Fungoterbin, cream 1% 15 g

Pharmacodynamics

Antifungal drug for topical use, it is an allylamine and has a wide spectrum of antifungal activity.

It is characterized by pronounced epidermotropism. The target for terbinafine is cytoplasmic membrane of fungal cell.

Terbinafine acts on the early stages of sterol metabolism, at the level of squalene epoxidase cycle.

Inhibiting the enzyme squaleneepoxidase, terbinafine inhibits formation of ergosterol – the main component of the cell wall of fungi, preventing their further reproduction.

Squaleneepoxidase is not associated with P450 system.

The fungicidal effect is due to accumulation of squalenes in the fungal cell which extract lipid components from membranes.

The lipid granules accumulated inside the cell gradually increase in volume and break the damaged cytoplasmic membranes leading to the death of the fungal cell.

Terbinafine is highly active against all dermatophytes belonging to Trichophyton, Microsporum and Epidermophyton genera.

Terbinafine in low concentrations has fungicidal effect against dermatophytes (Trichophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum; Microsporum canis and Epidermophyton floccosum);

molds (Aspergillus spp, Scopulariopsis brevicaulis), yeasts – Candida albicans, C.stellatoidea, C.tropicalis, C.parapsilosis, C.guillermondi, C.kursei, C.pseudotropicalis, Pityrosporum orbiculare (P.ovale and Malassezia furfur); dimorphic fungi (Sporothrix schenckii and others).

The effect of terbinafine against yeast-like fungi, depending on their species, may be fungicidal (Candida parapsilosis) or fungistatic (Candida albicans).

Fungoterbin® also has anti-inflammatory, antipruritic and keratolytic effect. Due to the presence of urea in the cream, the drug has a moisturizing effect and promotes deeper penetration of terbinafine into the skin.

Pharmacokinetics

When applied topically the drug is only slightly absorbed (absorption – 5%); it is accumulated in skin, sebaceous glands, hair follicles, subcutaneous tissue and acts primarily in the application site.

Indications

Skin itching, Fungus, chickens, Prevention of fungal diseases, Skin fungus, Scalp fungusFungal skin diseases caused by sensitive pathogens (trichophytosis, microsporia, epidermophytosis, rubrophytosis, candidiasis of the skin):

• foot mycosis/”foot fungus” (tinea pedis);
• torso mycosis (tinea corporis), including mycosis of smooth skin and mycosis of large folds;
• superficial candidiasis of the skin caused by fungi of the genus Candida (such as Candida albicans);
• mottled lichen (pityriasis versicolor).

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Active ingredient

Terbinafine

Composition

100 g of cream contain:

The active ingredient:

Terbinafine hydrochloride (in terms of 100% dry matter) – 1.0 g;

Associates:

Butylhydroxytoluene (dibunol) – 0.1 g,

Urea (urea) – 0.50 g,

Macrogol cetostearate (Eumulgin® B 2) – 1.50 g,

How to take, the dosage

Externally.

Clean and dry affected areas before application.

Fungoterbin is applied 1 or 2 times a day to the affected skin and adjacent areas.

The cream is applied in a thin layer and lightly rubbed in.

When applied to the skin folds (inguinal area, interjugal area, under the breasts) it is recommended to put gauze strip / bandage.

Dermatomycosis of the trunk, large folds, feet, legs: once a day, treatment period – 1 week.

Dermatomycosis of feet: once a day, treatment duration – 1 week.

Skin Candida: once a day or twice a day, treatment duration – 1 – 2 weeks.

Lichen planus: once a day or twice a day, treatment duration – 1 week.

Interaction

Any interaction of Fungoterbin® cream with other drugs is not known.

Special Instructions

Avoid contact with the mucous membranes of the eyes, nose and mouth. In case of accidental contact with the eyes you should immediately rinse them with running water.

Restoration of healthy skin appearance is noted in the first days of treatment, which is not a sign of cure. It should be remembered that irregular use or premature termination of treatment increases the risk of relapse.

In the course of treatment it is necessary to observe general rules of hygiene to prevent reinfection (reinfection) through clothes and shoes. The absence of effect after 1 week of treatment requires a diagnosis.

Fungoterbin® does not disrupt the function of the skin and its sebaceous and sweat glands.

Fungoterbin® has a subtle odor and does not leave marks on clothing.

Effect on the ability to drive and operate machinery
No effect.

Contraindications

Hypersensitivity to terbinafine and / or other components of the drug.
With caution

Severe renal or hepatic failure, chronic alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, vascular occlusive disease of the extremities, pregnancy, lactation, children under 12 years (lack of sufficient experience in use).

Side effects

Fungoterbin is generally well tolerated.

Side effects are usually mild to moderate and transient.

When taken orally there may be:

Gastrointestinal tract: dyspepsia, abdominal pain, feeling of stomach fullness, nausea, loss of appetite, diarrhea; sometimes impaired taste sensation, including loss of taste (recovered after several weeks of discontinuing treatment);

Musculoskeletal system: Muscle pain, joint pain

Hematopoietic system: neutropenia, agranulocytosis, thrombocytopenia, rarely – lymphopenia.

Allergic reactions: skin rash in the form of spots, blisters, rarely – toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactoid reactions.

Overdose

When used externally is unlikely.

Symptoms: accidental ingestion of the cream may cause headache, nausea, gastralgia, dizziness, frequent urination, rash.

Treatment: activated carbon, if necessary – symptomatic and supportive therapy.

Pregnancy use

The experience of using the drug in pregnancy is limited, therefore Fungoterbin should not be used in pregnancy.

Terbinafine is excreted with the breast milk, so if it is necessary to prescribe the drug, it is necessary to consider stopping breastfeeding.

Similarities

Terbinafin-Teva, Exifin, Lamisil, Lamisil Dermgel, Terbisil, Binafin, Termicon, Exiter, Terbinafin, Terbix