Active ingredients: Betamethasone (betamethasone dipropionate), Salicylic acid
Diprosalic 0.05% + 3% ointment
Diprosalic package inserts are available for pack sizes:- Diprosalic 0.05% + 3% ointment
- Diprosalic 0.05% + 2% cutaneous solution
Why is Diprosalic used? What is it for?
Diprosalic contains betamethasone dipropionate and salicylic acid. Betamethasone belongs to a class of medicines called corticosteroids. Corticosteroids are hormones that perform nemerose activities, with an important function in controlling inflammation. Salicylic acid macerates the most superficial part of the skin (keratolytic activity), limits the growth of bacteria (bacteriostatic activity) and kills fungi (fungicidal activity) in the skin.
Diprosalic ointment is indicated in the treatment of the following skin diseases:
- chronic eczema, characterized by scaly, thickened skin with hard-to-heal cuts;
- neurodermatitis, characterized by itching and peeling;
- itchy, warty psoriasis, characterized by white, thickened scaling with red, itchy patches.
Contraindications When Diprosalic should not be used
Do not use Diprosalic
- if you are allergic to betamethasone, other corticosteroids or salicylic acid, other salicylates or any of the other ingredients of this medicine (listed in section 6);
- if you have vaccine pustules, which are characterized by pus-containing patches of the skin of various sizes;
- if you have infectious diseases such as chickenpox, Herpes simplex and tuberculosis of the skin.
Precautions for use What you need to know before taking Diprosalic
Talk to your doctor or pharmacist before using Diprosalic.
Do not put Diprosalic in contact with the eyes and mucous membranes (mouth or genitals). If you use Diprosalic in the presence of skin infections, your doctor will prescribe adequate treatment against bacteria or fungi. Your doctor will stop treatment with Diprosalic if it does not work.
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.
Do not use with occlusive dressing (non-breathable, for example made of polyethylene).
The use, especially if prolonged, of products applied to the skin can cause allergy phenomena. In this case the doctor will suspend the treatment and prescribe a suitable therapy.
Your doctor will take special care if you use Diprosalic on large areas of skin or if you apply it under an occlusive dressing (non-breathable, for example made of polyethylene) or when it is intended for long-term use, particularly in infants and children.
If during treatment you notice that your skin becomes excessively dry or further irritated, stop taking Diprosalic.
Children
More harmful effects may occur if you use Diprosalic in a child than in adults. Corticosteroids used locally in children can affect some hormones (suppression of the adrenal-hypothalamus-pituitary axis and Cushing's syndrome), cause growth retardation, weight gain and cause an increase in pressure inside the skull (intracranial hypertension ) characterized by fontanel swelling and severe headache Manifestations of adrenal suppression in children include low plasma cortisol levels and lack of response to ACTH stimulation.
Interactions Which drugs or foods can modify the effect of Diprosalic
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Betamethasone dipropionate and salicylic acid, administered on the skin at the recommended doses, do not interact significantly with other medicines.
However, if you have to apply Diprosalic to large areas of the skin or for long periods it may have interactions with other medicines.
The effectiveness of betamethasone is reduced by:
- barbiturates (medicines used mainly to treat anxiety and to induce sleep);
- antihistamines (medicines used to treat allergies);
- diphenylhydantoin (medicine used to treat epilepsy).
The efficacy of betamethasone is increased by:
- salicylates and phenylbutazone (medicines used to treat inflammation).
Betamethasone reduces the effect of:
- oral hypoglycaemics and insulin (medicines used to treat diabetes).
Salicylic acid increases the effect of:
- oral antidiabetic agents;
- sulphonamides (medicines used to treat bacterial infections);
- methotrexate (medicine used to treat some types of cancer and diseases of the body's defense system);
- probenecid (medicine used to treat gout).
In addition, an "interaction of salicylic acid with heparin (a medicine used to thin the blood) and with naproxen (a medicine used to treat inflammation and fever) has also been reported. In the first case there was an induction of bleeding, in the second case an increase in the elimination of the drug by the kidneys.
