Active ingredients: Betamethasone (betamethasone dipropionate)
Diprosone 0.05% cream
Diprosone package inserts are available for pack sizes:- Diprosone 0.05% cream
- Diprosone 0.05% ointment
- Diprosone 0.05% cutaneous solution
Why is Diprosone used? What is it for?
Diprosone contains the active substance betamethasone dipropionate, which belongs to a class of medicines called corticosteroids.
Corticosteroids are hormones that perform numerous activities, with an important function in controlling inflammation.
Diprosone is indicated in the treatment of the following skin diseases (dermatoses):
- Contact eczema, characterized by redness, peeling, small blisters, bubbles, small superficial wounds and caused by contact with certain substances such as detergents, cosmetics or substances used for work;
- Constitutional eczema, characterized by redness and blistering, often accompanied by severe itching;
- Seborrheic eczema of adults and infants (cradle cap), characterized by yellowish and greasy scales, redness, small scabs and sometimes itching affecting the scalp, face, ears and chest;
- Stasis eczema, characterized by darker areas of the skin, with red, thin, sometimes thickened spots, with the presence of itching and pain;
- Dyshidrosis, characterized by small, often itchy blisters that contain a clear liquid
- Generalized and anogenital itching;
- Intertrigo, characterized by redness, peeling, irritation and itching due to the rubbing of two neighboring parts of the body;
- Solar erythema, characterized by itching, pain, burning sensation and the presence of blisters;
- Irritative forms caused by plants, chemicals, insect bites;
- Psoriasis, characterized by red patches, thickening, silvery-white flaking and sometimes itching
- Other inflammatory skin diseases such as VidalBrocq's lichen simplex characterized by severe itching and thickening of the skin and lichen ruber planus characterized by itchy dark red skin reliefs with a rounded or polygonal shape;
- Dermatosis in which bacteria are also present. In this case, Diprosone must be associated with a specific antibiotic.
Contraindications When Diprosone should not be used
Do not use Diprosone
- if you are allergic to betamethasone dipropionate, other corticosteroids or any of the other ingredients of this medicine
- if you have cutaneous tuberculosis, a form of tuberculosis that affects the skin;
- if you have viral diseases located in the skin (herpes simplex, smallpox, chicken pox).
If you have atopic dermatitis, characterized by itching, redness, peeling and raised skin, do not use an occlusive (non-breathable, e.g. polyethylene) dressing with Diprosone.
Precautions for use What you need to know before taking Diprosone
Talk to your doctor or pharmacist before using Diprosone.
Do not put Diprosone in your eyes.
The doctor will pay particular attention in cases where Diprosone is used for long periods, on a large surface of the skin and especially if it is applied under an occlusive dressing (not breathable, eg polyethylene). This is because the medicine in these cases it can pass into the blood and can affect some hormones, blood sugar and urine sugar levels, and decreased urine excretion of certain hormones (17-KS and 17-OHCS).
If you develop irritation following the application of the medicine, stop the treatment and inform your doctor immediately who will prescribe an appropriate therapy.
If you develop a skin infection while using Diprosone, consult your doctor who will recommend suitable treatment. If the treatment is not effective, the doctor will stop the treatment with Diprosone, until the infection is resolved.
The use, especially if prolonged, of medicines applied to the skin can cause allergy phenomena. In this case the doctor will stop the treatment and prescribe a suitable therapy.
As with all high activity cortisone preparations for local use, the doctor will stop treatment with Diprosone as soon as the disease is under control.
Any maintenance therapy will be carried out with Diprosone cream or alternating Diprosone ointment with Diprosone cream.
Given the characteristics of Diprosone cream, application with an occlusive bandage is not recommended.
All side effects that are reported after systemic use of corticosteroids (eg administered by mouth) may also occur with corticosteroids applied topically to the skin (topical use), especially in infants and children.
Children and adolescents
In very early childhood, the drug should be administered in cases of real need.
All undesirable effects, including influence on some hormones, can occur especially in infants and children, including growth retardation affecting both height and body weight. In newborns, the diaper can act as an occlusive dressing.
Interactions Which drugs or foods can modify the effect of Diprosone
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
The effectiveness of Diprosone is reduced by:
- barbiturates (medicines used mainly to treat anxiety and to induce sleep);
- antihistamines (medicines used to treat allergies);
- diphenylhydantoin (medicines used to treat epilepsy).
The effectiveness of Diprosone is increased by:
- salicylates and phenylbutazone (medicines used to treat inflammation).
