Cloderm

Cloderm

clobetasol

Manufacturer:

Hoe Pharma

Distributor:

Zuellig Pharma

Marketer:

Taisho Pharmaceutical
Full Prescribing Info
Contents
Clobetasol propionate.
Description
Ointment: Each gram of ointment contains 0.0568% w/w of Clobetasol propionate (equivalent to clobetasol 0.05%) in an ointment base.
Action
Pharmacology: Pharmacodynamics: Clobetasol Propionate has anti-inflammatory, anti-pruritic, and vasoconstrictive actions.
Pharmacokinetics: 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 has pharmacological effects or is metabolized. They are metabolized mainly in the liver, also in the kidneys, and are excreted in the urine.
Indications/Uses
Ointment: For short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses.
Scalp Application: Psoriasis and recalcitrant eczemas of the scalp. Clobetasol is a highly-active topical corticosteroid which is indicated for use in short courses for conditions which do not respond satisfactorily to less active steroids.
Dosage/Direction for Use
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.
Overdosage
Corticosteroid applied to the skin can be absorbed in sufficient amount to produce systemic effect such as hypothalamic-pituitary-adrenal axis suppression, manifestation of Cushing's syndrome, hyperglycaemia and glucosuria. Tests which may be helpful in evaluating hypothalamic-pituitary-adrenal axis suppression include urinary free cortisol test and ACTH stimulation test. If the hypothalamic-pituitary-adrenal axis suppression is found, then the drug should be withdrawn, frequency of application reduced or a weaker steroid used. Supplemental systemic corticosteroids may be required if signs and symptoms of steroid withdrawal occur.
Contraindications
Ointment: Hypersensitivity to the preparation, rosacea, acne vulgaris, peri-oral dermatitis, primarily cutaneous viral infections (eg. herpes simplex, chicken pox). The use of Cloderm Ointment is not indicated in the treatment of primary infected skin lesions caused by infection with fungi (eg. candidiasis, tinea), or bacteria (eg. impetigo), peri-anal and genital pruritus. Not recommended for infants under 1 year of age.
Scalp Application: Hypersensitivity to the preparation, infections of the scalp, dermatoses in children under one year of age including dermatitis.
Special Precautions
Discontinue use if irritation or sensitivity develops. 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.
Use in children: Special care must be taken when giving to paediatric patients as systemic absorption can occur in topical administration causing growth retardation.
Use In Pregnancy & Lactation
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.
Adverse Reactions
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 Interactions
Unknown.
Caution For Usage
If symptoms persist please consult a doctor or pharmacist. This preparation is for the treatment of current condition only. Do not allow use by any other person and dispose of unused material when the treatment is complete.
Storage
Keep container well closed. Protect from strong light. Store below 30°C.
Recommended shelf-life: 3 years.
ATC Classification
D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.
Presentation/Packing
Cream 0.05% x 15 g. Oint (white) 0.05% x 15 g. Scalp application (colourless, slightly viscous solution) 0.05% x 30 mL.
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