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 only use Diprosalic if your doctor believes that the potential benefit to you justifies the possible risk to the fetus. Do not use Diprosalic on large areas of the body, in large quantities or for prolonged periods of time.
Feeding time
It is not known whether the medicine passes into breast milk. Your doctor will decide whether to discontinue breast-feeding or to discontinue treatment with Diprosalic, taking into account how important your therapy with this medicine is. As with any other medicine similar to this, if you are pregnant or breast-feeding. breast, your doctor will prescribe Diprosalic in cases of real need, and will monitor you.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Diprosalic: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Apply Diprosalic ointment 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 Diprosalic
If you use more Diprosalic than you should
Avoid excessive and prolonged use of Diprosalic on large areas of the skin, as it can lead to improper functioning of the adrenal glands (manifestations due to over-functioning of the adrenal glands, including Cushing's syndrome) and may experience symptoms of excess salicylic acid (increased breathing, liver damage, nausea, vomiting, heartburn, ringing in the ears, excessive sleep and confusion). In this case your doctor will advise you to stop treatment, reduce the frequency of applications or replace Diprosalic with another medicine.
If you forget to use Diprosalic
Do not use a double dose to make up for a forgotten dose.
If you stop taking Diprosalic
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 Diprosalic
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Whole body (systemic) side effects are very rare; however, their occurrence may be favored when applying the medicine to large areas of the skin, with high doses and for prolonged periods of time, especially if you use the medicine. in infants and children.
In the treatment area, the following can occur:
- sense of burning;
- irritation;
- dry skin;
- infection involving the upper part of the hair follicle (folliculitis);
- appearance of acne;
- increased hair (hypertrichosis);
- discolouration of the skin (hypopigmentation);
- thinning of the skin (skin atrophy);
- inflammation with red rashes around the mouth (perioral dermatitis);
- allergic skin reaction due to contact (allergic contact dermatitis);
- inflammation of the skin (dermatitis).
The following effects may be more frequent with the use of occlusive dressing:
- maceration of the skin;
- infection;
- thinning of the skin (skin atrophy);
- skin streaks;
- itchy rash with sweat retention (miliaria).
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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
After first opening, Diprosalic ointment is valid for three 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.
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.
Composition and pharmaceutical form
What Diprosalic contains
- The active ingredients are betamethasone dipropionate and salicylic acid. 100 g of ointment contains 0.064 g betamethasone dipropionate and 3 g salicylic acid;
- The other ingredients are: liquid paraffin and white petroleum jelly.
Description of what Diprosalic looks like and contents of the pack
Diprosalic ointment, 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
DIPROSALIC
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of ointment contains:
Betamethasone dipropionate 0.064 g
Salicylic acid 3 g
100 g of cutaneous solution contain:
Betamethasone dipropionate 0.064 g
Salicylic acid 2 g
03.0 PHARMACEUTICAL FORM
Ointment and cutaneous solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Diprosalic ointment is indicated in chronic eczema, neurodermatitis, warty and itchy psoriasis.
Diprosalic cutaneous solution is indicated in psoriasis and seborrheic dermatitis of the scalp and areas covered with hair.
04.2 Posology and method of administration
Apply Diprosalic ointment or skin solution in sufficient quantity to cover the entire affected area and massage gently until completely absorbed.
The high activity and the long-lasting action allow to obtain the desired results with 2 applications per day. With the cutaneous solution it is sometimes possible to obtain an adequate maintenance therapy with only 1 application per day.
04.3 Contraindications
Vaccine pustules, chicken pox, herpes simplex and cutaneous tuberculosis. Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
If the preparation is administered in the presence of skin infections, institute adequate antibacterial or antifungal therapy and, if unsuccessful, discontinue corticosteroid treatment.
