Active ingredients: Fluprednidene-21-acetate, Miconazole (Miconazole nitrate)
DECODERM 2% + 0.1% cream Tube of 20 g, 50 g, 100g
Why is Decoderm used? What is it for?
Decoderm contains two active ingredients:
- fluprednidene, which belongs to a class of medicines called 'glucocorticosteroids' used for inflammation,
- miconazole nitrate, which belongs to a class of medicines called 'antifungals' used against infections caused by fungi.
Decoderm is indicated for local (topical) use in the treatment:
- inflammatory skin diseases (inflammatory dermatomycoses) caused by dermatophytes (organisms that feed on dead skin cells), yeasts and / or fungi,
- inflammatory skin reactions (eczema) aggravated by fungal infections.
Decoderm is indicated only in the initial phase of treatment. After the symptoms of inflammation have disappeared, it is advisable to use only the medicine with antifungal (antifungal) action.
Contraindications When Decoderm should not be used
Do not use Decoderm
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from specific skin changes such as "tuberculosis" and "syphilis"
- if you suffer from infections caused by viruses (herpes simplex, shingles, chicken pox);
- if you have any reactions caused by vaccinations;
- if you suffer from skin changes (dermatitis) localized around the lips (periorals);
- if you suffer from a 'skin change called' rosacea ';
- if you have acne;
- if you have inflammation of the skin with pus formation (suppurative infections).
- for the eyes (ophthalmic use). Do not give Decoderm to very young children or infants, as the drug is contraindicated in this patient population
Do not apply Decoderm:
- on thinned areas of skin;
- on wounds;
- on skin lesions (ulcers);
- for extended periods of time;
- on large areas of the skin;
- under non-breathable (occlusive) dressings such as plasters etc., especially in children.
Precautions for use What you need to know before taking Decoderm
Talk to your doctor or pharmacist before using Decoderm.
- Avoid contact with mucous membranes.
- If you suffer from other diseases you should consider that anti-inflammatory medicines (corticosteroids) can alter the symptoms of some diseases, preventing a perfect diagnosis by the doctor.
- If you do have infections caused by resistant bacteria, your doctor will stop treatment and institute appropriate therapy.
- Take special care when applying Decoderm to the face, as the skin on the face is particularly sensitive and local side effects are more likely to occur. In particular, do not use Decoderm on the eyelids because serious side effects such as increased pressure in the eye (glaucoma) can develop.
- Decoderm contains petroleum jelly, so if you are using this medicine in the genital and anal areas, it may reduce the efficacy and safety of latex products (eg condoms, diaphragms).
In general, to avoid skin changes, long-term treatment with locally used inflammatory drugs called "corticosteroids" should be avoided.
Children
The medicine should be used in children only when clearly needed and under the direct supervision of the doctor. Decoderm is contraindicated in infants and young children.
Interactions Which drugs or foods can modify the effect of Decoderm
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
To date, there are no known interactions between other medicines and Decoderm.
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 on using this medicine.
There are no data on the use of Decoderm in pregnant and lactating women. Therefore, if you are pregnant or breastfeeding the use of the medicine is not recommended.
Driving and using machines
Decoderm does not affect the ability to drive or use machines.
Decoderm contains propylene glycol,
Propylene glycol can cause skin irritation.
Decoderm contains stearyl alcohol
Stearyl alcohol can cause local skin reactions (eg contact dermatitis).
Dose, Method and Time of Administration How to use Decoderm: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist
The recommended dose is:
a light layer of Decoderm to be applied on the affected part of the skin once or twice a day.
Do not use Decoderm for more than 7 days.
Overdose What to do if you have taken too much Decoderm
If you use more Decoderm than you should
If you accidentally ingest Decoderm do not be alarmed because the quantities of the two active ingredients are low. In case of accidental ingestion / intake of an overdose of Decoderm, notify your doctor immediately or go to the nearest hospital.
If you forget to use Decoderm
Do not use a double dose to make up for a forgotten dose.
If you stop taking Decoderm
If you stop taking Decoderm, you may have a relapse
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 Decoderm
Like all medicines, Decoderm can cause side effects, although not everybody gets them.
Side effects in the body (systemic) are rare.
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
- allergic reactions,
- irritation,
- red spots on the skin (rash),
- increased skin discoloration (hyperpigmentation),
- thinning (atrophy) of the skin,
- dilation of superficial blood vessels (telangiectasia),
- streaks on the skin (distension striae),
- acne induced by medicines used for inflammation (steroids),
- dermatitis around the mouth (perioral),
- increased hair (hypertrichosis),
- loss of skin color (depigmentation).
