Tyrozur

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TYZOSUR (TYROSUR®)

Composition:

Active substance: tyrothricin,

1 g of powder contains 1 mg of tyrothricin;

Excipients: lactose monohydrate, macrogol, colloidal anhydrous silicon dioxide.

Pharmaceutical form. Topical powder.

Main physico-chemical properties: white free-flowing powder.

Pharmacotherapeutic group. Antibiotics for local use.

ATC code D06AX08.

Pharmacological properties.

Pharmacodynamics.

Tyrothricin is a compound of various cyclic and linear polypeptides exhibiting antibacterial activity, produced as an endotoxin by anaerobic spore-forming Bacillus brevis. This compound contains up to 70–80% tyrocidines (main cyclic decapeptides) and up to 20–30% gramicidines (neutral linear pentadecapeptides).

It is primarily active against Gram-positive bacteria such as Staph. aureus MSSA, Staph. aureus MRSA, Staph. haemolyticus, Strep. pyogenes, Strep. viridans, Enterococcus faecalis, Diplococcus pneumoniae, Corynebact. spp., Neisseria meningitidis, certain strains of Neisseria gonorrhoeae, fungi, and trichomonads, as well as some Gram-negative bacteria and certain fungal species including Candida.

Tyrothricin exerts dose-dependent bacteriostatic or bactericidal effects 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 disrupts the osmotic barrier of the bacterial cell membrane. By directly affecting the bacterial cell wall, the drug's action is not limited to inhibition of cell growth or division, but also results in the bactericidal effect of tyrocidine.

In addition, gramicidines form cationic channels in the bacterial cell membrane, leading to potassium loss and, consequently, to changes in intracellular cation concentrations and cytolysis. The component gramicidin further disrupts phosphorylation processes in the cellular respiration chain.

Due to the unique mechanism of action of tyrothricin, which differs from that of systemic antibiotics, cross-resistance does not occur.

Tyrozur powder accelerates wound healing by cleansing the wound bed and stimulating granulation and epithelialization processes.

Pharmacokinetics.

The extent to which tyrothricin may be systemically absorbed is unknown. High concentrations have been detected in the stratum corneum of the skin (after application to intact skin) and directly within the wound.

Clinical characteristics.

Indications. Superficial wounds with minimal exudate and presence of superinfection caused by pathogens sensitive to tyrothricin, such as lacerations, scratches, and abrasions.

Contraindications. Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interactions. Unknown.

Usage characteristics.

Use during pregnancy or breastfeeding.

There are no data on the use of Tyrozur powder during pregnancy. Adequate studies on the effect of tyrothricin on reproductive function in animals have not been conducted. Systemic absorption of tyrothricin following topical application to the skin is unknown; therefore, it should be used with caution during pregnancy. The product should be used during pregnancy only after careful assessment of the benefit-risk ratio, in small amounts and for a short duration.

It is unknown whether tyrothricin passes into breast milk following topical application; therefore, it should be used with caution during breastfeeding, in small quantities and for a short period of time. Tyrozur powder should not be applied to the breast area during breastfeeding. Contact between the infant and skin areas treated with the powder should be avoided.

Ability to influence reaction rate while driving or operating machinery. No effect.

Method of Administration and Dosage.

Once or twice daily, sprinkle a thin layer of the powder onto the affected areas of skin and, if necessary, cover with a dressing.

The duration of treatment is determined individually, depending on the course of the disease. If no improvement is observed after one week of using the medication, the treatment should be reevaluated.

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.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging. 5 g or 20 g of powder in a bottle; 1 bottle in a cardboard box.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

Engelhard Arzneimittel GmbH & Co. KG

Engelhard Arzneimittel GmbH & Co. KG

Manufacturer's address and place of business.

Herzbergstrasse 3, 61138 Niederdorfelden, Germany

Herzbergstrasse 3, 61138 Niederdorfelden, Germany