Active ingredients: Deoxymethasone
FLUBASON 0.25% cutaneous emulsion
Indications Why is Flubason used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Dermatological corticosteroids.
THERAPEUTIC INDICATIONS
Due to its high anti-inflammatory and anti-itching activity, Flubason is indicated in the treatment of the most important skin diseases of various kinds: allergic dermatitis such as contact dermatitis and eczema, psoriasis.
Contraindications When Flubason should not be used
Hypersensitivity to the active substance, to other corticosteroids or to any of the excipients. Local tuberculous or viral infections (e.g. herpes, chicken pox, etc.), syphilis, vaccinopathies. The Flubason is not for ophthalmic use.
Flubason's lotion contains paraffin which can cause latex condoms to leak or break. Therefore contact between Flubason and latex condom must be avoided.
Pregnancy. Feeding time. Occlusive therapy in subjects with atopic dermatitis.
Precautions for use What you need to know before taking Flubason
Flubason should be given to infants and small children only when clearly needed; this is due to the fact that the risk of systemic effects due to the absorption of glucocorticoids (eg growth retardation) is increased in this age group. In cases where treatment with Flubason is unavoidable, the application should be limited to the minimum dose compatible with therapeutic success and it is advisable to limit the use of the product to short periods of time.
In adults there may be exceptional circumstances in which the use of Flubason over large areas is unavoidable. In such cases the possibility of suppression of the hypothalamic-pituitary-adrenal axis must be considered, particularly with prolonged use. such suppression occurs, it may be necessary to gradually discontinue Flubason.
The topical application of corticosteroids in the treatment of extensive dermatoses and / or for prolonged periods can cause undesirable effects of systemic absorption such as arterial hypertension, asthenia, adynamia, heart rhythm disturbances, hypokalaemia and metabolic alkalosis.
When preparations containing corticosteroids, including Flubason, are repeatedly in contact with the conjunctival sac with topical application, an increase in intraocular pressure may develop over time. Therefore, repeated or prolonged application of Flubason in the immediate vicinity of the eyes it must be preceded by a "careful evaluation of the risk-benefit ratio and must only be carried out under medical supervision.
Interactions Which drugs or foods can change the effect of Flubason
They are not known.
Warnings It is important to know that:
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. If this happens it is necessary to suspend the treatment and institute adequate therapy.
In the presence of skin infections it is necessary to institute suitable antibacterial and antifungal therapy and in case of its failure it is necessary to interrupt the corticosteroid treatment.
The medicinal product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Pregnancy and breastfeeding
The application of Flubason during pregnancy and lactation is contraindicated due to the risk of systemic absorption of deoxymethasone.
Dose, Method and Time of Administration How to use Flubason: Posology
Flubason is initially applied 2-3 times a day in a thin layer on the affected skin region, rubbing lightly if possible. Subsequently, after clinical improvement, only one daily application may be sufficient.
Overdose What to do if you have taken too much Flubason
Systemic effects of glucocorticoids may occur when high amounts of deoxymethasone are absorbed, particularly after application of Flubason to large areas of skin or for prolonged periods.
In this case, the dose should be reduced or the treatment suspended. If suppression of the hypothalamic-pituitary-adrenal axis is suspected, treatment should be withdrawn gradually.
Side Effects What are the side effects of Flubason
In the treated skin area, folliculitis, hypertrichosis, acne, hyper or hypopigmentation, telangiectasias, striae, skin atrophy and maceration may occur. These topical effects occur particularly in the case of prolonged therapies and the use of occlusive dressings. In rare cases Flubason causes skin reactions of local hypersensitivity such as redness, edema, peeling and itching.
If used on large areas or for prolonged periods and if applied under occlusive dressings, there can be an absorption of quantities that are systemically active.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Special precautions for storage
This medicine does not require any special storage conditions.
To avoid the use of preservatives, which can give rise to sensitization phenomena, Flubason is prepared in a controlled bacterial environment. It is therefore recommended to use the single dose during the day.
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date shown on the package.
Keep this medicine out of the reach and sight of children.
Composition and pharmaceutical form
COMPOSITION
1 g of emulsion contains:
Active ingredient: deoxymethasone 2.5 mg.
Excipients: white petroleum jelly, isopropyl myristate, lanoceric alcohol, cetostearyl alcohol and purified water.
PHARMACEUTICAL FORM AND CONTENT
Water / oil skin emulsion.
15 single-dose sachets of 2 g each.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FLUBASON 0.25% SKIN EMULSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of emulsion contains:
active principle: deoxymethasone 2.5 mg.
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Water / oil skin emulsion
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Due to its high anti-inflammatory and anti-itching activity, Flubason is indicated in the treatment of the most important skin diseases of various kinds: allergic dermatitis such as contact dermatitis and eczema, psoriasis.
04.2 Posology and method of administration
Flubason should be applied initially 2-3 times a day, in a thin layer on the affected skin region, rubbing lightly if possible. Subsequently, after clinical improvement, only one daily application may be sufficient.
04.3 Contraindications
Known individual hypersensitivity to the active substance, to other corticosteroids or to any of the excipients. Local tuberculous or viral infections (e.g. herpes, chicken pox, etc.). Syphilis. Vaccinopathies. The Flubason is not for ophthalmic use.
Flubason's lotion contains paraffin which can cause latex condoms to leak or break. Therefore contact between Flubason and latex condom must be avoided.
Pregnancy. Feeding time. Occlusive therapy in subjects with atopic dermatitis.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. If this happens it is necessary to suspend the treatment and institute adequate therapy.
In the presence of skin infections it is necessary to institute suitable antibacterial and antifungal therapy and in case of its failure it is necessary to interrupt the corticosteroid treatment.
