Clobetasol Propionate 0.05% Ointment
White ointment containing 0.05%
w/w of Clobetasol propionate in an ointment base.
Clobetasol propionate has anti-inflammatory, anti-pruritic, and
vasoconstrictive actions. When administered topically, particularly under
occlusive dressings 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.
Hypersensitivity to the
preparation, rosacea, acne vulgaris, peri-oral dermatitis, primary cutaneous
viral infections ( eg. herpes simplex, chicken pox ). The use of Cloderm
Ointment is not indicated in the treatment of primarily infected skin
lesions caused by infection with fungi ( eg. candidiasis, tinea ), or
bacteria ( eg. impetigo ), peri-anal and genital pruritus.
Reported local adverse reactions
are burning, itching, irritation, dryness, folliculitis, hypertrichosis,
acneiform eruptions, hypopigmentation, maceration of the skin, secondary
infection, skin atrophy, striae and miliria. 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.
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
outweights 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. Do not use in or around the eyes.
INSTRUCTIONS FOR THE PATIENT
Wash and dry affected area. Apply Cloderm Ointment sparingly to the affected
areas and rub in once or twice daily as directed by your doctor or
pharmacist. If symptoms persist please consult your doctor or pharmacist.
This preparation is for the treatment of your current condition only. Do not
allow sue by any other person and dispose of unused material when your
treatment is complete.
Plastic jars of 100g and 450g for export only
Collapsible aluminium tubes of 5g, 15g and 100g
Keep container well closed. Protect from strong light. Store below 30°C.
Keep out of the reach of children.