We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

GlaxoSmithKline (Ireland) Ltd

Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: 1 800 244 255
Medical Information Facsimile: +353 1 495 5242


Summary of Product Characteristics last updated on medicines.ie: 20/02/2013
SPC Betnovate RD Ointment



Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Betnovate RD (Ready Diluted) 0.025% w/w Ointment


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone 0.025% w/w (as Betamethasone valerate).

For a full list of excipients, see section 6.1


Go to top of the page
3. PHARMACEUTICAL FORM

Ointment.

A smooth, off-white soft-paraffin based ointment


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

Betamethasone is indicated in the topical management of corticosteroid responsive dermatoses such as eczema in children and adults, including atopic and discoid eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), neurodermatoses, including lichen simplex, lichen planus, seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and may be used as an adjunct to systemic steroid therapy in generalized erythroderma insect bite reactions and prickly heat..

Betamethasone Valerate is a potent glucocorticoid absorbed in part after topical use. Betnovate RD preparations are indicated for maintenance treatment when control has been achieved with Betnovate.


Go to top of the page
4.2 Posology and method of administration

Application to the affected area usually one to three times daily, or as directed by the physician.

When improvement occurs frequency of use should be gradually reduced.

Administration in Children

Care should be taken when using betamethasone valerate to ensure the amount applied is the minimum that provides therapeutic benefit.

Administration in the Elderly

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Administration in Renal/Hepatic Impairment

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit

Betnovate RD ointment is especially appropriate for dry, lichenified or scaly lesions, but this is not invariably so.


Go to top of the page
4.3 Contraindications

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

• Widespread plaque psoriasis

Betamethasone valerate is contraindicated in dermatoses in infants under one year of age, including dermatitis.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.


Go to top of the page
4.4 Special warnings and precautions for use

Betamethasone valerate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see Adverse Reaction) 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 Adverse Reactions).

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)

• 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.

Children

Prolonged use of uninterrupted occlusion (including nappies) or use with extensive occlusive dressing may suppress adrenocortical function. 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. Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression or of growth suppression, systemic absorption and hypercorticism.

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 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.

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.

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.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

Co-administered drugs that can inhibit CYP3A4 (e.g. Ritonavir and 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.


Go to top of the page
4.6 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 Non-clinical Information). 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 breasts to avoid accidental ingestion by the infant.


Go to top of the page
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.


Go to top of the page
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.

Post-marketing data

Infections and Infestations

Very rare

Opportunistic infection

Immune System Disorders

Very rare

Local hypersensitivity

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

* Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

General Disorders and Administration Site Conditions

Very rare

Application site irritation/pain


Go to top of the page
4.9 Overdose

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may occur (See Adverse Reactions). 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.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

Betamethasone valerate is a corticosteroid with topical anti-inflammatory activity.


Go to top of the page
5.2 Pharmacokinetic properties

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings on the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.


Go to top of the page
5.3 Preclinical safety data

No additional data.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipient(s)

White Soft Paraffin,

Liquid Paraffin.


Go to top of the page
6.2 Incompatibilities

Not applicable


Go to top of the page
6.3 Shelf life

3 years.


Go to top of the page
6.4 Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.


Go to top of the page
6.5 Nature and contents of container

Betnovate RD ointment is supplied in 100g collapsible aluminium tubes.


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline (Ireland) Limited,

Stonemasons Way,

Rathfarnham,

Dublin 16

Ireland


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 1077/1/5


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24th August 1984

Date of last renewal: 24th August 2009


Go to top of the page
10. DATE OF REVISION OF THE TEXT

February 2013



Link to this document from your website:
http://www.medicines.ie/medicine/2206/SPC/Betnovate+RD+Ointment/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Active Ingredients

 
   Betamethasone Valerate