Translation of the instructions can be
NAFTIDERYL cutaneous solution 1%
Instruction
For medical use of the medicinal product
Naftideryl
(Naphthyridinyl)
Composition:
Active ingredient: naftifine hydrochloride;
1 ml of solution contains 10 mg of naftifine hydrochloride;
excipients: propylene glycol, ethanol 96%, purified water.
Dosage form.
The solution is topical.
Main physicochemical properties: transparent solution from colorless to light yellow with the smell of ethanol.
Pharmacotherapeutic group.
Antifungal agents for use in dermatology.
PBX code D01A E22.
Pharmacological properties.
Pharmacodynamics.
Naftideril is an antifungal agent of the allylamine class, the mechanism of action of which is associated with the inhibition of the action of ergosterol.
Naftideril is active against dermatophytes such as Trichophyton, Epidermophyton and Microsporum, yeasts (Candida), molds (Aspergillus) and other fungi (e.g. Sporothrix Schenckii). Naftideril exhibits fungicidal activity against dermatophytes and Aspergillus in vitro, and fungicidal or fungistatic activity against yeasts, depending on the strain of the microorganism.
Naftideryl also exhibits antibacterial activity against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections along with mycotic lesions.
In addition, Naftideryl has anti-inflammatory properties and helps to quickly eliminate symptoms of inflammation and itching.
Pharmacokinetics.
Due to the rapid penetration of the drug into the skin and the formation of stable antifungal concentrations in different layers of the skin, Naftideryl can be used once a day.
Clinical characteristics.
Indication.
Local treatment of fungal infections caused by pathogens sensitive to naftifine:
Fungal infections of the skin and skin folds; interdigital mycoses; fungal infections of the nails (onychomycoses); cutaneous candidiasis; tinea versicolor; inflammatory dermatomycoses, with or without itching; mycosis of the external auditory canal.
Contraindication.
Hypersensitivity to naftifine or propylene glycol. The drug should not be applied to the wound surface. Do not use for eye treatment.
Interaction with other drugs and other types of interactions.
No cases of interaction with other drugs have been identified.
Application features.
The drug should only be used externally!
The drug contains ethanol, so avoid getting the solution in the eyes and on open wounds.
Use during pregnancy or breastfeeding.
Provided the drug is used in accordance with the instructions, the effect of Naftideril on the fetus and newborn is unlikely. The results of teratogenicity studies indicate the absence of any embryotoxic effect of Naftifine. The drug can be used during pregnancy or breastfeeding only after a careful assessment of the benefit/risk ratio by a doctor.
Breastfeeding women should avoid contact of the drug with the skin and digestive tract of the baby.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Unknown.
Method of administration and doses.
Naftideryl solution should be applied to the affected skin surface once a day after it has been thoroughly cleaned and dried, capturing approximately 1 cm of healthy skin around the affected area.
Duration of treatment: for dermatomycoses - 2 - 4 weeks (if necessary - up to 8 weeks); for candidiasis - 4 weeks; for nail infections - up to 6 months.
For fungal nail diseases, the drug is recommended to be used 2 times a day. Before the first use, it is necessary to remove as much of the affected part of the nail as possible with scissors or a nail file (to facilitate this procedure, on the recommendation of a doctor, the nails can be treated with a special softening agent).
In case of mycoses of the external auditory canal, treatment should last at least 14 days. Local treatment should be carried out by inserting cotton turundas moistened with Naftideryl solution into the ear for 5-8 minutes 1-2 times a day.
To prevent relapse, treatment with the drug should be continued for at least 2 weeks after the main symptoms of the disease have disappeared.
Children.
Data on the efficacy and safety of the drug in children are insufficient, therefore it is not recommended to prescribe Naftideryl to patients in this age category.
Overdose.
Symptoms of overdose: increased side effects.
Therapy is symptomatic.
Adverse reactions.
In rare cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation. Side effects are usually reversible and do not require discontinuation of treatment.
Expiration date.
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions.
Store in the original packaging at a temperature not exceeding 30 degrees Celsius.
Keep out of reach of children.
Packaging.
10 ml in a bottle. 1 bottle in a pack.
Vacation category.
Without a prescription.
Producer.
Ciao "technologist".
Location of the manufacturer and address of its place of business.
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna street, building 8.
