Instructions for use Tyrozur powder for transdermal use, 20 g vial
Composition
active ingredient: tyrothricin,
1 g of powder contains 1 mg of tyrothricin;
Excipients: lactose monohydrate, macrogol, colloidal anhydrous silicon dioxide.
Dosage form
Skin powder.
Main physicochemical properties: white free-flowing powder.
Pharmacotherapeutic group
Antibiotics for topical use.
ATX code D06A X08.
Pharmacological properties
Pharmacodynamics
Tyrothricin is a compound of various cyclic and linear polypeptides that exhibit antibacterial activity and are produced as an endotoxin by the anaerobic spore-forming Bacillus brevis. This compound contains up to 70–80% tyrocidins (basic cyclic decapeptides) and up to 20–30% gramicidins (neutral linear pentadecapeptides).
Active mainly against gram-positive bacteria Staph. aureus MSSA, Staph. aureus MRSA, Staph. Haemolyticus, Strep. Pyogenes, Strep. Viridans, Enterococcus faecalis, Diplococcus pneumoniae, Corynebact. spp., Neisseria meningitides, some strains of Neisseria gonorrhoeae, fungi and Trichomonas, as well as some gram-negative bacteria and some species of fungi, including Candida.
Tyrothricin has a dose-dependent bacteriostatic or bactericidal effect against microorganisms such as Clostridia.
The release of substances such as nitrogen and phosphates from bacterial cells ensures the effectiveness of tyrocidine. Similar to cationic detergents, tyrocidine destroys the osmotic barrier of the bacterial cell membrane. Due to the direct effect on the bacterial cell wall, the action of the drug is not limited to the inhibition of growth or cell division, but also determines the bactericidal effect of tyrocidine.
In addition, gramicidins form cation channels in the cell membrane of bacteria, which leads to the loss of potassium and, as a result, to a change in the intracellular concentration of cations and cytolysis. A component such as gramicidin further causes a disruption of phosphorylation processes in the cellular respiratory chain.
Due to the special mechanism of action of tyrothricin, which is not observed in systemic antibiotics, cross-resistance does not occur.
Tyrozur powder accelerates the wound healing process by cleansing the wound bed, as well as stimulating granulation and epithelialization processes.
Pharmacokinetics
It is not known to what extent tyrothricin may be absorbed systemically. High concentrations have been found in the stratum corneum of the skin (after application to an intact surface) and directly in the wound.
Indication
Superficial wounds with minor exudate and the presence of superinfection caused by pathogenic microorganisms sensitive to tyrothricin, such as lacerations, scratches, abrasions.
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
Unknown.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
Use during pregnancy or breastfeeding.
There are no data on the use of Tyrozur powder during pregnancy. Adequate studies of the effect of tyrothricin on reproductive function in animals have not been conducted. The degree of systemic absorption of tyrothricin after its application to the skin surface is unknown, therefore it should be used with caution during pregnancy. The drug should be used during pregnancy only after assessing the benefit/risk ratio, in small amounts and for a short period of time.
It is not known whether tyrothricin passes into breast milk after its cutaneous application, therefore, during breastfeeding it should be used with caution, in small amounts and for a short period of time. During breastfeeding, Tyrozur, powder, should not be applied to the breast area. Contact of the child with areas of skin on which the powder has been applied should be avoided.
Method of administration and doses
Sprinkle a thin layer of powder on the affected areas of the skin once or twice a day and cover them with a bandage if necessary.
The duration of treatment is determined individually, depending on the course of the disease. If improvement is not observed after a week of use of the drug, then the treatment should be reviewed.
Children
If necessary, Tyrozur powder can be used in children of any age.
Overdose
No cases of overdose have been reported.
Adverse reactions
Skin irritation, allergic reactions including erythema, urticaria, contact dermatitis.
Expiration date
3 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
20 g of powder in a bottle; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Engelhard Arcnaymittel GmbH & Co. KG.
Location of the manufacturer and its business address
Herzbergstrasse 3, 61138 Niederdorfelden, Germany
