HYDROCORTISONE 1.0% W/W OINTMENT - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Hydrocortisone 1.0% w/w Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone 1.0% w/w.

Excipients with known effect

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Ointment.

Tube containing a faintly off-white translucent ointment.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Eczema and dermatitis of all types including atopic eczema, photo dermatitis, otitis extema, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions.

4.2 Posology and method of administration

Use sparingly over a small area once or twice a day for a maximum period of one week or as directed by a physician.

For topical application only.

4.3 Contraindications

Bacterial (e.g. Impetigo), Viral (e.g. Herpes simplex) or Fungal (e.g. Candida or Dermatophyte) infections.

4.4 Special warnings and precautions for use

The application of hydrocortisone preparations under occlusive dressing on large areas of body should be avoided because of greater risk of toxicity resulting from increased systemic absorption. Adrenal suppression and growth retardation due to systemic absorption of topical hydrocortisone has been reported in children. It is, therefore, advisable that special care must be exercised when using hydrocortisone in paediatric patients, especially when extensive (more than 5–10 percent) areas are being treated or the preparation is used under an occlusive dressing.

Long term use in patients with diabetes and tuberculosis should also be avoided. After prolonged use, patients should be observed for signs of hydrocortisone toxicity such as acne or oily skin, filling or roundness of the face, reddish purple lines on arms, face, legs, trunk or groin, thinning of skin with easy bruising, unusual increase in hair growth especially on the face and unusual loss of hair especially on the scalp. Although generally regarded as safe, even for long-term administration in adults, there is a potential for over dosage 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.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalized pustular psoriasis and local systemic toxicity due to impaired barrier function of the skin.

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.

Topical steroid withdrawal syndrome

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.

4.5 Interaction with other medicinal products and other forms of interaction None.

4.6 Fertility, pregnancy and lactation

Pregnancy

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.

Breast-feeding

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 ointment 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 and steroid acne has also been reported.

Eye Disorders

Frequency uncommon (may affect up to 1 in 100 people)

Vision blurred (see also section 4.4).

Skin and Subcutaneous Tissue Disorders

Frequency 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)

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, weak (group 1); ATC code: D07AA02

Hydrocortisone (cortisol) is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone ointment 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 ointment 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

Absorption

Some hydrocortisone ointment 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.

Distribution

Hydrocortisone ointment is metabolised mostly in the skin. Half-life of hydrocortisone ointment is approximately 2 hours. Vehicles are very important in delivering the therapeutic agent at the site of action.

Biotransformation

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.

Elimination

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

Not applicable.

6.1

White Soft Paraffin

Liquid Paraffin

Wool Fat

6.2

None.

6.3

36 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 fitted with plastic screw caps.

Pack sizes 25, 30, 40, and 50 g.

6.6 Special precautions for disposal

7   MARKETING AUTHORISATION HOLDER

8 MARKETING AUTHORISATION NUMBER(S)

PL 16431/0029

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

Date of first authorisation: 23 February 2001

Date of latest renewal: 31 August 2006