Instructions for Elocom cream 0.1% tube 30 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
Ointment.
Main physicochemical properties: pale yellow shiny homogeneous soft ointment with a faint specific odor.
Pharmacotherapeutic group
Other antibiotics for topical use.
ATX code D06A X01.
Pharmacological properties
Pharmacodynamics
Mometasone furoate is a synthetic glucocorticosteroid for topical use with anti-inflammatory, antipruritic, and antiexudative effects.
Pharmacokinetics
During topical application, systemic absorption is insignificant.
Indication
Fuzicutan ointment is indicated for the local treatment of skin infections caused by bacteria sensitive to fusidic acid (see section "Pharmacodynamics"). The ointment should be used for dry lesions and chronic processes.
Contraindication
Hypersensitivity to fusidic acid or to any of the other ingredients of the drug. Do not apply Fuzicutan ointment 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 ointment 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 ointment 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 ointment 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 ointment 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)
Uncommon: (<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
Uncommon: Dermatitis (including contact dermatitis, eczema), rash*, pruritus, erythema.
*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.
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
3 years.
After opening the tube – 6 months.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 °C.
Packaging
Tubes of 30 g No. 1 in a cardboard box.
Vacation category
According to the recipe.
Producer
Schering-Plough Labo N.V., Belgium.
Location of the manufacturer and its business address
Industrial Park 30, Heist-op-den-Berg, 2220, Belgium.
