Фуцидин® cream
Producer: Nycomed Austria GmbH (Nikomed Austria Gmbh) Austria
Code of automatic telephone exchange: D06AX01
Release form: Soft dosage forms. Cream.
General characteristics. Structure:
Active agent: fuzidovy acid гемигидрат 20,4 mg (in terms of acid anhydrous – 20,0 mg).
Excipients: cetyl alcohol – 111 mg; глицерол 85% – 111 mg; liquid paraffin – 111 mg; white soft paraffin – 56 mg; polysorbate of 60 - 56 mg; q.s Acidum hydrochloricum. to рН 5; potassium sorbate – 2,7 mg; butylhydroxyanisole – 0,04 mg; water прибл. 531 mg.
Description:
Homogeneous cream from white till almost white color.
Pharmacological properties:
Pharmacodynamics. Bacteriostatic antibiotic.
Fuzidovy acid concerns to group of Fusidinums, antimicrobic connections which mechanism of action is connected with disturbance of synthesis of protein in a bacterial cell.
Gram-positive bacteria and gram-negative cocci, for example, of Staphylococcus aureus are sensitive Staphylococcus epidermidis to fuzidovy acid (including Methicillinum - resistant strains), Nocardia asteroides, Corynebacterium minutissimum, Streptococcus pyogenes, Pseudomonas spp, Clostridium spp., Neisseria meningitidis, Neisseria gonorrhoeae, Is inactive concerning Escherichia coli, Salmonella spp., Proteus spp., etc. gram-negative bacteria, and also protozoa and mushrooms.
Pharmacokinetics. At external use system absorption of fuzidovy acid low. Does not get to a system blood stream.
Indications to use:
Dermatitis in the presence of a bacterial infection or suspicion on it: atopic dermatitis, seborrheal dermatitis, simple contact dermatitis, allergic dermatitis, eczema, chronic deprive, a red diskoidny lupus.
Route of administration and doses:
Outwardly.
At adults and children since the birth to 18 years cream is applied on affected areas of skin with a thin layer by 3-4 times a day.
When using gauze bandages the frequency of drawing can be reduced to 1-2 times a day.
Duration of treatment depends on a form and disease severity and averages 7-14 days.
Features of use:
Not to apply cream Fucidinum on skin in eyes as fuzidovy acid, at hit in eyes, causes irritation of a conjunctiva.
Фуцидин® cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate which can serve as the reason of emergence of local allergic skin reactions (for example, contact dermatitis).
Butylhydroxyanisole can also serve as the reason of emergence of irritation of eyes and mucous membranes.
When using fuzidovy acid bacterial resistance can develop. As well as at other antibiotics, the long or periodically repeating use can increase risk of development of resistance to antibiotics.
Influence on ability to manage vehicles and mechanisms
Influence on ability to manage vehicles and difficult mechanisms is not revealed.
Side effects:
Frequency of side effects belongs to the category very seldom – side effects can be expected approximately at 5% of patients.
Data on adverse side reactions depending on frequency from emergence are included below
Very often ≥ 1/10
Often ≥ 1/100 and <1/10
Infrequently ≥ 1/1000 and <1/100
Seldom ≥ 1/10000 and <1/1000
Very seldom <1/10000
Disturbances from skin and hypodermic fabrics:
Infrequently:
Rash (erythematic, makulopapulezny, pustular), irritation of skin, including pain, burning sensation, feeling of a pricking on skin, an itch, a xeroderma, contact dermatitis,
Seldom:
small tortoiseshell, Quincke's disease, eczema, periorbital hypostasis, erythema.
Disturbances from immune system:
Seldom:
Allergic reactions.
Disturbances from an organ of sight:
Seldom:
Irritation of a conjunctiva.
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.
Interaction with other medicines:
Are not revealed.
Contraindications:
Hypersensitivity to drug components.
With care: pregnancy, lactation period.
Overdose:
The overdose is improbable.
Storage conditions:
To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after a period of validity.
Issue conditions:
According to the recipe
Packaging:
Cream for external use of 2%.
15 g of drug in a tuba aluminum, varnished from within with the screw-on polyethylene cover.
1 tuba together with the application instruction in a cardboard pack.