Skip to Content

EUMOVATE OINTMENT

Active substance(s): CLOBETASONE BUTYRATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Eumovate Ointment

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
0.05% w/w clobetasone butyrate.

3

PHARMACEUTICAL FORM
Paraffin based ointment.

4

CLINICAL PARTICULARDS

4.1

Therapeutic Indications
Eumovate ointment is a moderately potent topical corticosteroid indicated for adults,
elderly, children and infants for the relief of the inflammatory and pruritic
manifestations of steroid responsive dermatoses.
These include the following:
- Atopic dermatitis
- Irritant or allergic contact dermatitis
- Seborrhoeic dermatitis
- Nappy rash
- Photodermatitis
- Otitis externa
- Prurigo nodularis
- Insect bite reactions
- Eumovate may be used as maintenance therapy between courses of one of the
more potent topical steroids.

4.2

Posology and method of administration
Route of administration: Cutaneous
Adults, Elderly, Children and Infants
Ointments are especially appropriate for dry, lichenified or scaly lesions.
Apply thinly and gently rub in using only enough to cover the entire affected area
once or twice a day until improvement occurs, then reduce the frequency of
application or change the treatment to a less potent preparation. Allow adequate time
for absorption after each application before applying an emollient.
Therapy with topical corticosteroids should be gradually discontinued once control is
achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical
corticosteroids especially with potent preparations.
Duration of treatment for adults and elderly
Continuous daily treatment for longer than four weeks is not recommended. If the
condition worsens or does not improve within four weeks, treatment and diagnosis
should be re-evaluated.
Paediatric population
Use in children under 12 years should be on the advice of a doctor.
Care should be taken when using clobetasone to ensure the amount applied is the
minimum that provides therapeutic benefit.
Duration of treatment for children and infants
When clobetasone is used in the treatment of dermatoses in children, extreme caution
is required and treatment should not normally exceed 7 days.
If the condition worsens or does not improve within 7 days, treatment should be
reviewed.
Once the condition has been controlled, the frequency of application should be
reduced to the lowest effective dose for the shortest time possible.
Continuous daily treatment for longer than four weeks is not recommended in
children.
Elderly
Clinical studies have not identified differences in responses between the elderly and
younger patients. The greater frequency of decreased hepatic or renal function in the
elderly may delay elimination if systemic absorption occurs. Therefore the minimum
quantity should be used for the shortest duration to achieve the desired clinical
benefit.
Renal / Hepatic Impairment
In case of systemic absorption (when application is over a large surface area for a
prolonged period) metabolism and elimination may be delayed therefore increasing
the risk of systemic toxicity. Therefore the minimum quantity should be used for the
shortest duration to achieve the desired clinical benefit.

4.3

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section
6.1.
The following conditions should not be treated with Eumovate:
• Untreated cutaneous infections.
• Rosacea
• Acne vulgaris
• Pruritus without inflammation.

4.4

Special warnings and precautions for use
Eumovate should be used with caution in patients with a history of local
hypersensitivity to other corticosteroids. Local hypersensitivity reactions (see
section 4.8) may resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing’s syndrome) and reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to
glucocorticosteroid insufficiency can occur in some individuals as a result of
increased systemic absorption of topical steroids. If either of the above are
observed, withdraw the drug gradually by reducing the frequency of
application or by substituting a less potent corticosteroid. Abrupt withdrawal
of treatment may result in glucocorticosteroid insufficiency (see section 4.8).
Risk factors for increased systemic effects are:
• Potency and formulation of topical steroid
• Duration of exposure
• Application to a large surface area
• Use on occluded areas of skin e.g. on intertriginous areas or under
occlusive dressings (in infants the nappy can be considered as an
occlusive dressing).
• Increasing hydration of the stratum corneum
• Use on thin skin areas such as the face
• Use on broken skin or other conditions where the skin barrier may be
impaired
• In comparison with adults, children and infants may absorb
proportionally larger amounts of topical corticosteroids and thus be
more susceptible to systemic adverse effects.
Paediatric population
Children are more likely to develop local and systemic adverse reactions due
to the use of local corticosteroids because of their higher surface area to body
mass ratio and, in general, require a shorter treatment.