Any of the side effects reported with systemic corticosteroid treatment, including adrenal suppression, may also occur with topical treatment, especially in infants and children.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. If this happens, treatment must be suspended and appropriate therapy instituted.
Systemic absorption of topical corticosteroids or salicylic acid is increased if large areas of skin are treated or if occlusive dressing is used. In these conditions, or when long-term use is anticipated, particularly in infants and children , due precautions must be taken.
If during treatment with Diprosalic cutaneous solution and Diprosalic ointment the skin becomes excessively dry or further irritated, discontinue therapy.
The preparation cannot be used for ophthalmic use. Avoid contact with eyes and mucous membranes.
Do not use in occlusive dressings.
Pediatric use: children may demonstrate greater sensitivity to adrenal-hypothalamus-pituitary axis suppression induced by topical corticosteroids and to the effects of exogenous corticosteroids compared to mature patients due to greater absorption due to a higher ratio of the area of the skin surface and weight.
Suppression of the adrenal-hypothalamic-pituitary axis, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children treated with topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and lack of response to ACTH stimulation. Manifestations of intracranial hypertension include swelling of the fontanelles, headaches and edema of the optic nerve papilla.
04.5 Interactions with other medicinal products and other forms of interaction
Betamethasone dipropionate and salicylic acid administered topically at the recommended dosages do not give rise to drug interactions of clinical relevance. However, for applications on large skin areas or for long periods, signs of systemic activity may occur and therefore also phenomena of medicinal interactions with other drugs.
For the corticosteroid they are expressed through three mechanisms: enzymatic 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.
For salicylic acid, interactions with oral antidiabetic agents, sulfonamides, methotrexate and probenecid of which it increases the pharmacological activity by binding competition are to be reported.
Interaction has also been reported with heparin and naproxen: in the first case it was found induction of bleeding, in the second increased renal excretion.
04.6 Pregnancy and lactation
Since the safety of topical corticosteroids in pregnant women has not been proven, drugs of this class should only be used during pregnancy if the potential benefit justifies the possible risk to the fetus. Drugs of this class should not be used in pregnant women extensively in large quantities or for prolonged periods of time.
Since it is not known whether topical administration of corticosteroids may result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision must be made whether to discontinue breast-feeding or to terminate therapy, taking into account the importance of the drug for the mother.
Like any other corticosteroid, in women during pregnancy or breastfeeding the product should be administered in cases of real need, under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Diprosalic does not alter the state of mental alertness.
04.8 Undesirable effects
Topical systemic side effects of corticosteroids are very rare; their appearance, however, can be favored when large skin areas are treated with high doses and for prolonged periods of time, especially in infants and children. Sometimes there may be a burning sensation, irritation, dry skin, folliculitis, acne eruptions, hypertrichosis, hypopigmentation, skin atrophy, perioral dermatitis and allergic contact dermatitis. The following effects may be more frequent with the use of occlusive dressing: skin maceration, secondary infection, skin atrophy, striae and miliaria.
Preparations based on salicylic acid can cause dermatitis.
04.9 Overdose
Excessively prolonged use of topical corticosteroids over large areas of the skin can suppress pituitary-adrenal function, leading to adrenal insufficiency and produce overt hypercorticism, including Cushing's syndrome. Excessive or prolonged use of topical salicylic acid preparations can lead to symptoms of salicism.
Appropriate symptomatic treatment is indicated. Symptoms of hypercorticalism spontaneously subside; it is advisable not to stop therapy suddenly and, if necessary, to treat the electrolyte imbalance. In case of chronic toxicity, it is advisable to stop the treatment progressively.
In salicilism the treatment is symptomatic; rapidly eliminate salicylate from the patient by administering sodium bicarbonate by mouth.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, dermatological preparations, other combinations; ATC code: D07XC01.
Diprosalic is a preparation for dermatological use based on betamethasone dipropionate (9alpha-fluoro-16beta-methylprednisolone-17,21 dipropionate) and salicylic acid.
