NEW ZEALAND DATA SHEET

1. PRODUCT NAME

BETNOVATE betamethasone valerate 0.122% w/w lotion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone valerate 0.122% w/w (equivalent to betamethasone 0.1% w/w)

For full list of excipients, see section 6.1 List of excipients.

3. PHARMACEUTICAL FORM

Lotion

BETNOVATE Lotion, a white, translucent, aqueous fluid.

4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
BETNOVATE Lotion 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
• Insect bite reactions
• Miliaria (prickly heat); and
• Adjunct to systemic steroid therapy in generalised erythroderma.

4.2 Dose and method of administration

Dose
Adults, Elderly and Children over 1 year
BETNOVATE Lotion is especially appropriate for treatment of hairy areas or when a
minimal application to a large area is required.

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.

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In the more resistant lesions, such as the thickened plaques of psoriasis on the
elbows and knees, the effect of BETNOVATE Lotion 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.

Due to the flammable nature of BETNOVATE Lotion, patients should avoid smoking
or being near an open flame during application and immediately after use.

Atopic dermatitis (eczema)

Therapy with BETNOVATE Lotion 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

BETNOVATE Lotion.

Recalcitrant dermatoses
Patients who frequently relapse

Once an acute episode has been treated effectively with a continuous course of
topical corticosteroid, intermittent dosing (once daily, twice weekly, 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 regime 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.

Children aged 1 year and over

BETNOVATE Lotion is contraindicated in children under one year of age (see section
4.3 Contraindications).

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.

Care should be taken when using BETNOVATE Lotion 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

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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
The following conditions should not be treated with BETNOVATE Lotion:

• Untreated cutaneous infections

• Rosacea
• Acne vulgaris
• Pruritus without inflammation
• Perianal and genital pruritus
• Hypersensitivity to the preparations.
• Perioral dermatitis

BETNOVATE Lotion is contraindicated in dermatoses in infants under one year of

age, including dermatitis.

4.4 Special warnings and precautions for use

Hypersensitivity

BETNOVATE should not be used in patients with a history of local hypersensitivity to

corticosteroids or to any of the excipients in the preparation. Local hypersensitivity
reactions (see section 4.8 Undesirable effects) may resemble symptoms of the
condition under treatment.

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression

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 Undesirable effects).

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.

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Visual disturbance has been reported by patients using systemic and /or topical
corticosteroids. If a patient has blurred vision or other visual disturbances, consider
evaluation of possible causes which may include cataract, glaucoma or central
serous chorioretinopathy.

Paediatric population

In infants and children under 12 years of age, 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.

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.

Flammability Risk

Product contains paraffin. Instruct patients not to smoke or go near naked flames due
to the risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in
contact with this product burns more easily and is a serious fire hazard. Washing
clothing and bedding may reduce product build-up but not totally remove it.

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4.5 Interaction with other medicines 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 betamethasone valerate in pregnant women.

Topical administration of corticosteroids to pregnant animals can cause abnormalities

of foetal development.

The relevance of this finding to humans has not been established; however,
administration of BETNOVATE Lotion 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 topical administration of corticosteroids could result in

sufficient systemic absorption to produce detectable amounts in breast milk.
Administration of BETNOVATE Lotion during lactation should only be considered if
the expected benefit to the mother outweighs the risk to the infant.

If used during lactation BETNOVATE Lotion should not be applied to the beasts 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 BETNOVATE Lotion on
driving performance or the ability to operate machinery. A detrimental effect on such
activities would not be anticipated from the adverse effects profile of BETNOVATE
Lotion.

4.8 Undesirable effects

Adverse drug reactions 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 (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very
rare (<1/10,000) including isolated reports.

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Post-marketing data

Infections and Infestations

Very rare: Opportunistic infection

Immune system disorders

Very rare: Local hypersensitivity

Endocrine disorders
Very rare: Hypothalamic-pituitaryadrenal (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 HPA axis

suppression.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is

important. It allows continued monitoring of the benefit/risk balance of the medicine.
Healthcare professionals are asked to report any suspected adverse reactions via:
https://nzphvc.otago.ac.nz/reporting/

4.9 Overdose
Symptoms and Signs

Topically applied betamethasone valerate may be absorbed in sufficient amounts to

produce systemic effects. Acute overdosage is unlikely to occur, however, in the
case of chronic overdosage or misuse, the features of hypercortisolism may occur
(see section 4.8 Undesirable effects).

Treatment

In the event of overdose, BETNOVATE Lotion should be withdrawn gradually by

reducing the frequency of application, or by substituting a less potent corticosteroid
because of the risk of glucocorticosteroid insufficiency.

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For advice on the management of overdose please contact the National Poisons
Centre on 0800 POISON (0800 764 766).

5. PHARMACOLOGICAL PROPERTIES
The least potent corticosteroid which will control the disease should be selected.

5.1 Pharmacodynamic properties

ATC code: D07AC Corticosteroids, potent (group III)

Chemical Structure

Betamethasone valerate

O
OH
H3C
HO OCO[CH2]3CH3
H3C CH3
H

F H
O

Mechanism of action

Betamethasone valerate is an active topical corticosteroid which produces a rapid

response in those inflammatory dermatoses that are normally responsive to topical
corticosteroid therapy, and is often effective in the less responsive conditions such as
psoriasis.

Pharmacodynamic effects

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive

properties.

5.2 Pharmacokinetic properties

Absorption

As with other topical corticosteroids, sufficient betamethasone valerate may be

absorbed to give systemic effects if applied under an occlusive dressing or when the
skin is broken.

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.

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Biotransformation

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

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

BETNOVATE Lotion also contains:

• methyl hydroxybenzoate
• xanthan gum
• cetostearyl alcohol
• liquid paraffin (see Section 4.4 Special warnings and precautions for use)
• isopropyl alcohol
• glycerol
• cetomacrogol 1000
• sodium citrate
• citric acid monohydrate
• purified water

BETNOVATE Lotion does not contain lanolin.

BETNOVATE Lotion contains parabens.

6.2 Incompatibilities

No incompatibilities have been identified.

6.3 Shelf life

3 years

In-use shelf life

Discard 3 months after opening.

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6.4 Special precautions for storage

Store below 25°C, out of direct sunlight.

Keep container tightly closed when not in use. Contents are flammable. Keep away
from fire, flame or heat.

6.5 Nature and contents of container

BETNOVATE Lotion is supplied in white opaque 50 mL HDPE bottle.

6.6 Special precautions for disposal and other handling

There are no special requirements for handling of this product. Any unused medicine
should be disposed of in accordance with local requirements.

There are no special requirements for disposal.

7. MEDICINE SCHEDULE
Prescription Medicine

8. SPONSOR
GlaxoSmithKline NZ Limited
Private Bag 106600
Downtown Auckland
New Zealand

Phone: (09) 367 2900

Facsimile: (09) 367 2910

9. DATE OF FIRST APPROVAL

Date of publication in the New Zealand Gazette of consent to distribute the medicine:
27 January 1964

10 DATE OF REVISION OF THE TEXT

23 July 2020

Summary table of changes:

Section changed Summary of new information
4.4 Added warning for flammability risk
6.1 Referenced Section 4.4 Special warnings and precautions
for use.

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Version: 7.0

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© 2020 GSK group of companies or its licensor.

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