Particularly, in infants and toddlers the diaper can be considered as an
occlusive dressing and therefore can enhance absorption
In infants and children under 12 years of age, long-term continuous topical
corticosteroid therapy should be avoided where possible, as adrenal and
growth suppression is more likely to occur.
Infection risk with occlusion
Bacterial infection is encouraged by the warm, moist conditions within skin
folds or caused by occlusive dressings. When using occlusive dressings, the
skin should be cleansed before a fresh dressing is applied.
Application to the face
Prolonged application to the face is undesirable as this area is more susceptible
to atrophic changes.
Application to the eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not
enter the eye, as cataract and glaucoma might result from repeated exposure.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid
use. If a patient presents with symptoms such as blurred vision or other visual
disturbances, the patient should be considered for referral to an
ophthalmologist for evaluation of possible causes which may include cataract,
glaucoma or rare diseases such as central serous chorioretinopathy (CSCR)
which have been reported after use of systemic and topical corticosteroids.
Concomitant infection
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 administration of
appropriate antimicrobial therapy.
Chronic leg ulcers
Topical corticosteroids are sometimes used to treat the dermatitis around
chronic leg ulcers. However, this use may be associated with a higher
occurrence of local hypersensitivity reactions and an increased risk of local
infection.
Accidental ingestion
For external use only. This and all medication should be kept out of the reach
of children. In case of accidental ingestion, professional assistance should be
sought or a national poison control centre contacted immediately (see section
4.9).
Healthcare professionals should be aware that if this product comes into
contact with dressings, clothing and bedding, the fabric can be easily ignited
with a naked flame. Patients should be warned of this risk and advised to keep
away from fire when using this product.

4.5

Interactions with other Medicaments and other forms of Interaction

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole)
have been shown to inhibit the metabolism of corticosteroids leading to
increased systemic exposure. The extent to which this interaction is clinically
relevant depends on the dose and route of administration of the corticosteroids
and the potency of the CYP3A4 inhibitor.
4.6.

Fertility, pregnancy and lactation
Pregnancy
There are limited data from the use of clobetasone in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause
abnormalities of foetal development (see section 5.3).
The relevance of this finding to humans has not been established.
Administration of clobetasone during pregnancy should only be considered if
the expected benefit to the mother outweighs the risk to the foetus. The
minimum quantity should be used for the minimum duration.
Breast-feeding
The safe use of topical corticosteroids during lactation has not been
established.
It is not known whether the topical administration of corticosteroids could
result in sufficient systemic absorption to produce detectable amounts in breast
milk.
Administration of clobetasone during lactation should only be considered if
the expected benefit to the mother outweighs the risk to the infant.
If used during lactation, clobetasone should not be applied to the breasts to
avoid accidental ingestion by the infant.
Fertility
There are no data in humans to evaluate the effect of topical corticosteroids on
fertility.

4.7

Effects on Ability to Drive and Use Machines

There have been no studies to investigate the effect of clobetasone on driving
performance or the ability to operate machinery. A detrimental effect on such
activities would not be anticipated from the adverse reaction profile of topical
clobetasone.
4.8

Undesirable effects

Adverse drug reactions (ADRs) are listed below by MedDRA system organ
class and by frequency. Frequencies are defined as: very common (≥1/10),
common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare
(≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated
reports.
Post-marketing data
Infections and Infestations
Very rare
Opportunistic infection
Immune System Disorders
Very rare
Hypersensitivity, generalised rash
Endocrine Disorders
Very rare
Hypothalamic-pituitary adrenal (HPA) axis suppression:
Cushingoid features (e.g. moon face, central obesity),
delayed weight gain/growth retardation in children,
osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract,
hypertension, increased weight/obesity, decreased
endogenous cortisol levels
Skin and Subcutaneous Tissue Disorders
Very rare
Allergic contact dermatitis, urticaria, skin atrophy*,
pigmentation changes*, exacerbation of underlying
symptoms, local skin burning, hypertrichosis, rash, pruritus,
erythema
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA)

axis suppression.

