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BETAMETHASONE VALERATE 0.1%W/W CREAM

Active substance(s): BETAMETHASONE VALERATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Betamethasone Valerate 0.1%w/w Cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
0.1% betamethasone B.P. as the valerate ester

3.

PHARMACEUTICAL FORM
Cream.

4.

Clinical Particulars

4.1

Therapeutic indications
Severe inflammatory skin disorders such as eczema in patients unresponsive to less
potent corticosteroids.

4.2 Posology and method of administration
Route of administration: Cutaneous
Creams are especially appropriate for moist or weeping surfaces.
Apply thinly and gently rub in using only enough to cover the entire affected area once or
twice daily for up to 4 weeks 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.
In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees,
the effect of betamethasone valerate 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 in such lesions; thereafter, improvement can usually be
maintained by regular application without occlusion.
If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis
should be re-evaluated.
Therapy with betamethasone valerate 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 betamethasone
valerate.
Recalcitrant dermatoses
Patients who frequently relapse
Once an acute episode has been treated effectively with a continuous course of topical
corticosteroid, intermittent dosing (apply once a day twice a week without occlusion) may be
considered. This has been shown to be helpful in reducing the frequency of relapse.
Application should be continued to all previously affected sites or to known sites of potential
relapse. This regimen should be combined with routine daily use of emollients. The condition
and the benefits and risks of continued treatment must be re-evaluated on a regular basis.
Paediatric population
Betamethasone valerate is contraindicated in children under one year of age.
Children are more likely to develop local and systemic side effects of topical corticosteroids
and, in general, require shorter courses and less potent agents than adults; therefore, courses
should be limited to five days and occlusion should not be used.
Care should be taken when using betamethasone valerate to ensure the amount applied is the
minimum that provides therapeutic benefit.
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 any of the excipients listed in section 6.1.
The following conditions should not be treated with betamethasone valerate:
-Untreated cutaneous infections
-Rosacea
-Acne vulgaris
-Pruritus without inflammation
-Perianal and genital pruritus
-Perioral dermatitis
Betamethasone valerate is contraindicated in dermatoses in infants under one year of age,
including dermatitis
4.4

Special Warnings And Special Precautions For Use

Hypersensitivity reactions
Betamethasone valerate 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.
Systemic effects
Long-term continuous topical therapy should be avoided where possible, particularly
in infants and children, as reversible hypothalamic-pituitary-adrenal (HPA)
suppression leading to glucocorticoid insufficiency, with or without clinical features
of Cushing’s syndrome/hypercortisolism, can occur even without occlusion. In this
situation, topical steroids should be discontinued gradually under medical supervision
because of the risk of adrenal insufficiency (see sections 4.8 and 4.9).
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 may act 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 may absorb proportionally larger amounts of
topical corticosteroids and thus be more susceptible to systemic adverse effects. This
is because children have an immature skin barrier and a greater surface area to body
weight ratio compared with adults.
Use in psoriasis
Topical corticosteroids should be avoided or given only under specialist supervision
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.
Application to the face or eyelids
Topical corticosteroids may cause skin atrophy, especially on thin skin areas such as
the face or flexures, and may cause acne or perioral dermatitis when used on the face.
Potent steroids such as betamethasone valerate 0.1% should not be applied to the face
unless the patient is under specialist supervision.
If used on the face, courses should be limited to five days.
If applied to the eyelids, care is needed to ensure that the preparation does not enter
the eye, as glaucoma might result.

