BETNEVAL 0,1 % Pom T/30g

Ointment.
Tube of 30 g. 

For 100 g of ointment:

Betamethasone: 0,10 g
as betamethasone valerate

1. Preferred indications where topical corticosteroid therapy is considered the best treatment:

• contact eczema,
• atopic dermatitis.

2. Indications where topical corticosteroid therapy is one of the usual treatments :

• stasis dermatitis,
• psoriasis (excluding very extensive plaques),
• lichen,
• non-parasitic prurigo,
• dyshidrosis,
• genital lichen sclerosus et atrophicus,
• granuloma annulare,
• discoid lupus erythematosus,
• palmoplantar amicrobial pustulosis,
• seborrheic dermatitis with the exception of the face,
• symptomatic treatment of pruritus in mycosis fungoides.

3. Situational indications for a short duration :

• insect bites and parasitic prurigo after etiological treatment.

The ointment form is suitable for dry, squamous lesions.

Note: each dermatosis must be treated with a corticosteroid of the most appropriate level, knowing that depending on the results, one may be led to substitute it with a product of stronger or weaker activity on all or part of the lesions.

Apply once or twice daily as a thin layer to the surface to be treated and work in with gentle massage until the ointment is completely absorbed. Wash hands after application.

An excessive increase in the number of daily applications would risk worsening adverse effects without improving therapeutic effects.

Treatment of large surface areas requires monitoring of the number of tubes used.

Certain dermatoses (psoriasis, atopic dermatitis...) make progressive discontinuation of the topical corticosteroid desirable. This may be achieved by reducing the frequency of applications and/or by using a less potent or less concentrated corticosteroid.

In case of worsening or absence of improvement after 2 to 4 weeks, the treatment and diagnosis must be re-evaluated.

When an acute episode has been effectively treated with continuous topical corticosteroid therapy, intermittent treatment may be considered. In cases of chronic intermittent use, the function of the hypothalamic-pituitary-adrenal axis should be evaluated regularly.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
• Untreated infections.
• Ulcerated lesions.
• Acne.
• Rosacea.
• Perioral dermatitis.

Warnings

Manifestations of hypercorticism (Cushing's syndrome) and reversible inhibition of the hypothalamic-pituitary-adrenal axis, leading to adrenocortical insufficiency, may occur in some subjects due to increased systemic absorption of topical corticosteroids. In either case, the medicine should be discontinued gradually by reducing the frequency of application, or by substituting a corticosteroid of lower potency. Abrupt cessation of treatment may lead to adrenal insufficiency (see Section Adverse effects).

Factors likely to increase systemic effects are as follows:

• Activity and formulation of the topical corticosteroid
• Duration of exposure
• Application over a large area
• Cutaneous application under occlusion (e.g., in intertriginous areas or under an occlusive dressing (in infants, nappies may have the same consequences as an occlusive dressing)
• Increased hydration of the stratum corneum of the skin
• Application on thin skin surfaces such as the face
• Application on skin lesions or other situations involving impaired skin barrier
• Compared with adults, children, particularly infants and young children, may absorb proportionally larger amounts of topical corticosteroids and are therefore more exposed to systemic adverse effects (cushingoid syndrome and growth retardation). This is explained by the fact that children have an immature skin barrier and a larger body surface area to weight ratio compared with adults. These effects disappear upon discontinuation of treatment, but abrupt discontinuation may be followed by acute adrenal insufficiency.

Visual disorders

Visual disturbances may occur with systemic or local corticosteroid therapy. In case of blurred vision or the appearance of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look for cataract, glaucoma, or rarer lesions such as central serous chorioretinopathy, as described with systemic or local administration of corticosteroids.

Precautions for use

Risk of infection under occlusion

In infants, it is preferable to avoid high-activity corticosteroids. Particular caution should be exercised regarding spontaneous occlusion phenomena that may occur in skin folds or under diapers.

Bacterial infection is promoted by heat and moisture present in skin folds or under an occlusive dressing. When using an occlusive dressing, the skin should be cleaned before each dressing change.

Use in psoriasis

Topical corticosteroids should be used with caution in psoriasis, as rebound effects, development of tolerance, a risk of generalised pustular psoriasis and local or systemic toxicity due to impaired skin barrier have been reported in some cases. Use in the treatment of psoriasis requires careful medical supervision.

Application on the face

Prolonged application to the face is not recommended, as this area is more prone to the risk of skin atrophy. Prolonged use of potent corticosteroids on the face exposes patients to the occurrence of corticosteroid-induced and paradoxically corticosteroid-sensitive dermatitis, with rebound after each discontinuation. A gradual withdrawal, which is particularly difficult, is then necessary.

Application to the eyelids

Prolonged application to the eyelids is not recommended due to the risk of cataract and glaucoma. If applied to this area, care should be taken to ensure that the topical corticosteroid does not enter the eye.

Concomitant infection

An appropriate antimicrobial treatment should be used whenever the treated inflammatory lesions become infected. Spread of the infection requires discontinuation of local corticosteroid therapy and administration of appropriate antimicrobial treatment.

Chronic leg ulcers

Topical corticosteroids are sometimes used to treat dermatitis surrounding chronic leg ulcers. This use may be associated with an increase in local hypersensitivity reactions and the risk of local infection.

Risk of flammability

BETNEVAL 0,1 % ointment contains paraffin. Inform your patients not to smoke or approach naked flames because of the risk of severe burns. Fabrics (clothing, bedding, dressings, etc.) that have been in contact with this product burn more easily and may pose a fire risk. Washing clothing and bedding may reduce the buildup of the product, but cannot eliminate it completely.