Flubason should be given to infants and small children only when clearly needed; this is due to the fact that the risk of systemic effects due to the absorption of glucocorticoids (eg growth retardation) is increased in this age group. In cases where treatment with Flubason is unavoidable, the application should be limited to the minimum dose compatible with therapeutic success and it is advisable to limit the use of the product to short periods of time.
In adults there may be exceptional circumstances in which the use of Flubason over large areas is unavoidable. In such cases the possibility of suppression of the hypothalamic-pituitary-adrenal axis must be considered, particularly with prolonged use. such suppression occurs, it may be necessary to gradually discontinue Flubason.
The topical application of corticosteroids in the treatment of extensive dermatoses and / or for prolonged periods can cause undesirable effects of systemic absorption such as arterial hypertension, asthenia, adynamia, heart rhythm disturbances, hypokalaemia and metabolic alkalosis.
When preparations containing corticosteroids, including Flubason, are repeatedly in contact with the conjunctival sac with topical application, an increase in intraocular pressure may develop over time. Therefore, repeated or prolonged application of Flubason in the immediate vicinity of the eyes it must be preceded by a "careful evaluation of the risk-benefit ratio and must only be carried out under medical supervision.
The medicine contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)
04.5 Interactions with other medicinal products and other forms of interaction
They are not known.
04.6 Pregnancy and lactation
The application of Flubason during pregnancy and lactation is contraindicated due to the risk of systemic absorption of deoxymethasone.
04.7 Effects on ability to drive and use machines
- ---
04.8 Undesirable effects
In the treated skin area, folliculitis, hypertrichosis, acne, hyper or hypopigmentation, telangiectasias, striae, skin atrophy and maceration may occur. These topical effects occur particularly in the case of prolonged therapies and the use of occlusive dressings.
In rare cases Flubason causes skin reactions of local hypersensitivity such as redness, edema, peeling and itching.
If used on large areas or for prolonged periods and if applied under occlusive dressings, there can be an absorption of quantities that are systemically active.
04.9 Overdose
Systemic effects of glucocorticoids may occur when high amounts of deoxymethasone are absorbed, particularly after application of Flubason to large areas of skin or for prolonged periods.
In this case, the dose should be reduced or the treatment suspended. If suppression of the hypothalamic-pituitary-adrenal axis is suspected, treatment should be withdrawn gradually.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: dermatological corticosteroids.
A.T.C code: D07AC03.
The deoxymethasone contained in Flubason is a highly active glucocorticoid specially developed for topical application. It has high anti-inflammatory, anti-allergic, anti-exudative, anti-proliferating and antipruritic activity.
Clinical efficacy
The antiproliferative effect of glucocorticoids is attributable to a reduced turnover rate of affected cells and a reduced rate of DNA synthesis. The consequences of this are well known and include inhibition of granulation, wound closure and fibroblastic proliferation.
The antiallergic effect of glucocorticoids derives from their immunosuppressive activity and from the effect on antibody- and cell-mediated hypersensitivity.
The immunosuppressive effect of glucocorticoids is mainly attributable to a reduction in the number and activity of lymphocytes (T-lymphocytes, B-lymphocytes).
Antibody-mediated hypersensitivity is also influenced by inhibition of vasoactive substances (eg histamine), while cell-mediated hypersensitivity is influenced by reduction of lymphokine release.
The anti-inflammatory effect is partly based on the interaction in the metabolism of arachidonic acid, associated with a reduced formation of inflammatory mediators, eg. prostaglandins and leukotrienes; moreover, excessive cellular signals are suppressed until they return to normal.
Systemic effects
To evaluate the systemic effects of the application of deoxymethasone on large areas, 25 g of Flubason were used applied on 50% of the body surface once a day for 7 days in 7 subjects.
Plasma concentrations and urinary excretion of 17-oxosteroids and 17-hydroxy-corticosteroids were evaluated before, during and after drug application. The expected reduction in plasma cortisol concentrations and the urinary excretion of 17-oxosteroids and 17-hydroxy-corticosteroids were detected during the application of Flubason. The value of these parameters increased again at the end of the treatment.
05.2 Pharmacokinetic properties
In patients with bromhidrosis, deoxymethasone, applied with an occlusive dressing, is absorbed to an evident extent already after 30 minutes; penetration is slower with loose dressing.
After an occlusive application for 48 hours, the drug is mainly detectable in the stratum corneum; the penetration quotient is increased in the case of psoriasis and eczema. However, 80% of the applied dose remains on the skin surface.
On intact skin after application of 8 g of marked product, with an occlusive bandage for 24 hours, there is a systemic absorption of 5%.
05.3 Preclinical safety data
The LD50 (mg / kg) of oral deoxymethasone is 1,495 ± 305 in rats.
Acute cutaneous and ocular application in rabbits does not give rise to phenomena of intolerance.
The results of the subacute and chronic toxicity tests, conducted from 30 days to 6 months in rats, rabbits and dogs with the use of different doses, show that in dogs, only after the application for 6 months of 400 mg / kg / day, haematological and organ alterations occur, however reversible 6 weeks after the end of treatment.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
White petroleum jelly, isopropyl myristate, lanoceric alcohol, cetostearyl alcohol and purified water.
06.2 Incompatibility
They are not known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Single-dose sachets; pack of 15 single-dose sachets of 2 g.
06.6 Instructions for use and handling
See 4.2.
07.0 MARKETING AUTHORIZATION HOLDER
sanofi-aventis S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
15 single-dose sachets: AIC n. 022864021
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
July 1973 / June 2010
10.0 DATE OF REVISION OF THE TEXT
March 2013