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Univate

Cream / Ointment


COMPOSITION
Univate Cream contains Clobetasol Propionate 0.05 % w/w in a non-greasy water miscible cream. Chlorocresol 0.15% w/w as preservative.
Univate Ointment contains Clobetasol Propionate 0.05% w/w in a fatty basis.

PROPERTIES
Clobetasol Propionate is a potent synthetic corticosteroid with anti-inflammatory, anti-pruritic and vasoconstrictive actions.

INDICATIONS
Univate is indicated for the treatment of severe inflammatory skin disorders such as eczema, discoid lupus erythematosus, psoriasis, lichen planus and other conditions or in patients which do not respond to less potent corticosteroids.

DOSAGE AND ADMINISTRATION
Apply sparingly onto the affected area 1 to 2 times a day. When a favourable response is obtained, reduce application gradually and eventually discontinue.

CONTRAINDICATIONS
Univate should not be used for acne, rosacea or on areas around the mouth; viral skin infections e.g. herpes simplex (cold sores) and chicken pox; fungal infections e.g. candidiasis; bacterial infections; in patients with a history of sensitivity to any of its components. The use of Univate is not indicated in the treatment of peri-anal and genital pruritus and dermatoses in children under one year of age, including dermatitis and napkin eruption.

PRECAUTIONS
If irritation develops with the use of Univate, treatment should be discontinued and appropriate therapy instituted.

Do Not Use UNIVATE:
a. For prolonged period
b. For extensive body surfaces
c. Together with occlusive dressings
d. In children and infants
e. In areas where the skin is thinner eg. eyes, face, in the ano-genital region
f. On broken or infected skin including cold sores, acne and athletes foot as systemic absorption may occur.


Avoid indiscriminate use in pruritus as a rebound exacerbation of the condition may occur when treatment is stopped.

 

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents.


DRUG INTERACTIONS
Topical application of Univate is not likely to produce significant drug interactions. Concurrent use of barbiturates, phenytoin, or rifampicin may enhance the metabolism and decrease the effect of corticosteroids.

USAGE DURING PREGNANCY
The safe use of topical corticosteroids in pregnancy has not been established, avoid excessive or prolonged use.

SIDE EFFECTS
Univate is generally well tolerated when used for short durations and over small areas. If application of more than 50g per week is used, clobetasol, being a potent corticosteroid, is likely to produce the severe side-effects associated with steroid use such as pituitary-adrenal-axis suppression. Local side-effects may include spread of local infections, thinning of the skin, irreversible striae atrophicae, increased hair growth, acne, mild depigmentation and growth of vellus hair and perioral dermatitis in young women, particularly when occlusive dressing are used or when skin folds are involved. Use of occlusive dressing increases the absorption of topical corticosteroids. In infants, the napkin may act as an occlusive dressing.

OVERDOSAGE AND TREATMENT
Overdosage of corticosteroids may cause adrenal atrophy and show signs of Cushing's syndrome, with moon face, striae, acne and buffalo hump. Treatment is symptomatic. Where possible, the drug should be slowly withdrawn.

SHELF-LIFE
3 years from the date of manufacture.

PRESENTATION
Univate Cream: White, odourless, water-miscible cream in packs of 450g and tubes of 15g.
Univate Ointment: White, smooth, homogenous fatty basis ointment in packs of 450g and tubes of 15g.


STORAGE
Store below 30C.
Keep out of reach of children

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