Diprosone reduces the effectiveness of:
- oral hypoglycaemics and insulin (medicines used to treat diabetes).
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy:
If you are pregnant, use this medicine only when clearly needed and under the direct supervision of your doctor.
Feeding time:
It is not known whether the medicine passes into breast milk. Your doctor will decide whether to stop Diprosone, taking into account how important your treatment with this medicine is to you.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Diprosone cream contains:
- cetostearyl alcohol which can cause skin reactions (e.g. contact skin inflammation);
- chlorocresol which can cause allergic reactions.
Dose, Method and Time of Administration How to use Diprosone: Posology
Always use this medicine exactly as your doctor or pharmacist has told you.
If in doubt, consult your doctor or pharmacist. Apply Diprosone cream 1-2 times a day.
Spread a sufficient amount to cover the entire affected area and massage gently until completely absorbed.
Overdose What to do if you have taken too much Diprosone
In case of accidental ingestion / application of an overdose of Diprosone, notify your doctor immediately or go to the nearest hospital.
Avoid excessive and prolonged use of Diprosone, as it can cause malfunction of the adrenal glands, which is usually reversible. In this case, your doctor will advise you to stop treatment, reduce the frequency of applications or replace Diprosone with another medicine.
If you forget to use Diprosone
Do not use a double dose to make up for a forgotten dose.
If you stop taking Diprosone
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Diprosone
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During cortisone therapy on the skin, especially for intense and prolonged treatments, some of the following side effects may occur:
- burning sensation;
- itch;
- irritation;
- dry skin;
- thinning of the skin (skin atrophy);
- acne;
- discolouration of the skin (hypopigmentation);
- inflammation with red rashes around the mouth (perioral dermatitis);
- skin reaction due to contact (contact dermatitis);
- maceration of the skin;
- infection with fungi, bacteria and viruses;
- atrophy, itchy rash with sweat retention (miliaria) and localized streaks in the rubbing areas treated for long periods of time with an occlusive bandage.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety. of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
After first opening, Diprosone cream is valid for 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP."
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Diprosone contains
- The active ingredient per 100 g of cream is betamethasone 17.21-dipropionate 0.064 g equal to betamethasone alcohol 0.05 g.
- The other ingredients are: chlorocresol, monobasic sodium phosphate dihydrate, phosphoric acid, white petroleum jelly, liquid paraffin, polyethylene glycol monocethyl ether (Cetomacrogol 1000), cetostearyl alcohol, purified water.
What Diprosone looks like and contents of the pack
Diprosone cream 0.05% - 30 g tube.
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
DIPROSONE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
active ingredient: betamethasone 17.21 dipropionate 0.064g (equal to alcohol betamethasone 0.05 g).
100 g of ointment contains:
active ingredient: betamethasone 17.21 dipropionate 0.064 g (equal to alcohol betamethasone 0.05 g).
100 g of cutaneous solution contain:
active ingredient: betamethasone 17.21 dipropionate 0.064 g (equal to alcohol betamethasone 0.05 g).
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream, ointment, skin solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cream
Dermatosis sensitive to corticosteroids and in particular the forms localized in the sites with thinner and more delicate skin:
• Contact eczema (from detergents, cosmetics or of a professional nature)
• Constitutional eczema
• Seborrheic eczema of adults and infants (cradle cap)
• Stasis eczema
• Dyshidrosis
• Generalized and anogenital itching
• Intertriges
• Sunburn
• Primary irritative forms (from vegetables, from chemicals, from insect bites).
Further indications of the preparation are psoriasis and other deep inflammatory dermatoses such as Vidal-Brocq's lichen simplex and lichen ruber planus.
Ointment
Dermatosis sensitive to corticosteroids and in particular the dry and hyperkeratotic forms.
• Psoriasis
• Lichenified eczemas
• Lichen ruber planus
• Contact eczema (from detergents, cosmetics, or of a professional nature) in the desquamation phase
• Constitutional eczema
• Stasis eczema
• Dyshidrosis
• Anogenital itching
• Sunburn
• Primary irritative forms (from vegetables, from chemicals, from insect bites).
Skin solution
• Dermatosis of the scalp (seborrheic and microbial eczema, dry or oily pityriasis, psoriasis)
• Erythematous-exudative manifestations of intertriginoid folds or localized in areas covered with hair
• Other dermatoses sensitive to cortisones.
In dermatoses where a microbial or fungal component is present, a specific chemo-antibiotic should be associated with Diprosone. If unsuccessful, discontinue corticosteroid treatment.