Eye disorders
Not known

Vision, blurred

Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product
is important. It allows continued monitoring of the benefit/risk balance of the
medicinal product. Healthcare professionals are asked to report any suspected adverse
reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9

Overdose
Symptoms and signs
Topically applied clobetasone may be absorbed in sufficient amounts to
produce systemic effects. Acute overdosage is very unlikely to occur,
however, in the case of chronic overdosage or misuse, the features of
hypercortisolism may occur (see section 4.8).
Treatment
In the event of overdose, clobetasone should be withdrawn gradually by
reducing the frequency of application or by substituting a less potent
corticosteroid because of the risk of glucocorticosteroid insufficiency.

Further management should be as clinically indicated or as recommended by
the national poisons centre, where available.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
ATC code
D07AB Corticosteroids, moderately potent (group II)
Mechanism of action
Topical corticosteroids act as anti-inflammatory agents via multiple
mechanisms to inhibit late phase allergic reactions including decreasing the
density of mast cells, decreasing chemotaxis and activation of eosinophils,
decreasing cytokine production by lymphocytes, monocytes, mast cells and
eosinophils, and inhibiting the metabolism of arachidonic acid.
Pharmacodynamic effects
Topical corticosteroids, have anti-inflammatory, antipruritic and
vasoconstrictive properties.
Clobetasone butyrate has little effect on hypothalamo-pituitary-adrenal
function. This was so even when Eumovate was applied to adults in large
amounts under whole body occlusion.
Clobetasone butyrate is less potent than other available corticosteroid
preparations and has been shown not to suppress the hypothalamo-pituitaryadrenal axis in patients treated for psoriasis or eczema.
Pharmacological studies in man and animals have shown that clobetasone
butyrate has a relatively high level of topical activity accompanied by a low
level of systemic activity.

5.2

Pharmacokinetic Properties
Absorption and Distribution
Topical corticosteroids can be systemically absorbed from intact healthy skin.
The extent of percutaneous absorption of topical corticosteroids is determined
by many factors, including the vehicle and the integrity of the epidermal
barrier. Occlusion, inflammation and/or other disease processes in the skin
may also increase percutaneous absorption.
A single application of 30g clobetasone butyrate 0.05% ointment to eight
patients resulted in a measurable rise in plasma clobetasone butyrate levels
during the first three hours but then the levels gradually decreased. The
maximum plasma level reached in the first three hours was 0.6ng/ml. This rise

in levels was followed by a more gradual decline with plasma levels of
clobetasone butyrate falling below 0.1ng/ml (the lower limit of the assay) after
72 hours. The normal diurnal variation in plasma cortisol levels was not
affected by the application of clobetasone butyrate ointment.
The use of pharmacodynamic endpoints for assessing the systemic exposure of
topical corticosteroids is necessary due to the fact that circulating levels are
well below the level of detection.
Metabolism
Once absorbed through the skin, topical corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered
corticosteroids. They are metabolised, primarily in the liver.
Elimination
Topical corticosteroids are excreted by the kidneys. In addition, some
corticosteroids and their metabolites are also excreted in the bile.
5.3

Preclinical Safety Data
Genotoxicity and Carcinogenesis
Conventional in vitro and in vivo genotoxicity studies reveal no hazard for
humans.
Long-term animal studies have not been performed to evaluate the
carcinogenic potential of topical clobetasone.
Reproductive toxicity
Topical application of clobetasone to rats at doses of 0.5 or 5 mg/kg/day, and
subcutaneous administration to mice at doses ≥3 mg/kg/day or rabbits at doses
≥30 µg/kg/day during pregnancy resulted in foetal abnormalities including
cleft palate, intrauterine growth retardation and foetal loss.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Liquid paraffin
White soft paraffin

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
Collapsible aluminium tube and wadless polypropylene cap.
30 and 100gm tubes are available (25gm pack is also registered).

6.6

Special precautions for disposal and other handling
Patients should be advised to wash their hands after applying Eumovate,
unless it is the hands that are being treated.

7

MARKETING AUTHORISATION HOLDER
Glaxo Wellcome UK Limited
Trading as GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT

8

MARKETING AUTHORISATION NUMBER(S)
PL 10949/0037

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/06/2008

10

DATE OF REVISION OF THE TEXT

02/08/2017

+ 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