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Cloderm ointmentCloderm ointment

Clobetasol Propionate 0.05% Ointment

 

DESCRIPTION

White ointment containing 0.05% w/w of Clobetasol propionate in an ointment base.

PHARMACOLOGY
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.

INDICATIONS

For short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid responsive dermatoses.

CONTRAINDICATIONS

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.

 

ADVERSE EFFECTS

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.

 

DRUG INTERACTION

Unknown

 

PRECAUTIONS

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.

PACKING

Plastic jars of 100g and 450g for export only

Collapsible aluminium tubes of 5g, 15g and 100g

STORAGE

Keep container well closed. Protect from strong light. Store below 30C. Keep out of the reach of children.

SHELF-LIFE

3 years

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