Instructions Estezifin cream 1% tube 15 g
Composition
active ingredient: naftifine hydrochloride;
1 g of cream contains 10 mg of naftifine hydrochloride, calculated on 100% dry matter;
excipients: isopropyl myristate, cetostearyl alcohol, cetyl palmitate, sorbitan laurate, polysorbate 60, benzyl alcohol, sodium hydroxide, purified water.
Dosage form
Cream.
Main physicochemical properties: white, soft or slightly cheesy shiny cream with a slight characteristic odor.
Pharmacotherapeutic group
Antifungal agents for use in dermatology. ATX code D01A E22.
Pharmacological properties
Pharmacodynamics
Estesifin is an antifungal agent of the allylamine class. Its active ingredient is naftifine hydrochloride, the mechanism of action of which is associated with the inhibition of the action of ergosterol.
Naftifine 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 or to any of the excipients of the drug. The drug should not be applied to wound surfaces. Do not use for eye treatment.
Interaction with other medicinal products and other types of interactions
No cases of interaction with other drugs have been identified.
Application features
The drug should be used externally only for nail and skin diseases!
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.
Breastfeeding mothers should prevent the drug from getting on the baby's skin and digestive tract.
Method of administration and doses
Estesifin cream should be applied to the affected skin surface and adjacent areas once a day after it has been thoroughly cleaned and dried, capturing approximately 1 cm of healthy skin around the edges of 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 the amount of active substance absorbed through the skin is insignificant.
In case of accidental ingestion of the drug, symptomatic treatment should be initiated.
Adverse reactions
General disorders: frequency unknown - in rare cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation.
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 ºС.
Keep out of reach of children.
Packaging
15 g in a tube. 1 tube in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 74.
