Active ingredients: Sodium fusidate
DERMOMYCIN 2% CREAM
Why is Dermomycin used? What is it for?
Pharmacotherapeutic group
The sodium fusidate contained in DERMOMYCIN is an antibiotic with a steroid structure, active on gram-positive cocci, staphylococci, (including strains resistant to penicillin and other antibiotics) pneumococci and streptococci.
Indications
Pyoderma in general: impetigo, boils, folliculitis, abscesses, hydroxyadenitis, sycosis of the beard, wounds and abrasions, all infected if caused by staphylococcus.
Contraindications When Dermomycin should not be used
Individual ascertained hypersensitivity to the product. Rosaceae.
Precautions for use What you need to know before taking Dermomycin
The product should not be used in case of Piocianeo or Proteus infections, as these germs are always resistant to the antibiotic. The use of topical products, especially if prolonged or repeated, can give rise to irritation or sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy, under direct medical supervision. As with all antibiotics, there is a risk of superinfection or mycosis.
Use in case of pregnancy and lactation
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.
Interactions Which drugs or foods can modify the effect of Dermomycin
Sodium fusidate can be associated with other antibiotics to increase antibacterial activity, broaden the spectrum of action and minimize the risk of the appearance of less sensitive or resistant bacterial mutants.
Warnings It is important to know that:
If DERMOMYCIN cream is used to treat facial lesions, care must be taken that the cream itself does not get into the eyes. The product can be used in eczema only if dry and site of superinfection. As with other antibiotics, treatment with DERMOMYCIN can result in superinfections with resistant bacterial agents or fungi, which requires the adoption of adequate therapeutic measures.
This medicinal product contains butylated hydroxyanisole and cetyl alcohol which can cause local skin reactions (eg contact dermatitis); butylhydroxyanisole can also cause irritation of the eyes and mucous membranes.
Effects on ability to drive and use machines
There are no known adverse effects of the drug on the ability to drive or use machines.
Dose, Method and Time of Administration How to use Dermomycin: Posology
2-3 applications per day on the affected area
Overdose What to do if you have taken an overdose of Dermomycin
There are no known phenomena of sodium fusidate overdose.
Side Effects What are the side effects of Dermomycin
DERMOMYCIN cream is usually well tolerated; allergic-based skin rashes may occasionally occur.
Any occurrence of undesirable effects not described in the package leaflet must be promptly reported to the attending physician or pharmacist.
Expiry and Retention
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Warning: do not use the drug after the expiry date indicated on the packaging.
Store at a temperature not exceeding 25 ° C.
Medicines should not be disposed of 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
Composition
100 g of cream contain: Active ingredient: 2 g sodium fusidate. Excipients: light liquid paraffin, soft white paraffin, cetyl alcohol, butylhydroxyanisole, polysorbate 60, purified water, glycerol, potassium sorbate.
Pharmaceutical form and packaging
20 g of 2% 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 2% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contains:
Active principle:
sodium fusidate 2 g.
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Pyoderma in general: impetigo, boils, folliculitis, abscesses, hydroxyadenitis, sycosis of the beard, infected wounds and abrasions, all if caused by staphylococcus.
04.2 Posology and method of administration
2 - 3 applications per day on the affected area.
04.3 Contraindications
Individual ascertained hypersensitivity to the product. Rosaceae.
04.4 Special warnings and appropriate precautions for use
The product should not be used in cases of pyocyanin or proteus infections as these germs are always resistant to the antibiotic. The use of topical products, especially if prolonged or repeated, can give rise to irritation or sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy, under direct medical supervision.
If DERMOMYCIN cream is used to treat facial lesions, care must be taken that the cream itself does not get into the eyes. The product can be used in eczema only if dry and site of superinfection. As with other antibiotics, treatment with DERMOMYCIN can result in superinfections with resistant bacterial agents or fungi, which requires the adoption of adequate therapeutic measures.
This medicinal product contains butylated hydroxyanisole and cetyl alcohol which can cause local skin reactions (eg contact dermatitis); butylhydroxyanisole can also cause irritation of the eyes and mucous membranes.
Keep this medicine out of the reach and sight of children
04.5 Interactions with other medicinal products and other forms of interaction
Sodium fusidate can be associated with other antibiotics to increase antibacterial activity, broaden the spectrum of action and minimize the risk of the appearance of less sensitive or resistant bacterial mutants.
04.6 Pregnancy and lactation
In pregnant women and in very early childhood, the product should be administered in cases of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
There are no known adverse effects of the drug on the ability to drive or use machines.
04.8 Undesirable effects
DERMOMYCIN is usually well tolerated; occasionally allergic-based skin rashes may occur.
04.9 Overdose
There are no known phenomena of overdose from sodium fusidate.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
DERMOMYCIN is an antibiotic isolated from the cultures of a fungus, Fusidium coccineum, extremely active on gram positive cocci, staphylococci (including strains resistant to penicillin and other antibiotics), pneumococci and streptococci. In particular, for staphylococcus, C.M.I. it is very low between 0.03 and 0.12 mcg / ml. The steroid structure gives it surfactant properties.
05.2 Pharmacokinetic properties
Gastro-enteric absorption is rapid. The very high serum rates reach their maximum after 1 - 2 hours and remain at an active level for 6 - 8 hours. The plasma half-life is 4 - 6 hours.
Tissue concentrations are maximal in the liver and bone tissue. In the blood, DERMOMYCIN binds 90 - 95% to plasma proteins so that renal elimination is slow. Only 1% of the taken dose is found in the urine. The main elimination occurs through the entero-hepatic cycle in the metabolized form.
05.3 Preclinical safety data
Acute and chronic toxicity, teratogenesis and haematological modifications have been studied on various animal species (mice, rats, rabbits, dogs). In mice, the LD50 per os is 975 mg / kg, per s.c. of 313 mg / kg, by i.v. of 205 mg / kg, for i.p. of 170 mg / kg. In general, sodium fusidate did not produce any significant functional or anatomical changes in the organs examined.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Light liquid paraffin, soft white paraffin, cetyl alcohol, butyl hydroxyanisole, polysorbate 60, purified water, glycerol, potassium sorbate.
06.2 Incompatibility
Sodium fusidate has no absolute incompatibilities with other drugs.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
20 g tube of 2% sodium fusidate cream
30 g tube of 2% sodium fusidate cream
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Avantgarde S.p.A.
Via Pontina km 30,400 - 00040 Pomezia (Rome)
08.0 MARKETING AUTHORIZATION NUMBER
20 g of 2% cream AIC n. 021266022
30 g of 2% cream AIC n. 021266059
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Authorized: September 1981 (20 g)
July 2014 (30 days)
Renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
July 2014
