronic skin disease marked by itchy, scaly red patches known as psoriasis.

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 systemic toxicity due to impaired barrier function of the skin.

The application of hydrocortisone preparations under occlusive dressings on large areas of body should be avoided because of greater risk of toxicity resulting from increased systemic absorption.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

The label will carry the following warnings:

For external use only.

Do not use in pregnancy without medical advice.

Do not use on the eyes or face, anal or genital regions or on broken or infected skin including cold sores, acne and athlete’s foot.

If the condition does not improve after one week consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Fertility, pregnancy and lactation

Not recommended during pregnancy without first seeking medical advice.

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 intro-uterine growth retardation. There may therefore be a very small risk of such effects in human foetus.

It is not known if topical hydrocortisone is excreted in the breast milk. Problems in humans have not been documented, however risk-benefit must be considered when administering to nursing mothers.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Application of hydrocortisone cream to the skin has led to loss of skin collagen and subcutaneous atrophy and striae.

Slight stinging irritation, burning and itching has been reported. Allergic contact dermatitis, topical corticoid withdrawal syndrome and steroid acne has also been reported.

Skin and Subcutaneous Tissue Disorders

Not known (cannot be estimated from available data) Withdrawal reactions – redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4)

4.9 Overdose

Not applicable.

5.1 Pharmacodynamic properties

Hydrocortisone (cortisol) is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone cream when applied topically acts locally at the site of application. When applied to the skin, the site of action may be the epidermis, dermis or both.

Hydrocortisone cream diffuses across the cell membranes and forms a complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus and bind to DNA and stimulate transcription of messenger RNA and subsequent protein synthesis of various enzymes that are thought to be responsible for anti-inflammatory effects of topical application of adrenocorticoids. When absorbed systemically in sufficient quantities, its principal pharmacological actions are gluconeogenesis, glycogen deposition, protein and calcium metabolism, together with inhibition of corticotrophin secretion and anti-inflammatory activity.

5.2 Pharmacokinetic properties

Some hydrocortisone cream is absorbed systemically through the skin particularly in denuded areas.

The absorption of the topical dosage form is increased, when applied over an extensive area, after prolonged use or when an occlusive dressing is applied. It is also absorbed through the rectal mucosa and more so if the intestinal mucosa is inflamed. Hydrocortisone cream is metabolised mostly in the skin. Half-life of hydrocortisone cream is approximately 2 hours. Vehicles are very important in delivering the therapeutic agent at the site of action. Systemically absorbed hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as cortisone, tetrahydrocortisol, tetrahydrocor­tisone, cortol, cortolone, 11B-hydroxyetiocho­lanolone and 11-ketoetiochola­nolone. These are excreted in the urine mainly conjugated as glucuronides , together with a very small proportion of unchanged hydrocortisone. The plasma elimination half-life of hydrocortisone is about 60 minutes.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glyceryl Monostearate BP

Isopropyl Myristate BP

Polypropylene-15-Stearyl Ether

Synthetic Beeswax

Propylene Glycol BP

Aluminium Magnesium Silicate USNF

Polyoxyethylene- 10-Stearyl Ether

Polysorbate 80 BP

Citric Acid Monohydrate BP

Nipasept Sodium

Potassium Sorbate BP

Deionised Water

6.2 Incompatibilities

None.

6.3 Shelf life

24 months unopened.

6.4 Special precautions for storage

Store in a cool dry place.

Keep out of the sight and reach of children

6.5 Nature and contents of container

Lacquered aluminium tubes containing 15gm fitted, with 9mm, white polyethylene spiked flowerpot caps.

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Northumbria Pharma Ltd

Netpark

Thomas Wright Way

Sedgefield

County Durham

TS21 3FD

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 48259/0004