Canesten HC Cream

Clotrimazole 1% w/w and hydrocortisone 1% w/w

For excipients, see 6.1.

Cream.

Canesten HC is indicated for the treatment of the following skin infections where co-existing symptoms of inflammation, e.g. itching, require rapid relief:

a) All dermatomycoses due to dermatophytes (e.g. Trichophyton species), moulds and other fungi.

b) All dermatomycoses due to yeasts (Candida species).

c) Skin diseases showing secondary infection with these fungi.

d) The treatment of nappy rash where infection due to Candida albicans is present. Candidal vulvitis, candidal balanitis and candidal intertrigo.

Clotrimazole is a broad spectrum antifungal. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides. It has no effect on lactobacilli.

Canesten HC Cream should be thinly and evenly applied to the affected area twice daily and rubbed in gently. Treatment should be for a maximum of 7 days.

There is no separate dosage schedule for the elderly or the young. However, long-term therapy to extensive areas of skin should be avoided particularly in infants and children.

Hypersensitivity to Clotrimazole, hydrocortisone or any of the excipients in this product.

Hypersensitivity to cetostearyl alcohol

The following contra-indications apply to the hydrocortisone component: any untreated bacterial skin diseases, chicken pox, vaccination reactions, perioral dermatitis, viral skin diseases (e.g. herpes simplex, rosacea, shingles), use on broken skin, acne.

Because of its corticosteroid content, Canesten HC should not be applied:

• to large areas (more than 5 - 10% of the body surface).

• in long term continuous therapy.

• under occlusive dressings.

These restrictions apply particularly in:

• Infants, where the nappy can act as an occlusive dressing and increase systemic absorption.

• Infants and children, where increased systemic absorption may occur resulting in adrenocortical suppression

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced. To date this has not been reflected in clinical practice.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this to humans has not been established. In animal studies, clotrimazole has not been associated with teratogenic effects but, following oral administration of high doses to rats, there was evidence of foetotoxicity. The relevance of this effect to topical administration in humans is not known.

However, clotrimazole has been used in pregnant patients for over a decade without attributable adverse effects.

It is therefore recommended that Canesten HC Cream should be used in pregnancy and lactation only when considered essential by the clinician.

None applicable.

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible

Immune system disorder: allergic reaction (syncope, hypotension, dyspnea, urticaria)

Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning

After use on large areas (more than 10% of the body surface) and/or after long-term use (longer than 2-4 weeks) or use under occlusive dressings, local skin alterations such as skin atrophy, teleangiectasias, hypertrichosis, striations, hypopigmentation, secondary infection and acneiform symptoms may occur.

In the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting).

ATC Code: D01A C20

Canesten HC is a combination of clotrimazole, which is an imidazole derivative, and hydrocortisone, which is a glucocorticoid. Canesten HC is a broad spectrum antimycotic.

Mechanism of Action

Clotrimazole

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

Hydrocortisone

Hydrocortisone is a weak corticosteroid with both glucocorticoid and to a lesser extent mineralocorticoid activity. As the active ingredient in a topical cream it exerts anti-inflammatory, antipruritic, antiexudative and antiallergic effects.

Pharmacodynamic Effects

Canesten HC has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.

Primary resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

Hydrocortisone exerts an anti-inflammatory, immunosuppressive, antimitotic (antiproliferative), antipruriginous and vasoconstrictive effect on the skin. Thus, in addition to the elimination of inflammation and pruritis, a normalisation of keratinisation, inhibition of excess fibroblast activity and epidermopoiesis, degradation of pathological metabolic products and inhibition of acantholysis are achieved.

Clotrimazole:

Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.01 mcg/ml, suggesting that clotrimazole applied topically in unlikely to lead to measurable systemic effects or side effects.

Hydrocortisone:

Dermal absorption of hydrocortisone depends on the thickness and condition of the skin. In healthy skin no systemic effects of corticoids have been observed after local application.

However, in the case of inflamed or damaged skin, cutaneous absorption may be increased depending on the site of application, use of occlusive dressings, the degree of skin damage, and size of the treated area. Systemic effects can not be ruled out under such conditions.

An increase in the skin temperature or moisture content, e.g. in skin folds or under an occlusive dressing, also promotes absorption. In infants and small children the epidermal "barrier" is still poorly developed, which facilitates transcutaneous uptake of drugs. The occurrence of systemic effects depends partly on the dose and, to a much greater extent, on the duration of treatment.

More than 90% of the hydrocortisone absorbed is bound to plasma proteins. Hydrocortisone is metabolised in the liver and tissues, and the metabolites are excreted with urine. The biological half-life is approximately 100 minutes.

No relevant absorption of hydrocortisone is expected after its use for a short period on limited skin inflamed areas.

There are no preclinical safety data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

Benzyl alcohol

Cetostearyl alcohol

Medium chain triglycerides

Triceteareth-4 phosphate

Purified water

Not applicable

30 months.

Do not store above 25°C.

Aluminium tube with internal lacquer coating and HDPE screw-on cap in cardboard carton.

Pack sizes available: 30g, 15g and 5g sample pack.

No special requirements

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

Trading as Bayer plc, Consumer Care Division

PL 0010/0120

2 July 2010