- alteration of the synthesis of some hormones (suppression of the hypothalamic-pituitary-adrenal axis). This effect can occur with the use of non-transpiring dressings (occlusive bandages) or when large areas of the body are treated with high doses and for prolonged periods ; children are more susceptible to such effects.
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
Do not store above 25 ° C.
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 refers to the product in intact packaging, correctly stored.
Validity after opening: 6 months
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 Decoderm
- The active ingredients are: - miconazole nitrate. 1 g of cream contains 20 mg of miconazole nitrate; - fluprednidene-21-acetate. 1 g of cream contains 1 mg of fluprednidene-21-acetate.
- The other ingredients are: purified water, propylene glycol, stearyl alcohol, Ariacel 165, glycerol monostearate 40-50%, white petroleum jelly, solid semisynthetic glycerides, dimethicone.
Description of the appearance of Decoderm and contents of the pack
Decoderm comes in the form of:
- Cream for external use in 20 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
DECODERM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains:
Active principles:
Miconazole nitrate 20 mg;
Fluprednidene 21-acetate 1 mg
Excipients:
Purified water, propylene glycol, stearyl alcohol (Ph.Eu.), glyceryl monostearate-macrogolstearate 5000 (1: 1), glycerol monostearate 40-55, medium chain triglycerides, white petroleum jelly, dimethicone 100.
03.0 PHARMACEUTICAL FORM
Cream
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Inflammatory dermatomycoses (caused by dermatophytes, yeasts and / or fungi). Eczema superinfected by fungi
DECODERM is indicated only in the initial phase of treatment. After the inflammatory symptoms have disappeared, it is advisable to use the antifungal alone.
04.2 Posology and method of administration
A light layer of DECODERM is applied to the affected part of the skin once or twice a day.
DECODERM therapy should not be continued for more than 7 days.
04.3 Contraindications
Hypersensitivity to one of the components.
DECODERM must not be used in the course of specific skin diseases (tuberculosis, syphilis), in the course of viral infections (herpes simplex, herpes zoster, chicken pox), in the presence of reactions to vaccinations, for the treatment of perioral dermatitis, rosacea, "acne, and in suppurative skin infections.
DECODERM is not for ophthalmic use, it must not be applied to thin skin, wounds and ulcers.
Avoid contact with mucous membranes.
Do not apply DECODERM for prolonged periods of time, on large skin areas and / or under occlusive bandages.
The preparation is also contraindicated in pregnancy and during lactation.
04.4 Special warnings and appropriate precautions for use
Relapses may occur when treatment is stopped.
Corticosteroid preparations can alter the clinical picture of some diseases thus preventing a perfect diagnosis.
The possibility of superinfections sustained by resistant microorganisms must be kept in mind, in which case it is advisable to suspend the use of the product and institute suitable therapy.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions in topical application.
04.6 Pregnancy and lactation
In pregnant and lactating women, the product is contraindicated (see Reproductive toxicity). In very early childhood and children in general, the product should only be used in case of real need and under the direct supervision of the doctor. .
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
Systemic side effects are rare; their appearance, however, can be favored by occlusive therapy or when large skin areas are treated with high doses and for prolonged periods of time.
Skin atrophy, telangiectasia, striae distensae, steroid acne, perioral dermatitis, hypertrichosis, depigmentation, and hormonal disorders may occur locally. In rare cases, allergic or irritative reactions or skin rash may occur.
04.9 Overdose
The use, especially if prolonged and excessive, can locally give rise to irritative phenomena, to skin atrophy and also to a suppressive effect on the adrenal cortex attributable to the increase in absorption.
While the irritation and adrenosuppressive effect disappear upon cessation of treatment, skin atrophy may persist.
The accidental ingestion of DECODERM is not alarming given that the percentages of the two active ingredients are low and that the effect of fluprednidene acetate disappears quickly.
It is therefore not necessary to take any specific measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacological profile
Fluprednidene acetate belongs to the class of strong glucocorticosteroids.
The antiallergic, antipruritic, antiproliferative and antiphlogistic activities of corticosteroids have been confirmed in numerous pharmacological experiments in both animals and humans.
The second active ingredient in the combination, miconazole nitrate, is an imidazole antifungal.
It has been clinically demonstrated that miconazole is active against dermatophils, Candida Spp, Pityrosporum Spp, Torulopsis glabrata, Aspergillus Spp, dimorphic fungi, Cryptococcus neoformans.
Miconazole is also active against gram-positive bacilli and cocci.
