Clobetasol 0.05% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clobetasol propionate

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

D07AD01

INN (International Name):

Clobetasol propionate

Dosage:

500microgram/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

DERMOVATE
® CREAM
CLOBETASOL 0.05%W/W CREAM
(clobetasol propionate)
Your medicine is known by one of the above names, but will be referred
to
as Dermovate throughout this:
PATIENT INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET:
1) What Dermovate is and what it is used for
2) What you need to know before you use Dermovate
3) How to use Dermovate
4) Possible side effects
5) How to store Dermovate
6) Contents of the pack and other information
1) WHAT DERMOVATE IS AND WHAT IT IS USED FOR
Dermovate contains a medicine called clobetasol propionate. It belongs
to
a group of medicines called steroids. It helps to reduce swelling and
irritation.
Dermovate is used to help reduce the redness and itchiness of certain
skin
problems. These skin problems include:
•
frequently relapsing eczema
•
psoriasis (thickened patches of inflamed, red skin, often covered by
silvery scales), excluding widespread plaque psoriasis
•
lichen planus, (a skin disease that causes itchy, reddish-purple,
flat-
topped bumps on the wrists, forearms or lower legs)
•
discoid
lupus
erythematosus
(a
disease
of
the
skin
most
often
affecting the face, ears and scalp causing scarring and increased
sensitivity of the affected skin to sunlight)
•
dermatitis and other skin conditions that have not responded to milder
steroid creams or ointments.
2) WHAT YOU NEED TO KNOW BEFORE YOU USE DERMOVATE
DO NOT USE DERMOVATE:
•
if you are allergic (hypersensitive) to clobetasol propionate or any
of
the other ingredients of this medicine (listed in Section 6)
•
on a child under 1 year of age
•
to treat any of the following skin problems, it could make them worse:
−
acne
−
severe flushing of skin on and around your nose (rosacea)
−
spotty red rash around your mouth (perioral dermatitis)
−
itching around your anus or genitals (penis or vagina)
−
infected skin (unless the infection is being treated with an anti-
infective medicine at the same time)
−
itchy skin which is not inflamed
−
widespread plaque psoriasis, except single lesions.
Do not use

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clobetasol Propionate 0.05% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains 0.5 mg of clobetasol propionate (0.05% w/w).
Also contains 80 mg of cetostearyl alcohol, 475 mg of propylene glycol
and
0.75 mg of chlorocresol in each gram of the cream.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White or almost white cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobetasol propionate is a very active topical corticosteroid which is
of
particular value when used in short courses for the treatment of more
resistant
dermatoses such as psoriasis (excluding widespread plaque psoriasis),
recalcitrant eczemas, lichen planus, discoid lupus erythematosus, and
other
skin conditions which do not respond satisfactorily to less active
steroids
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply sparingly to the affected area once or twice daily until
improvement
occurs. As with other highly active topical steroid preparations,
therapy should
be discontinued when control is achieved. In the more responsive
conditions
this may be within a few days.
If no improvement is seen within two to four weeks, reassessment of
the
diagnosis, or referral, may be necessary.
Repeated short courses of Clobetasol Propionate Cream may be used to
control exacerbations. If continuous steroid treatment is necessary, a
less
potent preparation should be used.
In very resistant lesions, especially where there is hyperkeratosis,
the anti-
inflammatory effect of Clobetasol Propionate Cream can be enhanced, if
necessary, by occluding the treatment area with polythene film.
Overnight
occlusion only is usually adequate to bring about a satisfactory
response.
Thereafter improvement can usually be maintained by application
without
occlusion.
For topical administration.
4.3
CONTRAINDICATIONS
•
Rosacea
•
Acne vulgaris
•
Perioral dermatitis
•
Perianal and genital pruritus
•
Primary cutaneous viral infections (e.g. herpes simp