Instructions for Estezifin cutaneous solution 1% bottle 25 ml No. 1
Composition
active ingredient: naftifine hydrochloride;
1 ml of solution contains 10 mg of naftifine hydrochloride, calculated on 100% dry matter;
Excipients: propylene glycol, ethanol 96%, purified water.
Dosage form
The solution is topical.
Main physicochemical properties: transparent solution from colorless to light yellow with an alcohol odor.
Pharmacotherapeutic group
Antifungal agents for use in dermatology. ATX code D01A E22.
Pharmacological properties
Pharmacodynamics
Estezifin is an antifungal agent of the allylamine class, the mechanism of action of which is associated with the inhibition of the action of ergosterol.
Estesifin is active against dermatophytes such as Trichophyton, Epidermophyton and Microsporum, yeasts (Candida), molds (Aspergillus) and other fungi (e.g. Sporothrix Schenckii). Naftifine has fungicidal activity against dermatophytes and Aspergillus in vitro, and fungicidal or fungistatic activity against yeasts, depending on the strain of the microorganism.
Estesifin also exhibits antibacterial activity against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections along with mycotic lesions.
In addition, Estesifin has anti-inflammatory properties, which helps to quickly eliminate symptoms of inflammation and itching.
Pharmacokinetics
Naftifine hydrochloride is rapidly absorbed and forms stable antifungal concentrations in different layers of the skin. Approximately 4% of the dose applied to the skin is absorbed, so the systemic exposure of the active substance is very low. Only trace amounts of naftifine are found in blood plasma and urine. The active substance is almost completely metabolized; the metabolites have no antifungal activity and are excreted in feces and urine. The half-life is 2–4 days.
Indication
Topical 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; lichen planus; inflammatory dermatomycoses, with or without itching.
Contraindication
Hypersensitivity to naftifine, propylene glycol or any other component of the drug. The drug should not be applied to the wound surface. Do not use for eye treatment.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
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.
The solution contains propylene glycol, which may cause skin irritation.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
There are no or limited amount of data from the use of naftifine in pregnant women. Animal studies do not indicate direct or indirect harmful effects of the drug on reproductive function. The drug should be used during pregnancy or breastfeeding only if clearly needed after a careful benefit/risk assessment by a physician.
Method of administration and doses
Estesifin 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 softener).
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 Estesifin to patients in this age category.
Overdose
Acute overdose with topical application of naftifine has not been observed.
Systemic intoxication with external use of the drug is unlikely due to the fact that a small amount of the active substance is absorbed through the skin.
In case of accidental ingestion of the drug, symptomatic treatment should be initiated.
Adverse reactions
The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated from the available data).
General disorders: frequency unknown - in rare cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation.
2 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 °C.
Keep out of reach of children.
Packaging
25 ml in a bottle. 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