Paediatric population
If used in childhood, courses should be limited to five days and occlusion should not
be used (see below). Long-term continuous topical corticosteroid therapy should be

avoided where possible as adrenal suppression can occur.
Use with occlusive dressings
Use of occlusive dressings, including nappies on infants, increase absorption of
topical corticosteroids, with increased risk of systemic side effects (see also
Concomitant infection).
Concomitant infection
Appropriate antimicrobial therapy should be used whenever treating inflammatory
lesions that 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.
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 incidence of local
hypersensitivity reactions and an increased risk of local infection.
Potency
The least potent corticosteroid that will control the disease should be selected.
4.5

Interactions with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of
corticosteroids to pregnant animals can cause abnormalities of foetal development including
cleft palate and intra-uterine growth retardation. There may be a very small risk of such
effects in the human foetus, and it is therefore advisable to avoid the extensive use of
betamethasone in pregnancy.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable Effects
Adverse events are listed below by system organ class and frequency. Frequencies are
defined as: very common ( ≥ 1/10), common ( ≥ 1/100 and < 1/10), uncommon ( ≥
1/1000 and < 1/100), rare ( ≥ 1/10,000 and < 1/1000) and very rare ( < 1/10,000)
including isolated reports.

Infections and infestations
Very rare: Opportunistic infection
Immune system disorders:
Very rare: Hypersensitivity, generalised rash.
If signs of hypersensitivity appear, application should stop immediately.
Endocrine disorders:
Very rare: Features of Cushing’s syndrome (moon face, central obesity, delayed
weight gain/growth retardation in children, osteoporosis, hyperglycaemia/glycosuria,
glaucoma, cataract, hypertension, increased weight/obesity, decreased endogenous
cortisol levels, alopecia, trichorrhexia).
.
As with other topical corticosteroids, prolonged use of large amounts or treatment of
extensive areas can result in sufficient systemic absorption to produce suppression of
the hypothalamic-pituitary-adrenal axis and the clinical features of Cushing’s
syndrome (see section 4.4). These effects are more likely to occur in infants and
children, and if occlusive dressings are used. In infants the nappy may act as an
occlusive dressing.
Eye disorders:
Rare cases of glaucoma have been reported following the use of topical steroids in the
periorbital region (see section 4.4).
Skin and subcutaneous tissue disorders:
Common: Local skin burning and pruritus.
Very rare: Local atrophic changes in the skin such as thinning, irreversible striae or
telangiectasia may be caused by prolonged and intensive treatment with potent
corticosteroid preparations, particularly when occlusive dressings are used or when
skin folds are involved.
Allergic contact dermatitis/dermatitis, erythema, rash, urticaria, perioral dermatitis or
acne, hypertrichosis, pigmentation changes and exacerbation of underlying symptoms
have also been reported.
In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is
thought to have provoked the pustular form of the disease (see section 4.4).
Reporting of suspected reactions:
Reporting 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
Acute overdose is very unlikely to occur. However, in the case of chronic overdose or
misuse the features of Cushing’s syndrome may appear and in this situation topical

steroids should be discontinued gradually under medical supervision (see section 4.4).
5.1 Pharmacodynamic properties
ATC code
D07AC Corticosteroids, potent (group III)
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.
5.2 Pharmacokinetic properties
Absorption
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.
Distribution
The use of pharmacodynamic endpoints for assessing the systemic exposure of topical
corticosteroids is necessary because 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
Reproductive toxicity
Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥0.1
mg/kg/day or rabbits at doses ≥12 micrograms/kg/day during pregnancy produced foetal
abnormalities including cleft palate and intrauterine growth retardation.
The effect on fertility of betamethasone valerate has not been evaluated in animals.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Chlorocresol, liquid paraffin, cetostearyl alcohol, cetomacrogol 1000, propylene
glycol, sodium phosphate, citric acid and purified water.
6.2

Incompatibilities
None.

6.3

Shelf life
Two (2) years.

6.4

Special precautions for storage
Do not store above 25ºC. Store in the original container.

6.5

Nature and contents of container
Tubes containing 5g, 15g or 30g, or 100g
Polypropylene jars containing 100 or 500g.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Manx Healthcare Limited
Taylor Group House
Wedgnock Lane
Warwick
CV34 5YA
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 14251/0009

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27 November 1998/21 December 2010

10

DATE OF REVISION OF THE TEXT
04/04/2014

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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.

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