Instructions Cyclocutan protective nail polish with antifungal effect 3 g
Composition
active ingredient: ciclopirox;
1 g of solution contains 80 mg of ciclopirox;
excipients: ethyl acetate, isopropyl alcohol, Gantrez ES-435 (monobutyl ether poly (methyl vinyl ether/maleic acid) in isopropyl alcohol (1:1 by weight).
Dosage form
Medical nail polish.
Main physicochemical properties: clear yellowish solution.
Pharmacotherapeutic group
Antifungals for use in dermatology. Other antifungals for topical use. Ciclopirox. ATX code D01A E14.
Pharmacological properties
Pharmacodynamics
The results of studies studying the mechanism of action indicate that the fungicidal activity of ciclopiroxolamine is due to the inhibition of the uptake of essential cellular elements by cells while simultaneously inducing the release of other important cellular elements.
Ciclopiroxolamine rapidly accumulates in fungal cells and binds irreversibly to specific structures and organelles, such as cell membranes, cell membranes, mitochondria, ribosomes, and microsomes.
No signs of biotransformation of ciclopiroxolamine under the action of fungal cells were detected.
Comparative studies have demonstrated that ciclopirox and ciclopiroxolamine have similar effects on the corresponding spectrum of pathogenic fungi that cause dermatomycoses.
Pharmacokinetics
Penetration of ciclopirox from medicated nail polish into cut parts of human fingernails affected by onychomycosis
The release of the radiolabeled (14C) active substance from the medicated nail polish and its penetration into the cut parts of the nails affected by onychomycosis led to the accumulation within 24-48 hours of concentrations in the tissues of the deeper layers of the nails that were equivalent to 2-10 minimal inhibitory concentrations for pathogens causing onychomycosis.
In vivo study investigating the penetration of ciclopirox from medicated nail polish into healthy human fingernails
Since the use of cut nail parts for the study gives a very limited idea of the use of the drug in vivo, the penetration of ciclopirox from the varnish into the nail plate of healthy fingernails was studied. A biological test was performed to detect the active substance (inhibition of the growth of Candida pseudotropicalis). As a result, the concentrations of ciclopirox in different layers of the nail plate were recorded, sufficient to completely block the growth of the microorganism under study. Stability was established by the diffusion gradient and determined after 14 days. In addition, a relatively homogeneous distribution of the active substance in the nail plate was noted, including the involvement of remote areas. In this study, it was found that ciclopirox, which penetrates the nail plate, retains its microbiological activity.
There are no data on the extent of resorption through the nail plate and systemic absorption of ciclopirox. However, it is believed to be much lower than 1.3% (cutaneous resorption).
There was no evidence that the toxicological data collected for ciclopiroxolamine were not transferable to the use of ciclopirox.
Indication
Fungal nail infections.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the drug.
Due to the lack of clinical experience, the drug is not used in children, pregnant women, or breastfeeding women.
Special safety precautions
Avoid getting nail polish in your eyes, ears, and mucous membranes.
The use of nail polish and false nails should be avoided during treatment with the drug.
Interaction with other medicinal products and other types of interactions
No interactions of the drug with other drugs have been reported.
Application features
Cyclocutane is for external use only.
The drug should be applied only to the nails.
Avoid contact with eyes and mucous membranes.
In case of sensitization, treatment should be discontinued and appropriate therapy should be prescribed.
During the treatment of onychomycosis, if multiple nails are affected (more than 5 nails), if more than 2/3 of the nail plate is changed, and in cases of certain factors such as diabetes and immunodeficiency disorders, it is necessary to consult a doctor.
Use caution when performing nail treatments (cleaning and removing affected parts) in patients with insulin-dependent diabetes or a history of diabetic neuropathy due to the risk of losing affected nails.
The bottle with the drug must be tightly closed after use to prevent the solution from drying out.
Ability to influence reaction speed when driving vehicles or other mechanisms
Cyclocutan® does not affect the reaction speed when driving or using other mechanisms.
Use during pregnancy or breastfeeding
Given the lack of clinical experience, Cyclocutan® should not be used during pregnancy and breastfeeding.
Method of administration and doses
Dosage
Unless otherwise prescribed, a thin layer of Cyclocutan® is applied to the affected nail every other day for the first month. This regimen ensures that the nails are saturated with the active substance.
During the second month of use, the frequency of applications can be reduced to at least twice a week, and starting from the third month of treatment, to once a week.
Method of application
Before starting to use Cyclocutan®, it is necessary to remove as many affected areas of the nail plate as possible using scissors or the disposable nail file provided in the kit.
To apply the medicated nail polish, you need to use the reusable spatulas provided in the kit. Ten reusable spatulas are located together in one cassette. Before use, one reusable spatula should be removed from the cassette. The package also contains a spatula holder. Each spatula and holder must be connected to ensure more convenient application of the nail polish.
The spatula is dipped with the perforated end into the glass bottle before treating each nail, without removing the remnants of the drug from the neck of the bottle (due to the risk of the screw cap sticking to the bottle).
Using a spatula, Cyclocutan® is applied evenly to the entire surface of the affected nail. The bottle is tightly closed immediately after use to prevent the solution from drying out. To be able to reuse the spatula, it is necessary to clean it with a cleansing swab after nail treatment.
Once a week during the treatment period, the nail polish layer is completely removed with a cleaning swab. Again, as much of the affected nail material as possible is removed.
If the integrity of the varnish layer has been compromised in the interval between treatments, it is sufficient to apply Cyclocutan® to the areas with damaged coating.
After use, the bottle with Cyclocutan® must be tightly closed to prevent the solution from drying out.
Contact of the solution with the threads on the neck of the vial should be avoided as this may cause the screw cap to stick to the vial.
Duration of treatment
The duration of treatment depends on the severity of the mycosis, but should not exceed 6 months. Usually this period is enough to destroy pathogenic microorganisms that cause fungal nail infections. The decision to continue treatment is made by the doctor.
Children
There is no experience of use in children.
Overdose
Not described.
Adverse reactions
Adverse reactions are classified by frequency according to the following criteria:
Rare (≥1/10,000 to <1/1,000).
Rare (<1/10,000).
On the part of the immune system: rarely - allergic contact dermatitis.
Skin and subcutaneous tissue disorders: In isolated cases, redness and peeling of the skin around the nails in direct contact with Cyclocutan® have been reported.
Prolonged use of the drug may lead to sensitization, which leads to undesirable effects. In such cases, treatment should be discontinued and a doctor should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions is very important. Healthcare professionals and patients should report any suspected adverse reactions via the national reporting system.
Expiration date
36 months.
After opening the bottle: 6 months.
Storage conditions
Store at a temperature not exceeding 30°C. Keep out of the reach of children.
Packaging
3 g of medicated nail polish in a bottle. 1 bottle in a set with 10 spatulas in a cassette, spatula holder, swabs and nail files in a pack.
Vacation category
Without a prescription.
Producer
mibe GmbH Arcnaymittel.
Location of the manufacturer and its business address
Münchenerstrasse 15, Brena, Saxony-Anhalt, 06796, Germany.
