Name:
Fungasept solution dnar.prim.10mgml in vial 10ml in pack No. 1 CompositionEach vial (10 ml) contains the active substance – naftifine hydrochloride – 100 mg; excipients – propylene glycol, ethyl alcohol 50%.
Description:
Transparent, colorless or slightly yellow solution with an ethanol odor. Pharmacotherapeutic group Antifungal agents for local use. ATX code: D01AE22. Pharmacological properties Pharmacodynamics The active substance naftifine is intended for external use in mycoses. The fungicidal action of naftifine is based on the blockade of the synthesis of ergosterol (a membrane component) by suppressing the synthesis of the enzyme squalene epoxidase. Under in vitro conditions, naftifine demonstrates fungicidal activity against the following organisms: Trichophyton spp., Microsporon spp., Epidermophyton floccosum. Naftifine is moderately active against yeast (Candida species), mold (Aspergillus species) and other fungi (eg Sporothrix schenkii). It also exhibits antibacterial activity against gram-positive and gram-negative microorganisms, which often accompany mycoses. In clinical use, the anti-inflammatory effect of naftifine was noted, due to which signs of inflammation, especially itching, quickly disappear. Pharmacokinetics When applied to the skin, only 4% of the dose is absorbed, so systemic exposure is very low. In plasma and urine, naftifine is found in trace amounts. Indications for use Local treatment of fungal infections caused by pathogens sensitive to naftifine: – fungal infections of the skin and skin folds (tinea manuum, tinea pedis, tinea corporis, tinea inguinalis), with or without associated itching; – fungal nail infections (onychomycosis, tinea unguium); – skin candidiasis; pityriasis versicolor. Contraindications – hypersensitivity to naftifine or excipients; – open wound surface. Precautions Fungasept is for external use only. It can not be used in ophthalmic practice, as well as applied to open wounds. To eliminate a fungal infection (mycosis), it is recommended to take the following precautions: 1. Fungi can get on clothes and / or socks that come into contact with the affected skin / nail area, therefore, clothes and / or socks should be changed every day. 2. Keeping the affected skin/nail surface dry provides good protection against the spread of fungal infection. It is not recommended to cover the affected area with a dense cloth or accessories that restrict or prevent ventilation (for example, stockings made from synthetic fibers, tight shoes). The affected area of the skin/nail should be thoroughly dried after washing. Towels, clothing and/or socks in contact with the affected surface should also be changed daily. 3. In the case of a fungal disease of the feet, you should not walk barefoot at home or in public places to prevent re-infection or the spread of pathogenic pathogens. 4. Saunas or steam baths can be visited only after complete disposal of the fungal infection. If no clinical improvement is observed within 4 weeks after the use of the drug Fungasept, you should consult your doctor. The therapeutic approach needs to be revised. Method of application and doses 2-3 drops of the drug are applied to the affected surface of the skin / nail, capturing the adjacent healthy areas of the skin / nail to prevent the spread of infection. Fungal infections of the skin The solution is applied 1 time per day to the affected areas of the skin, which must first be cleaned and thoroughly dried. Duration of treatment: – fungal infections of the skin and skin folds – up to 4 weeks; – interdigital mycosis of the hands and feet – from 4 to 8 weeks; – skin candidiasis – 4 weeks; pityriasis versicolor – up to 2 weeks. After the manifestation of the clinical effect, namely the disappearance of itching and burning, to prevent recurrent infection, treatment should be continued for at least 2 weeks. Fungal infections of the nails on the hands and feet (onychomycosis) The solution is applied 2 times a day to the affected surface of the nail plates, which before that must be cleaned, thoroughly dried and trimmed as much as possible. The duration of treatment is determined by the rate of nail plate regrowth and can range from 3 to 6 months until the new nail is fully grown. Fungasept is recommended to be used under a breathable dressing (plaster, bandage, etc.), but should not be used under an occlusive dressing. Children and adolescents The safety and efficacy of naftifine in children and adolescents under 18 years of age has not been proven (experience is insufficient). Patients with renal or hepatic insufficiency Dose adjustment is not required. Elderly patients Dose adjustment is not required. Duration of use To prevent recurrence of infection, treatment is continued for at least two more weeks after clinical recovery. Patients should be informed about the necessary hygiene measures to prevent re-infection. Drug Interactions Interactions with other medicinal substances or alcohol have not been noted. Side effectsThe frequency of occurrence of adverse reactions is indicated as: very often (? 1/10), often (? 1/100 to < 1/10), infrequently (from? 1/1000 to < 1/100), rarely (? 1/10000 up to < 1/1000), very rarely (< 1/10000). General disorders and disorders at the injection site: the frequency is unknown: dry skin, burning and burning, erythema, itching, local irritation. Adverse reactions are reversible and do not require discontinuation of treatment. Application during pregnancy and lactation As a precaution, the use of Fungasept during pregnancy and lactation should be avoided. Influence on the ability to drive vehicles and work with mechanisms So far, there have been no reports of effects. Overdose Acute overdose and systemic intoxication with external use of naftifine are unlikely. Treatment In case of accidental ingestion, appropriate symptomatic treatment is recommended. Upakovka10 ml in a bottle from glass. Each vial, together with the leaflet, is placed in a cardboard box (packaging No. 1). Storage conditions In a place protected from light, at a temperature not exceeding 25? Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date. Terms of dispensing from pharmaciesWithout a prescription. Buy Fungasept solution for external use 10mg/ml 10ml No. 1 Price for Fungasept solution for external use 10mg/ml 10ml No. 1
INN | NAFTIFIN |
---|---|
The code | 102 278 |
Barcode | 4 810 201 015 590 |
Dosage | 10mg/ml 10ml |
Active substance | Naftifine g/chl |
Manufacturer | Borisovsky ZMP, Belarus |
Indications Applications | Local treatment of fungal infections caused by pathogens sensitive to naftifine: – fungal infections of the skin and skin folds (tinea manuum, tinea pedis, tinea corporis, tinea inguinalis), with or without associated itching; – fungal nail infections (onychomycosis, tinea unguium); – skin candidiasis; pityriasis versicolor. |
Contraindications | – hypersensitivity to naftifine or excipients; – open wound surface. |
Side effects | The frequency of occurrence of adverse reactions is indicated as: very often (? 1/10), often (? 1/100 to < 1/10), infrequently (from? 1/1000 to < 1/100), rarely (? 1/10000 to < 1/1000), very rare (< 1/10000). General disorders and disorders at the injection site: the frequency is unknown: dry skin, burning and burning, erythema, itching, local irritation. Adverse reactions are reversible and do not require discontinuation of treatment. |
Use during pregnancy and lactation | unknown |
Application Gender | Any |
Release Form | Solution |
Main Active Substances | naftifine hydrochloride |
Composition Means | Each bottle (10 ml) contains the active substance – naftifine hydrochloride – 100 mg; excipients – propylene glycol, ethyl alcohol 50%. |
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