04.2 Posology and method of administration
Apply Diprosone cream, ointment or skin solution, 1-2 times a day in sufficient quantity to cover the affected area and massage gently until completely absorbed.
04.3 Contraindications
Topical cortisones are contraindicated in subjects with hypersensitivity to the active ingredient or to any of the excipients, in patients with cutaneous tuberculosis and herpes simplex as well as with viral diseases with skin localization (smallpox, chicken pox). Occlusive therapy is contraindicated in subjects with atopic dermatitis.
04.4 Special warnings and appropriate precautions for use
General: Systemic absorption of topical corticosteroids may produce reversible suppression of the adrenal-hypothalamus-pituitary (HPA) axis, with the possibility of glucocorticosteroid insufficiency after discontinuation of treatment. In some patients, manifestations of Cushing's syndrome may also occur following systemic absorption of corticosteroids during treatment. Patients receiving high amounts of particularly active topical steroids applied to large skin areas should be evaluated periodically in order to detect the suppression of the adrenal-hypothalamus-pituitary axis. If suppression of the adrenal-hypothalamic-pituitary axis occurs, an attempt should be made to discontinue the drug, reduce the frequency of applications or replace it with another less potent corticosteroid.
Restoration of HPA axis function is usually rapid and complete once the drug is discontinued. Deprivation symptoms may sometimes occur, requiring supplemental systemic corticosteroids.
All undesirable effects that are reported following systemic corticosteroid use, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
If irritation occurs, treatment should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, a suitable antifungal and antibacterial medicine must be used. If there is no prompt favorable response, the corticosteroid should be withheld until the infection has been adequately controlled.
The epicutaneous application of cortisone in the treatment of extended dermatoses and for prolonged periods can cause systemic absorption; this occurrence occurs more easily when the occlusive bandage is used.
In infants, the diaper can act as an occlusive dressing.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, suspend the treatment and institute a suitable therapy.
As with all high-activity cortisone preparations for topical use, treatment should be stopped as soon as the dermopathy has been controlled.
Any maintenance therapy will be advantageously carried out with Diprosone cream, or alternating Diprosone ointment with Diprosone cream.
The preparation cannot be used for ophthalmic use. Given the physico-chemical characteristics of the preparation it is not required and it is not recommended to apply it with an occlusive bandage.
Use in pediatrics: pediatric patients may prove more sensitive than adults to depression of the adrenal-hypothalamus-pituitary axis induced by topical cortisone and to the effects of exogenous corticosteroids, given the greater absorption due to the high ratio of skin surface to body weight.
Depression of the adrenal-hypothalamic-pituitary axis, Cushing's syndrome and intracranial hypertension have been described in children treated with topical corticosteroids. with ACTH Manifestations of intracranial hypertension include tension of the fontanelles, headache, and bilateral papilledema.
Diprosone cream contains, among the excipients, cetostearyl alcohol and chlorocresol: the former can cause local skin reactions (for example contact dermatitis) while the latter can cause allergic reactions.
04.5 Interactions with other medicinal products and other forms of interaction
Local administration of betamethasone dipropionate, especially for applications on large skin areas or for long periods, can cause phenomena of systemic activity such as glycosuria and postprandial hyperglycemia; moreover, in occlusion it can induce a decrease in urinary excretion of 17-KS and 17-OHCS.
Phenomena of drug interaction with other drugs may also occur, mainly through 3 mechanisms: enzyme induction, displacement, opposite activity.
Barbiturates, antihistamines and diphenylhydantoin, by inducing an increase in the metabolization of the steroid, reduce its pharmacological activity.
Anti-inflammatories, such as salicylates and phenylbutazone, by displacing the steroid from its binding to plasma proteins, increase its activity.
Oral hypoglycemic agents and insulin are counteracted in their action by the increase in glycaemia induced by the steroid due to its intense glyconeogenetic and glycogenolytic activity.
04.6 Pregnancy and lactation
Pregnancy: there are no adequate and well-controlled studies in pregnant women of the teratogenic potential of locally applied corticosteroids. Therefore, in women during pregnancy or breastfeeding and in very early childhood, the product should be administered in cases of real need and under the direct supervision of the doctor.
Feeding time: it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce measurable concentrations in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities that are unlikely to harm the infant. However, a decision must be made whether to discontinue the medicine, taking into account the importance of the medicine to the mother.
04.7 Effects on ability to drive and use machines
Diprosone does not affect the ability to drive or use machines.
