Hydrocortisone Cream 1% P

Hydrocortisone cream is indicated for the treatment of irritant contact dermatitis, allergic contact dermatitis, mild to moderate eczema and insect bite reactions.

Posology

Adults and children: To be applied sparingly to the affected skin once or twice a day for a maximum of 7 days after gently cleansing the area.

Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age without medical advice.

Method of administration

For topical administration.

Apply accurately and sparingly to a small area. Massage gently into the skin.

Hypersensitivity to hydrocortisone acetate or to any other excipients listed in section 6.1

The product should not be used on the eyes or face (for example, in rosacea or perioral dermatoses), the ano-genital area or on broken or infected skin including impetigo, cold sores, acne athlete's foot, or infected bites and stings.

In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.

Not for use with an occlusive dressing or on large areas of the body.

The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6).

If the condition does not improve consult your doctor. Prolonged use of the product is not recommended (see section 4.2) as continuous uninterrupted application may cause local atrophy of the skin, striae and superficial vascular dilatation.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

The label will state mild steroid.

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.

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.

No known interactions.

Pregnancy

This product should not be used in pregnancy without medical advice. There are no or limited amount of data from the use of topical corticosteroids in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Breast-feeding

This product should not be used whilst breast-feeding unless recommended by a health care professional. Corticosteroids are excreted in human milk. There is no information about effects on lactation. A risk to new-borns/infants cannot be excluded.

Fertility

No known effects.

No adverse effects known.

If any signs of hypersensitivity, including allergic contact dermatitis or worsening of the original condition appear, treatment should be immediately discontinued.

Adverse events which have been associated with topical corticosteroids are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

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.

Acute overdose is highly unlikely. No special precautions or antidotes are likely to be needed. Chronic overdose or misuse may increase the risk of topical or systemic steroid-related adverse effects, including hypothalamic pituitary adrenal (HPA) axis suppression and Cushing's syndrome.

Management of overdose with topical corticosteroids includes gradual discontinuation under medical supervision.

Pharmacotherapeutic group: Corticosteroids, weak (group I), ATC code: D07AA02

Hydrocortisone is a corticosteroid which has anti-inflammatory activity.

Hydrocortisone acetate is a well characterised corticosteroid which has anti-inflammatory activity resulting, at least in part, from binding with a steroid receptor. Hydrocortisone acetate reduces inflammation by stabilising cell membranes, preventing the release of destructive enzymes, antagonising histamine and the release of kinins, inhibiting accumulation of macrophages and reducing capillary wall permeability and oedema formation.

Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layer and can be increased by inflammation or diseases of the epidermal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelids, face and scalp than from the forearm, knee, elbow, palm and sole.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

Whilst there is inadequate evidence on safety in human pregnancy, animal studies have demonstrated a possible association between topical corticosteroids and foetal abnormalities, including cleft palate and intra-uterine growth retardation.

Purified water, white soft paraffin, emulsifying wax, liquid paraffin, chlorocresol.

No major incompatibilities known.

36 months.

Store below 25°C.

An internally lacquered, collapsible aluminium tube with a wadless high-density polypropylene screw cap in a cardboard carton. Each tube contains 15g cream.

None.