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

Fungal skin diseases caused by sensitive pathogens (trichophytosis, microsporia, epidermophytosis, rubrophytosis, skin candidiasis):
mycosis of the feet / “foot fungus” (tinea pedis);
mycosis of the trunk (tinea corporis), including mycosis of smooth skin and mycosis of large folds;
Athlete’s foot (tinea craris),
superficial skin candidiasis caused by fungi of the genus Candida (for example, Candida albicans);
pityriasis versicolor (pityriasis versicolor).

Pharmacological effect

Pharmacodynamics

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

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

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

By inhibiting the enzyme squalene epoxidase, terbinafine inhibits the formation of ergosterol, the main component of the cell wall of fungi, preventing their further reproduction.

Squalene epoxidase is not associated with the P450 system.

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

Lipid granules accumulating inside the cell, gradually increasing in volume, rupture the defective cytoplasmic membranes, leading the fungal cell to death.

Terbinafine is highly active against all dermatophytes grouped into the genera Trichophyton, Microsporum and Epidermophyton.

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

molds (Aspergillus spp., Scopulariopsis brevicaulis), yeast-like – 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, etc.).

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

Fungoterbin® also has anti-inflammatory, antipruritic, and keratolytic effects. 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 externally, the drug is absorbed very slightly (absorption – 5%); accumulates in the skin, sebaceous glands, hair follicles, subcutaneous tissue and exerts its effect mainly at the site of application.

Special instructions

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

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

During the treatment process, it is necessary to follow general hygiene rules to prevent reinfection (re-infection) through underwear and shoes. Lack of effect after 1 week of treatment requires clarification of the diagnosis.

Fungoterbin® does not interfere with the function of the skin and the functioning of its sebaceous and sweat glands.

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

Impact on the ability to drive vehicles and operate machinery
No effect.

Active ingredient

Terbinafine

Composition

100 g of cream contains:

Active substance:

Terbinafine hydrochloride (based on 100% dry matter) – 1.0 g;

Excipients:

Butylated hydroxytoluene (dibunol) – 0.1 g,

Urea (carbamide) – 0.50 g,

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

Cetostearyl alcohol [cetyl alcohol not more than 60%,

Stearyl alcohol not less than 40%] (Lanette® O) – 4.70 g,

Poloxamer (emuxol-268, lutrol F 68) – 0.75 g, imidomourea (Germall) – 0.20 g,

Propylene glycol – 23.00 g,

Liquid paraffin (medical vaseline oil) – 35.00 g,

Vaseline – 7.00 g, water (purified water) – up to 100 g.

Pregnancy

Experience with the use of the drug during pregnancy is limited, so Fungoterbine should not be used during pregnancy.

Terbinafine is excreted in breast milk, so if it is necessary to prescribe the drug, it is necessary to decide on stopping breastfeeding.

Contraindications

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

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

Side Effects

Fungoterbine is generally well tolerated.

Side effects are usually mild or moderate and are transient.

When taken orally, the following may occur:

From the gastrointestinal tract: dyspepsia, abdominal pain, feeling of fullness, nausea, loss of appetite, diarrhea; sometimes a disturbance in taste, including loss of taste (recovers a few weeks after stopping treatment);

From the musculoskeletal system: muscle pain, joint pain

From the 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.

Interaction

There are no known interactions of Fungoterbin® cream with other medications.

Overdose

When used externally, it is unlikely.

Symptoms: if the cream is accidentally ingested, headache, nausea, gastralgia, dizziness, frequent urination, and rash are possible.

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

Storage conditions

Store at temperatures between 10 and 25°C.

Keep out of the reach of children.

Shelf life

2 years

Manufacturer

Nizhpharm JSC, Russia