05.2 Pharmacokinetic properties
The pharmacokinetics of the combination were evaluated in experiments in female domestic pigs. After local application of DECODERM, 2.9-3.7% of fluprednidene acetate was recovered in the blood and urine for 24 hours, while miconazole was absorbed for 0.8%.
Cortisol levels were measured in humans to obtain information on the systemic absorption of fluprednidene acetate.
Since cortisol levels did not decrease and reactivity after stimulation with ACTH was not altered, a systemic effect of fluprednidene acetate can be excluded.
Bioavailability
After the topical application of the preparation, fluprednidene acetate rapidly penetrates the stratum corneum of the epidermis and accumulates in the skin barrier in a "delayed" form.
05.3 Preclinical safety data
Acute toxicity
The acute toxicity of fluprednidene acetate can be defined as low; in fact in the cutaneous application (rabbits, rats) a LD50 between 5000 -10000 mg / kg was determined.
A sensitizing effect of the preparation on the skin has not been demonstrated in animal experiments.
The acute lethal dose, after intraperitoneal and subcutaneous oral administration, is between 0.5 and 2.5 g / kg.
To define the local toxicity, after single administration of the DECODERM combination, the scarification test and the skin test were performed in man. No allergic reaction to the preparation was highlighted.
Chronic toxicity
In a 3-month study in pigs, fluprednidene acetate was applied topically in daily doses up to 0.5 g / kg; no local or systemic alterations attributable to the treatment were highlighted.
After repeated administration of miconazole, the target organ of the toxic effect has been shown to be the liver. However, this toxicity occurs only with oral doses above 30 mg / kg. It has been attributed to the activation of the enzymatic system for drug metabolism.
Topical administration of the cream combination for 13 weeks in pigs revealed no liver weight gain or other evidence of hepatotoxicity, although the daily administered dose of 0.5 g / kg corresponds to a daily dose of 35 g. of cream for an adult man weighing 70 kg.
Pharmacological studies in humans were conducted on healthy volunteers by performing scarification tests, administering cumulative doses for 10 days, skin test, atrophy test and a test in which the preparation was administered for 21 days. These studies also did not reveal allergic contact or irritative reactions; in the atrophy test the potential was not significantly higher than that of the base cream.
A determination of cortisol levels was performed (using ACTH) and this revealed that administration for 21 days (including 5 days of occlusive dressing) did not result in reduction of cortisol levels and that the stimulation with ACTH is the same both before. of the treatment that after 5 days and 21 days.
Carcinogenicity
There are no carcinogenicity studies in animals. No risk of carcinogenicity has ever been reported in the many years of use of these active substances in humans.
Mutagenicity
There was no evidence of mutagenic characteristics of fluprednidene acetate or miconazole.
Reproductive toxicity
The teratogenic properties of fluprednidene acetate were studied in rats and rabbits with epicutaneous doses up to 1000 mg / kg.
The following were highlighted: an increase in body weight and a slight increase in malformations. However, this was not considered as a strictly teratogenic effect but as the expression of the acute toxic effect of the preparation.
Hence the recommendation not to use dermatological agents containing fluprednidene in the first 3 months of pregnancy.
Miconazole nitrate has also been administered to rats and rabbits both in oral doses up to 100 mg / kg, and in the form of suppositories containing up to 12.5% miconazole.
Miconazole showed no teratogenic effects.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Purified water, propylene glycol, stearyl alcohol, Ariacel 165, glycerol monostearate 40-50%, white petroleum jelly, solid semisynthetic glycerides, dimethicone.
06.2 Incompatibility
They are not currently known.
06.3 Period of validity
The preparation can be kept for at least 3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
Validity after opening: 6 months
06.5 Nature of the immediate packaging and contents of the package
Box containing 20 g tube of cream
Box containing 50 g tube of cream
Box containing 100 g tube of cream
06.6 Instructions for use and handling
Dispose of in the appropriate containers.
07.0 MARKETING AUTHORIZATION HOLDER
Almirall Hermal GmbH
Scholtzstrasse, 3
21465 Reinbek - Germany
08.0 MARKETING AUTHORIZATION NUMBER
DECODERM 2% + 0.1% cream - 20 g tube A.I.C. n. 028407017
DECODERM 2% + 0.1% cream - 50 g tube A.I.C. n. 028407029
DECODERM 2% + 0.1% cream - 100 g tube A.I.C. n. 028407031
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
November 1994 / August 2004 / April 2009
10.0 DATE OF REVISION OF THE TEXT
May 2007
