Summary of Product Characteristics (SmPC) - Hydrocortisone 1.0% w/w cream (15GM Pack)
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
Posology
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.
Method of administration
For topical application only.
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
The label will state mild/moderate/strong/very strong steroid.
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.
Topical Steroid Withdrawal Syndrome
Long term 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
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)
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 Yellow Card Scheme Website: 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
ATC code: D07A A02
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
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23rd February 2001
10 DATE OF REVISION OF THE TEXT
11/06/2024