04.8 Undesirable effects
During epicutaneous cortisone therapy, especially for intense and prolonged treatments, some of the following side effects may occur: burning sensation, itching, irritation, dry skin, skin atrophy, acne rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, atrophy, miliary and striae localized to the intertriginous areas treated for long periods of time, especially if with occlusive dressing.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous 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. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Excessively prolonged use of topical corticosteroids can depress the pituitary-adrenal axis (HPE), causing secondary adrenal insufficiency. If suppression of the HPE axis occurs, attempts should be made to discontinue the drug, reduce its frequency of applications, or replace it with another less potent corticosteroid. Hypercorticoid symptoms are effectively reversible spontaneously. Treatment is symptomatic. If necessary, symptoms of hypercorticoidism are spontaneously reversible. rebalance the hydro-electrolyte balance.
In case of chronic toxicity, slowly remove the corticosteroid from the body.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: corticosteroids, dermatological preparations.
ATC code: D07AC01.
Betamethasone dipropionate is a corticosteroid with particularly strong anti-inflammatory, anti-allergic and anti-itching activity, also characterized by good tolerability.
In the cream, the active ingredient is dispersed in a creamy, hypoallergenic, emollient, pleasant, moisturizing, non-greasy, white vehicle that can be removed with water and is particularly suitable for promoting the activity of betamethasone dipropionate.
In the ointment, betamethasone dipropionate is dispersed in a hypoallergenic vehicle, based on white vaseline and petroleum jelly studied in order to provide maximum therapeutic efficacy in dry forms where it is necessary to exert an emollient action.
In the cutaneous solution, specifically designed for the treatment of dermatoses of the scalp and other areas covered with hair, betamethasone dipropionate is dissolved in a hydroalcoholic, non-sensitizing, pleasant, fat-free and paraben-free vehicle, whose viscosity has been studied so that the skin solution is not too fluid and at the same time can be easily distributed without sticking to the hair. The preparation brings a pleasant fresh sensation, without leaving odors or residues and can be easily removed with water.
05.2 Pharmacokinetic properties
Betamethasone dipropionate, especially if applied on large body surfaces and / or with the occlusive bandage technique and / or for a long time, can be absorbed by the epicutaneous route and produce systemic effects.
The main seat of the metabolic processes of betamethasone dipropionate is the liver, where it is inactivated. In the liver and kidney it is conjugated with sulfuric acid or glucuronic acid and as such excreted in the urine.
05.3 Preclinical safety data
The preparations of Diprosone, administered to Wistar rats with gastric tube, did not cause the death of any animal even at the maximum administrable dose of 20 ml of product per kg of body weight.
An application on shaved rat skin of the various Diprosone preparations at a dose of 2 g / kg / day (10 times higher than the maximum usable for humans), for 6 weeks did not cause any local negative effects, but only modest effects of general character referable to the very small amount of betamethasone dipropionate absorbed and entered into the circulation.
Diprosone cutaneous solution, administered by epicutaneous route, did not cause death or any apparent disturbance in rats, rabbits and pigs even at a single dose approximately 100 times higher than the average per kg / day recommended in humans.
In acute and chronic toxicity studies or in clinical trials, betamethasone dipropionate has never shown phenomena capable of suggesting carcinogenic or mutagenic potential.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cream
Chlorocresol, monobasic sodium phosphate dihydrate, phosphoric acid, white petroleum jelly, liquid paraffin, polyethylene glycol monocethyl ether (Cetomacrogol 1000), cetostearyl alcohol, purified water.
Ointment
Liquid paraffin, white petroleum jelly.
Skin solution
Carboxypolymethylene, isopropyl alcohol, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
With intact packaging:
Cream: 3 years.
Ointment: 3 years.
Skin solution: 2 years.
After first opening:
Cream: 3 months.
Ointment: 3 months.
Skin solution: 3 months.
06.4 Special precautions for storage
Cream and ointment: this medicine does not require any special storage conditions.
Skin solution: keep away from eyes. Keep the bottle in the outer carton to protect from light. Medicinal product containing flammable substance.
06.5 Nature of the immediate packaging and contents of the package
Cream: tube of 30 g.
Ointment: tube of 30 g.
Skin solution: bottle of 30 g.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
Sales dealership
Essex Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
08.0 MARKETING AUTHORIZATION NUMBER
Diprosone 0.05% cream: tube of 30 g AIC 023087024
Diprosone 0.05% ointment: tube of 30 g AIC 023087051
Diprosone 0.05% cutaneous solution: bottle of 30 g AIC 023087075
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization:
Diprosone cream and ointment: 23/01/1975
Diprosone cutaneous solution: 09/21/1979
Date of most recent renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
April 2015
