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BETNOVATE OINTMENT

Active substance(s): BETAMETHASONE VALERATE / BETAMETHASONE VALERATE

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1.

NAME OF THE MEDICINAL PRODUCT
Betnovate Ointment

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone Valerate B.P. 0.122% w/w
For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Betamethasone valerate is a potent topical corticosteroid indicated for adults,
elderly and children over 1 year for the relief of the inflammatory and pruritic
manifestations of steroid responsive dermatoses. These include the following:
Atopic dermatitis (including infantile atopic dermatitis)
Nummular dermatitis (discoid eczema)
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Lichen simplex chronicus (neurodermatitis) and lichen planus
Seborrhoeic dermatitis
Irritant or allergic contact dermatitis
Discoid lupus erythematosus
Adjunct to systemic steroid therapy in generalised erythroderma
Insect bite reactions

4.2

Posology and method of administration

Route of administration: Cutaneous
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 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 precautions for use
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.
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:
o Potency and formulation of topical steroid
o Duration of exposure
o Application to a large surface area

o 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)
o Increasing hydration of the stratum corneum
o Use on thin skin areas such as the face
o Use on broken skin or other conditions where the skin barrier may be
impaired
o 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.
Paediatric population
In infants and children under 12 years of age, treatment courses should be
limited to five days and occlusion should not be used; long-term continuous
topical corticosteroid therapy should be avoided where possible, as adrenal
suppression can 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.
Use in Psoriasis
Topical corticosteroids should be used with caution in psoriasis as rebound
relapses, development of tolerances, risk of generalised pustular psoriasis and
development of local or systemic toxicity due to impaired barrier function of
the skin have been reported in some cases. If used in psoriasis careful patient
supervision is important.
Application to the face
Prolonged application to the face is undesirable as this area is more susceptible
to atrophic changes; therefore, treatment courses should be limited to five days
and occlusion should not be used.
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.
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.

4.5

Interaction with other medicinal products 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
Fertility
There are no data in humans to evaluate the effect of topical corticosteroids on
fertility.
Pregnancy
There are limited data from the use of betamethasone valerate 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; however,
administration of betamethasone valerate 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.
Lactation
The safe use of topical corticosteroids during lactation has not been
established.
It is not known whether topical administration of corticosteroids could result
in sufficient systemic absorption to produce detectable amounts in breast milk.
Administration of betamethasone valerate during lactation should only be
considered if the expected benefit to the mother outweighs the risk to the
infant.
If used during lactation betamethasone valerate should not be applied to the
breasts to avoid accidental ingestion by the infant.

4.7

Effects on ability to drive and use machines
There have been no studies to investigate the effect of betamethasone valerate
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 betamethasone valerate.

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, alopecia,
trichorrhexis
Skin and Subcutaneous Tissue Disorders
Common

Pruritus, local skin burning /skin pain

Very rare

Allergic contact dermatitis /dermatitis,
erythema, rash, urticaria, pustular psoriasis, skin
thinning* / skin atrophy*, skin wrinkling*, skin
dryness*, striae*, telangiectasias*, pigmentation
changes*, hypertrichosis, exacerbation of
underlying symptoms

General Disorders and Administration Site Conditions
Very rare

Application site irritation/pain

*Skin features secondary to local and/or systemic effects of hypothalamicpituitary adrenal (HPA) axis suppression.
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
Symptoms and signs
Topically applied betamethasone valerate 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, betamethasone valerate 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
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
Liquid Paraffin
White Soft Paraffin

6.2

BP
BP

Incompatibilities
None known.

6.3

Shelf-Life
Tubes: 36 months
Pump Dispenser:

6.4

24 months

Special Precautions for Storage

Tubes: Store below 30οC
Pumps: Store below 25οC

6.5

Nature and Content of Container

30 gm and 100 gm collapsible aluminium tubes internally coated with an
epoxy resin based lacquer and closed with a polypropylene cap.
100 gm polypropylene/polyethylene pump dispenser with natural (translucent)
polypropylene body. The nozzle is sealed with a polyethylene acetyl tab.
The pump is closed with an opaque polypropylene overcap and overwrapped
with an opaque shrink-wrap.
Not all pack sizes may be marketed

6.6

Special precautions for disposal
No special requirements.

7.

MARKETING AUTHORISATION HOLDER
Glaxo Wellcome UK Limited
T/A Glaxo Laboratories and/or GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

8.

MARKETING AUTHORISATION NUMBER(S)
PL 10949/0020

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/09/2007

10

DATE OF REVISION OF THE TEXT
13 September 2013

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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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