If local intolerance appears, treatment must be discontinued and the cause must be investigated.

Avoid any contact with the eyes and mucous membranes.

Metabolic disorders such as decreased glucose tolerance are observed with concomitant use of topical corticosteroids and antidiabetic agents. Inform the patient and reinforce blood and urine glucose self-monitoring, especially at the start of treatment.

Pregnancy

Animal studies conducted by the systemic route have shown a teratogenic effect. However, a large number of pregnancies (more than 1 000 pregnancies) exposed systemically to corticosteroids have not shown any malformative or toxic effect of betamethasone valerate on the fetus or newborn. Therefore, the use of BETNEVAL may be considered during pregnancy if necessary.

Breast-feeding

Corticosteroids pass into breast milk after systemic administration. By the topical route, transdermal passage and therefore the risk of excretion of the corticosteroid into milk will depend on the surface area treated, the degree of epidermal alteration and the duration of treatment.

Therefore, given topical use, application of BETNEVAL is possible during breastfeeding.

Prolonged contact of the infant with the treated skin area of the mother should be avoided.

In case of application to the breasts, the skin should be cleansed before each feed in order to avoid accidental ingestion by the infant.

Fertility

Following prenatal exposure to betamethasone valerate by the intramuscular route, a decrease in sperm quality, plasma testosterone level and fertility was observed in male rats. The clinical relevance of these results is not clearly established and is difficult to extrapolate to the cutaneous route.

No study evaluating the effect of betamethasone valerate on the ability to drive vehicles or use machines has been performed. An adverse effect on these activities cannot be anticipated based on the profile of known adverse effects of topical betamethasone valerate.

Adverse effects are listed below according to the MedDRA system organ classification and by frequency. The frequencies are as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data).

Infections and infestations

Frequency not determined: secondary infections, particularly under occlusive dressings or in skin folds, and allergic contact dermatoses have been reported with the use of topical corticosteroids.

Immune system disorders

Frequency not known: local hypersensitivity

Endocrine disorders

Frequency not determined: adrenal insufficiency upon abrupt discontinuation of treatment due to suppression of the hypothalamic-pituitary-adrenal axis.

Cushingoid syndrome (which notably manifests as a moon face and central obesity), and whose skin disorders are: skin atrophy, skin thinning, dry skin, striae, telangiectasia.

Skin and subcutaneous tissue disorders

Common: pruritus, local skin burning

Frequency not known:

Changes in pigmentation, hypertrichosis, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, skin rashes, urticaria.

Prolonged use of potent topical corticosteroids may lead to ecchymotic purpura secondary to skin atrophy, as well as skin fragility.

Allergic contact dermatitis has also been reported with the use of topical corticosteroids. When applied to the face, topical corticosteroids may cause perioral dermatitis or worsen rosacea (see sections Contraindications and Warnings and precautions).

Folliculitis phenomena have been reported.

A delay in healing of atonic wounds, bedsores, and leg ulcers may be observed (see section Contraindications).

General disorders and administration site conditions

Frequency not known: Irritation at the application site

Eye disorders

Frequency not known: blurred vision (see section Warnings and precautions).

Reporting of suspected adverse 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 national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr.

Signs and symptoms

Absorption of topically applied betamethasone valerate may be sufficient to produce systemic effects. Acute overdose is unlikely but, in cases of chronic overdose or misuse, symptoms of hypercorticism may appear (see section Adverse effects).

Treatment

In case of overdose, betamethasone valerate should be discontinued gradually, by reducing the frequency of application or by substituting a less potent topical corticosteroid, due to the risk of adrenal insufficiency.

Pharmacotherapeutic class: Potent corticosteroid (group III), ATC code: D07AC01

Topical corticosteroids are classified into 4 levels of activity according to skin vasoconstriction tests: very strong, strong, moderate, weak activity.

Betamethasone valerate, the active substance of BETNEVAL 0,1 %, ointment, is of strong activity.

Active on certain inflammatory processes (for example: contact hypersensitivity) and the associated pruritic effect. Vasoconstrictor. Inhibits cell proliferation.

Mechanism of action

Topical corticosteroids have anti-inflammatory properties based on multiple mechanisms; they inhibit the late phase of allergic reactions, notably reduce mast cell density, chemotaxis and eosinophil activation, reduce cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibit arachidonic acid metabolism.

Pharmacodynamic effects

Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.

The extent of transdermal passage and systemic effects depends on the size of the treated surface area, the degree of epidermal damage and the duration of treatment. These effects are all the more to be feared the longer the treatment is prolonged.

Absorption

Topical corticosteroids can be absorbed through healthy skin and enter the systemic circulation. The extent of percutaneous absorption of topical corticosteroids depends on various factors, such as the vehicle and the integrity of the epidermal barrier. Occlusive application, inflammation and/or other cutaneous pathological processes may also increase percutaneous absorption.

Certain factors are likely to increase systemic effects (see section Warnings and precautions).

Biotransformation

Once absorbed through the skin, topical corticosteroids follow the same pharmacokinetic pathways as corticosteroids administered systemically. They are metabolised mainly by the liver.

Elimination

Topical corticosteroids are excreted by the kidneys.

No animal study has been carried out to evaluate the carcinogenic potential of betamethasone valerate, the genotoxic potential, or the effect of betamethasone valerate on fertility.

Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥ 0,1 mg/kg/day, and to rabbits at doses ≥ 12 micrograms/kg/day during gestation, resulted in foetal abnormalities, including cleft palate and intrauterine growth retardation.

3 years.

Store at a temperature not exceeding 30 °C.

No special requirements.