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Canesten Hydrocortisone Cream 15g
Clotrimazole 1% w/w and hydrocortisone 1% w/w.
Canesten Hydrocortisone is indicated for the treatment of the following skin infections where co-existing symptoms of inflammation, eg. itching, require rapid relief:
(i) Athlete's foot.
(ii) Candidal intertrigo.
Clotrimazole is a broad spectrum antifungal. It also exhibits activity against Trichomonas, staphylococci, streptococci and Bacteroides. It has no effect on lactobacilli.
Adults, elderly and children age 10 years and over:
Canesten Hydrocortisone should be thinly and evenly applied to the affected area twice daily and rubbed in gently. The maximum period of treatment is seven days.
Contraindications
Canesten Hydrocortisone is contra-indicated in the following cases:
- Use on broken skin.
- Use on large areas of skin.
- Use for periods of longer than seven days.
- Hypersensitivity to hydrocortisone, clotrimazole, cetostearyl alcohol or any of the ingredients of this product.
- To treat cold sores or acne.
- Use on the face, eyes, mouth or mucous membranes.
- Children under 10 years of age, unless prescribed by a doctor.
- Pregnancy and lactation, unless prescribed by a doctor.
- Use on the ano-genital area, unless prescribed by a doctor.
- To treat ringworm, unless prescribed by a doctor.
- To treat secondarily infected skin conditions, unless prescribed by a doctor.
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).
Special warnings and precautions for use.
Because of its corticosteroid content, Canesten Hydrocortisone should not be applied:
• To large areas (more than 5 - 10% of the body surface).
• In long term continuous therapy.
• Under occlusive dressing
These restrictions apply particularly in children, where increased systemic absorption may occur resulting in adrenocortical suppression.
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis)
Pregnancy and lactation
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 application 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 Hydrocortisone should be used in pregnancy and lactation only when considered necessary by the clinician.
Undesirable effects
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). It should be carried out only if the airway can be protected adequately.
List of excipients
Triceteareth - 4 phosphate
Cetostearyl alcohol
Medium chain triglycerides
Benzyl alcohol
Purified water
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