Cream: A white cream containing Clobetasol propionate 0.0568% w/w (equivalent to Clobetasol 0.05%) with 0.1% Chlorocresol as perservative.
Ointment: White ointment containing 0.0568% w/w of Clobetasol propionate (equivalent to Clobetasol 0.05%) in an ointment base.
Pharmacology: Clobetasol propionate has anti-inflammatory, anti-pruritic, and vasoconstrictive actions. When administered topically, particularly under occlusive dressing or when the skin is broken, sufficient corticosteroid may be absorbed to give systemic effects. Corticosteroids are extensively bound to plasma proteins. Only unbound corticosteroids have pharmacological effects or are metabolized. They are metabolized mainly in the liver, also in the kidneys, and are excreted in the urine.
For short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid - responsive dermatoses.
Wash and dry affected area. Apply Cloderm sparingly to the affected areas and rub in once or twice daily as directed by the doctor or pharmacist. If symptoms persist, please consult the doctor or pharmacist. This preparation is for the treatment of the current condition only. Do not allow use by any other person and dispose of unused material when the treatment is complete.
Hypersensitivity to the preparation, rosacea, acne vulgaris, peri-oral dermatitis, primary cutaneous viral infections (e.g. herpes simplex, chicken pox). The use of Cloderm is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi (e.g. candidiasis, tinea), or bacteria (e.g. impetigo), peri-anal and genital pruritus. Not recommended for infants under 1 year of age.
Discontinue use if irritation or sensitivity develops. Safety of its use during pregnancy and lactation has not been established. Thus, it should be used only if the potential benefit outweighs the potential risk to the foetus or nursing infant. Special care must be taken when giving to paediatric patients as systemic absorption can occur in topical administration causing growth retardation. Caution is advised if the medication is to be applied to extensive surface area. Long-term continuous topical therapy should be avoided. Not suitable for ophthalmic use.
Safety of its use during pregnancy and lactation has not been established.
Reported local adverse reactions are burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Large doses of corticosteroids may produce symptoms typical of hyperactivity of the adrenal cortex, with moon face, sometimes with hirsutism, buffalo hump, flushing, sometimes leading to a fully developed Cushing's syndrome.
Keep container well closed. Protect from strong light. Store below 30°C.
Shelf-life: 3 years.
D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.
Cream/oint 0.05% w/w x 15 g, 450 g.