Active ingredients: Triamcinolone benetonide, Fusidic acid
DERMOMYCIN CORT 0.03% + 2% CREAM
Why is Dermomycin Cort used? What is it for?
Pharmacotherapeutic group
DERMOMYCIN CORT results from the association of a steroid (TBI) expressly studied for local use and an antibiotic (fusidic acid) particularly active in bacterial skin infections.
Indications
Therapy of bacterial pyoderma characterized by an exaggerated inflammatory component, in order to simultaneously combat the causative agent and hyperreactivity. Prevention and therapy of secondary impetiginization of all primitively uninfected allergic and dysreactive dermatoses.
Contraindications When Dermomycin Cort should not be used
Known hypersensitivity to any component of the product.
Corticosteroid preparations are contraindicated in subjects suffering from cutaneous TB and Herpes simplex, as well as from viral and fungal diseases with skin localization.
Precautions for use What you need to know before taking Dermomycin Cort
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 newborns, the diaper can act as an occlusive bandage. In the presence of superinfection. skin, appropriate coverage therapy should be instituted.
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena.
Avoid ophthalmic use and application in the external ear canal in case of tympanic perforation.
Interactions Which drugs or foods can modify the effect of Dermomycin Cort
Do not report.
Warnings It is important to know that:
In pregnant women and in very early childhood, the product should be administered in cases of real need, under the direct supervision of the doctor.
Dose, Method and Time of Administration How to use Dermomycin Cort: Posology
Clean the affected skin area, then apply a layer of cream 2-3 mm high and rub lightly. The operation should be repeated initially 3 times a day, then 2 times, once in the morning and once in the evening.
Overdose What to do if you have taken an overdose of Dermomycin Cort
There are no known effects to be attributed to overdose of Dermomycin Cort
Side Effects What are the side effects of Dermomycin Cort
During epicutaneous cortisone therapy, especially for intense and prolonged treatments, some of the following side effects may occur: burning sensations, itching, irritation, dry skin, skin atrophy, acne rash, hypopigmentation, atrophy and striae localized to the intertriginous areas treated for a long period of time with occlusive dressing.
The possible occurrence of secondary effects related to the use of the product must be reported to the treating physician or pharmacist.
Expiry and Retention
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN
Warning: do not use the product after the expiry date indicated on the package
Composition and pharmaceutical form
Composition
100 g of cream contain:
Active ingredients: triamcinolone benetonide 0.03 g; fusidic acid g 2.
Excipients: white stringy petroleum jelly; fattylan (esters of high molecular weight fatty acids and alcohols); butylated hydroxyanisole; antifoam silicone; sorbic acid; disodium ethylenediamine tetracetate; tween 80; distilled water.
Pharmaceutical form and packaging
20 g tube of cream.
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
DERMOMYCIN CORT 0.03% + 2% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active principles
Triamcinolone benetonide (TBI) 0.03 g;
fusidic acid 2 g.
For excipients see 6.1.
03.0 PHARMACEUTICAL FORM
20 g tube of cream.
30 g tube of cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Therapy of bacterial pyoderma characterized by an exaggerated inflammatory component, in order to simultaneously combat the causative agent and hyperreactivity. Prevention and therapy of secondary impetiginization of all primitively uninfected allergic and dysreactive dermatoses.
04.2 Posology and method of administration
Clean the affected skin area, then apply a layer of cream 2-3 mm high and rub lightly. The operation should be repeated initially 3 times a day, then 2 times, once in the morning and once in the evening.
04.3 Contraindications
Known hypersensitivity to any component of the product.
Corticosteroid preparations are contraindicated in subjects suffering from cutaneous TB and Herpes simplex, as well as from viral and fungal diseases with skin localization.
04.4 Special warnings and appropriate precautions for use
The epicutaneous application of cortisones in the treatment of extensive dermatosis and for prolonged periods can cause systemic absorption; this occurrence occurs more easily when the occlusive bandage is used. In newborns, the diaper can act as an occlusive bandage. In the presence of a super- skin infection appropriate cover therapy should be instituted.
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena.
Avoid ophthalmic use and application in the external ear canal in case of tympanic perforation.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
Do not report.
04.6 Pregnancy and lactation
In pregnant women and in very early childhood, the product should be administered in cases of real need, under direct medical supervision.
04.7 Effects on ability to drive and use machines
There are no known negative effects of DERMOMYCIN CORT on 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 sensations, itching, irritation, dry skin, skin atrophy, acne rash, hypopigmentation, atrophy and striae localized to the intertriginous areas treated for a long period of time with occlusive dressing.
04.9 Overdose
There are no known overdose phenomena from DERMOMYCIN CORT.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
DERMOMYCIN CORT results from the association of a steroid expressly studied for local use and an antibiotic particularly active in bacterial skin infections. Both components were chosen because they are electively active on the skin by virtue of their particular chemical-physical characteristics.
The steroid is Triamcinolone benetonide (16α, 17α acetonide-21 (β-benzoyl-amino) isobutyrate) (TBI). The TBI is absorbed by the skin layers where it fully carries out its pharmacological activity, without however passing appreciably into the general circulation in an active form. TBI carries out an intense anti-inflammatory, anti-allergic and anti-itch activity and is generally well tolerated. Even for administrations many times higher than those usable in clinical practice, it did not present systemic side effects.
This property is particularly interesting in dysreactive dermatoses that require prolonged treatments. Even in these circumstances the TBI does not change any of the biological constants and functions of the organism.
The antibiotic is represented by fusidic acid, which is extremely active on bacteria commonly responsible for pyoderma in general and especially on staphylococcus, including strains resistant to other antibiotics. Fusidic acid also has its own particular property which places it as a first choice antibiotic in skin infections. By virtue of its steroid structure it easily penetrates, through the layers of the skin, through mucous and purulent secretions and necrotic tissues. it finds, for example, in the scabs in a concentration sufficient to carry out its antibacterial activity. Fusidic acid is absolutely non-toxic and has no allergenic activity. The addition of this antibiotic widens the field of application of the ointment, allowing it to attack even dermatoses partially or totally sustained by infectious agents.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
White stringy petroleum jelly, fattylan (esters of high molecular weight fatty acids and alcohols), butylhydroxyanisole, antifoam silicone, sorbic acid, disodium ethylenediamine tetracetate, tween 80, distilled water.
06.2 Incompatibility
None.
06.3 Period of validity
36 months.
06.4 Special precautions for storage
Not required.
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube of 20 g of cream.
Aluminum tube of 30 g of cream.
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
AVANTGARDE S.p.A.
Via Pontina km 30,400 - 00040 Pomezia.
08.0 MARKETING AUTHORIZATION NUMBER
20 g tube of AIC cream n. 022705038
30 g tube of AIC cream n. 022705040
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Authorization: December 1972 (20 g)
July 2014 (30 days)
Renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
July 2014
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