Skip to Content

CLOBADERM 0.05% W/W CREAM

Active substance(s): CLOBETASOL PROPIONATE / CLOBETASOL PROPIONATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
ClobaDerm 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 ClobaDerm 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 antiinflammatory effect of ClobaDerm 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



Acne vulgaris



Perioral dermatitis



Perianal and genital pruritus



Primary cutaneous viral infections (e.g. herpes simplex, chickenpox)



Hypersensitivity to the preparation



4.4

Rosacea

The use of ClobaDerm skin preparations is not indicated in the treatment of
primary infected skin lesions caused by infection with fungi (e.g. candidiasis,
tinea) or bacteria (e.g. impetigo); or dermatoses in children under one year of age,
including dermatitis and napkin eruptions.

Special warnings and precautions for use
Long-term continuous therapy should be avoided where possible, particularly in
infants and children, as adrenal suppression can occur even without occlusion. If
ClobaDerm is required for use in children, it is recommended that the treatment
should be reviewed weekly. It should be noted that the infant's napkin may act as an
occlusive dressing.
If used in childhood or on the face, courses should be limited if possible to five days
and occlusion should not be used.
The face, more than other areas of the body, may exhibit atrophic changes after
prolonged treatment with potent topical corticosteroids. This must be borne in mind

when treating such conditions as psoriasis, discoid lupus erythematosus and severe
eczema.
If applied to the eyelids, care is needed to ensure that the preparation does not enter
the eye, as glaucoma might result. If ClobaDerm does enter the eye, the affected eye
should be bathed in copious amounts of water.
Topical steroids may be hazardous in psoriasis for a number of reasons including
rebound relapses, development of tolerance, risk of generalised pustular psoriasis and
development of local or systemic toxicity due to impaired barrier function of the skin.
If used in psoriasis careful patient supervision is important.
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.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive
dressings, and so the skin should be cleansed before a fresh dressing is applied.
There have been a few reports in the literature of the development of cataracts in
patients who have been using corticosteroids for prolonged periods of time. Although
it is not possible to rule out systemic corticosteroids as a known factor, prescribers
should be aware of the possible role of corticosteroids in cataract development.
ClobaDerm 0.05% w/w Cream contains cetostearyl alcohol which can cause local
skin reactions (e.g. contact dermatitis), propylene glycol which may cause skin
irritation and chlorocresol which may cause allergic reactions.

4.5

Interaction with other medicinal products and other forms of interaction
None reported.

4.6

Fertility, pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Topical administration of
corticosteroids to pregnant animals can cause abnormalities of fetal development
including cleft palate and intrauterine growth retardation. The relevance of this
finding to humans has not been established, therefore, topical steroids should not be
used extensively in pregnancy, i.e. in large amounts or for prolonged periods.
The safe use of clobetasol propionate during lactation has not been established.

4.7

Effects on ability to drive and use machines
ClobaDerm is not expected to have any effects.

4.8

Undesirable effects
The following adverse reactions have been identified during post-approval use of
clobetasol propionate. Because these reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure. The frequency of these
adverse events has therefore been classified as “unknown”.

Immune system disorders
Hypersensitivity
Local hypersensitivity reactions such as erythema, rash, pruritus, urticaria and
allergic contact dermatitis may occur at the site of application and may
resemble symptoms of the condition under treatment.
If signs of hypersensitivity appear, application should be stopped
immediately.
Endocrine disorders
Features of Cushing's syndrome
As with other topical corticosteroids, prolonged use of large amounts, or
treatment of extensive areas can result in sufficient systemic absorption to
produce the features of Cushing's syndrome. This effect is more likely to
occur in infants and children, and if occlusive dressings are used. In infants,
the nappy may act as an occlusive dressing.
Provided the weekly dosage is less than 50g in adults, any suppression of the
HPA axis is likely to be transient with a rapid return to normal values once
the short course of steroid therapy has ceased. The same applies to children
given proportionate dosage.
Vascular disorders
Dilatation of the superficial blood vessels
Prolonged and intensive treatment with highly-active corticosteroid
preparations may cause dilatation of the superficial blood vessels, particularly
when occlusive dressings are used, or when skin folds are involved.

Skin and subcutaneous tissue disorders
Local skin burning, local atrophy, striae, thinning, pigmentation changes,
hypertrichosis, exacerbation of underlying symptoms, pustular psoriasis.
Prolonged and intensive treatment with highly-active corticosteroid
preparations may cause local atrophic changes, such as thinning and striae.

Treatment of psoriasis with corticosteroids (or its withdrawal) is thought to
have provoked the pustular form of the disease.

4.9

Overdose
Acute overdosage is very unlikely to occur, however, in the case of chronic
overdosage or misuse, the features of hypercortisolism may appear and in this
situation topical steroids should be reduced or discontinued gradually, under medical
supervision.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Clobetasol propionate is a highly active corticosteroid with topical anti-inflammatory
activity. The major effect of clobetasol propionate on skin is a non-specific antiinflammatory response, partially due to vasoconstriction and decrease in collagen
synthesis.

5.2

Pharmacokinetic properties
Percutaneous penetration of clobetasol propionate varies among individuals and can
be increased by the use of occlusive dressings, or when the skin is inflamed or
diseased.
Mean peak plasma clobetasol propionate concentrations of 0.63 ng/ml occurred in
one study eight hours after the second application (13 hours after an initial
application) of 30 g clobetasol propionate 0.05% ointment to normal individuals with
healthy skin. Following the application of a second dose of 30 g clobetasol propionate
cream 0.05% mean peak plasma concentrations were slightly higher than the ointment
and occurred 10 hours after application.
In a separate study, mean peak plasma concentrations of approximately 2.3 ng/ml and
4.6 ng/ml occurred respectively in patients with psoriasis and eczema three hours
after a single application of 25 g clobetasol propionate 0.05% ointment.
Following percutaneous absorption of clobetasol propionate, the drug probably
follows the metabolic pathway of systemically administered corticosteroids, i.e.
metabolised primarily by the liver and then excreted by the kidneys. However,
systemic metabolism of clobetasol has never been fully characterised or quantified.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to
that in other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Cetostearyl alcohol
Glycerol monostearate
Arlacel 165 (glycerol monostearate & macrogol 100 stearate)
White beeswax
Propylene glycol
Chlorocresol
Sodium citrate
Citric acid monohydrate
Purified water

6.2

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed
with other medicinal products.

6.3

Shelf life
2 years.
In-use shelf life: 3 months

6.4

Special precautions for storage
Store below 30 °C.

6.5

Nature and contents of container
Collapsible aluminum tubes internally coated with an epoxy resin based lacquer and
closed with a polypropylene cap.

Pack sizes: 30g or 100g.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Patients should be advised to wash their hands after applying ClobaDerm unless it is
the hands that are being treated.

7

MARKETING AUTHORISATION HOLDER
Auden Mckenzie (Pharma Division) Ltd
McKenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 17507/0109

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21/06/2012

10

DATE OF REVISION OF THE TEXT
21/06/2012

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide