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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 30°C.
Keep out of reach of children
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