Diprosalic ointment: the components are dispersed in a hypoallergenic vehicle, free of parabens, based on petroleum jelly and liquid paraffin designed to provide maximum therapeutic efficacy in dry forms where it is necessary to exert a deep and emollient action.
Diprosalic cutaneous solution: it is particularly suitable for the treatment of dermatoses of the scalp and other areas covered by hair.
The components are dissolved in a hydroalcoholic, non-sensitizing, pleasant, fat-free, paraben-free vehicle. Betamethasone dipropionate is a synthetic corticosteroid with a prompt and prolonged anti-inflammatory activity, able to act both on epidermal phenomena (vesiculation, pustulation, exudation) and on those affecting the dermis (edema, infiltration), as well as on subjective symptoms (itching and burning).
Salicylic acid (ortho-hydroxybenzoic acid) at 3% exerts a keratolytic action, that is to loosen the bonds that hold together the cells of the stratum corneum of the hyperkeratotic skin, which manifests itself with the detachment of scales, crusts and scaly-crusts present in many seborrheic, dysplastic-hyperkeratotic and inflammatory conditions.
Salicylic acid also has a bacteriostatic effect against gram-positive and gram-negative germs and a fungicidal effect on Dermatophiles, Aspergillus and Candida sp.
05.2 Pharmacokinetic properties
Betamethasone dipropionate, especially when applied to large body surfaces or with the occlusive dressing technique, is absorbed epicutaneously and can produce systemic effects.
The main seat of the metabolic processes of betamethasone dipropionate is the liver, where it is inactivated. In fact, it undergoes conjugation with sulphate or glucuronic acid in the liver and kidney and as such is excreted in the urine.
Salicylic acid is rapidly absorbed by intact skin especially if it is dispersed in oily vehicles or ointments.
It undergoes metabolic processes by different tissues, but especially the liver, where it is transformed into salicyl-uric acid and in part is also glucuronate. The main route of excretion is the renal one where it is found unchanged for 10%, for 75% as salicyl-uric acid and for 10% as salicylphenolglicuronide.
05.3 Preclinical safety data
Acute toxicity tests were conducted orally in rats with doses up to 20 g / kg, by epicutaneous (intact or abraded skin) in rats and rabbits up to 3.3 g / kg. All the animals tolerated the administered doses perfectly. Chronic toxicity tests conducted on rats and rabbits via epicutaneous route with doses up to 333 mg / kg / day for 60 consecutive days, did not show any toxic effect of the product.
Betamethasone dipropionate and salicylic acid have no structural affinity with substances with an established carcinogenetic and mutagenic action.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ointment: Liquid paraffin, white petroleum jelly.
Skin solution: Edetate sodium, hypromellose, sodium hydroxide, isopropyl alcohol, purified water.
06.2 Incompatibility
To date, no incompatibility with other drugs is known.
06.3 Period of validity
With intact packaging:
Diprosalic ointment: 3 years;
after first opening: 3 months.
Diprosalic cutaneous solution: 18 months; after first opening: 6 weeks.
06.4 Special precautions for storage
Skin solution:
Do not store above 25 ° C.
Keep out of sight.
Protect from light.
Flammable.
06.5 Nature of the immediate packaging and contents of the package
Diprosalic ointment: tube of 30 g
Diprosalic cutaneous solution: bottle of 30 g
06.6 Instructions for use and handling
None in particular.
07.0 MARKETING AUTHORIZATION HOLDER
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
Sales dealer
ESSEX ITALIA S.r.l.
Via Fratelli Cervi, snc
Milan Due Business Center
Palazzo Borromini
20090 Segrate (MI)
08.0 MARKETING AUTHORIZATION NUMBER
Diprosalic ointment: AIC 023839018
Diprosalic cutaneous solution: AIC 023839020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Diprosalic ointment 12 July 1979 / June 2010
Diprosalic cutaneous solution February 18, 1983 / June 2010
10.0 DATE OF REVISION OF THE TEXT
September 2012.
