Instructions Fuzicutan cream 2% tube 15 g
Composition
active ingredient: fusidic acid;
1 g of ointment contains 20 mg of fusidic acid (as fusidic acid hemihydrate);
excipients: white soft paraffin, anhydrous lanolin, cetyl alcohol, mineral oil, alpha-tocopherol, butylhydroxytoluene
Dosage form
Cream.
Main physicochemical properties: white, shiny, homogeneous, soft cream with a faint specific odor.
Pharmacotherapeutic group
Other antibiotics for topical use.
ATX code D06A X01.
Pharmacological properties
Pharmacodynamics
Fusidic acid is an antibiotic formed during the growth of Fusidium coccineum. It disrupts the synthesis of microbial cell protein, depending on the dose, it acts bacteriostatically or bactericidally. The drug has a powerful antibacterial effect on a wide range of gram-positive microorganisms - Staphylococcus spp., Streptococcus spp., Corynebacterium minutissimum and Propionibacterium acnes, including staphylococci resistant to penicillin, streptomycin, chloramphenicol, erythromycin and other antibiotics. Fuzicutan has the property of acting through intact skin. When applied topically, fusidic acid is active against Corynebacteria spp., Neisseria spp, Clostridia spp, Bacteroides spp.
Pharmacokinetics
During topical application, systemic absorption is insignificant.
Indication
Fuzicutan cream is indicated for the topical treatment of skin infections caused by bacteria sensitive to fusidic acid (see section "Pharmacodynamics"). The cream is used for the treatment of weeping skin diseases.
Contraindication
Hypersensitivity to fusidic acid or to any of the other ingredients of the drug. Do not apply Fuzicutan cream to the area around the eyes.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been performed. Interactions with systemic medicinal products are considered to be minimal due to the low systemic absorption of fusidic acid.
Application features
Development of resistance in Staphylococcus aureus has been reported with topical fusidic acid. As with any antibiotic, prolonged or regular use of fusidic acid may increase the risk of antibiotic resistance.
Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. Cetyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis).
If latex condoms are used during treatment with Fuzicutan cream in the anal area or genital area, the condoms' resistance to tearing may decrease under the influence of excipients of white soft paraffin and liquid paraffin, which negatively affects the reliability of this method of contraception.
Ability to influence reaction speed when driving vehicles or other mechanisms
Fusidic acid has no or negligible influence on the speed of reaction when driving or operating other mechanisms.
Use during pregnancy or breastfeeding
The use of Fuzicutan cream during pregnancy or breastfeeding is recommended only in cases where the expected benefit to the mother outweighs the possible risk to the fetus/child. During use during breastfeeding, the drug should be avoided on the skin of the mammary glands.
Method of administration and doses
Adults and children over 2 years of age should apply the cream to the affected areas of the skin 2-3 times a day for 7 days. If there are necrotic masses, they must be removed before applying the drug.
Children
There is no experience with the use of Fuzicutan cream in clinical practice in patients under 2 years of age.
Overdose
Not described.
Adverse reactions
The assessment of the frequency of adverse reactions was carried out based on the results of a pooled analysis of clinical trial data and spontaneous reports.
The most frequently reported adverse reactions during treatment include various skin reactions such as pruritus and rash; less frequently reported are application site reactions such as pain and irritation, which occurred in less than 1% of patients.
Cases of hypersensitivity and angioedema have been reported.
Adverse reactions are listed by MedDRA system organ class, with individual adverse reactions listed in order of frequency, starting with the most frequent. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The corresponding frequency categories of adverse reactions have been compiled based on the following criteria:
Very common (≥1/10)
Common (≥1/100 and <1/10)
Uncommon (≥1/1000 and <1/100)
Rare (≥1/10,000 and <1/1,000)
Isolated (<1/10,000)
Frequency not known (frequency cannot be estimated from the available data)
On the part of the immune system
Rare: Hypersensitivity.
From the organs of vision
Rare: Conjunctivitis.
Skin and subcutaneous tissue disorders
*Various types of rash have been reported, such as erythematous, pustular, vesicular, maculopapular and papular. Cases of generalized rash have also been reported.
Rare: Angioedema, urticaria, blisters.
General disorders and administration site conditions
Uncommon: Application site pain (including burning sensation of the skin), application site irritation.
Children
The frequency, type and severity of adverse reactions in children are expected to be no different from the frequency, type and severity in adults.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of a medicinal product is important. It allows for continuous monitoring of the benefit-risk balance of a medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
Shelf life: 2 years.
After opening the tube – 6 months.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 °C.
Packaging
Cream 5 g or 15 g or 30 g in a tube in a cardboard box.
Vacation category
According to the recipe.
Producer
mibe GmbH Arcnaymittel.
Location of the manufacturer and its business address
Münchenerstrasse 15, Brena, Saxony-Anhalt, 06796, Germany.
