Fungoterbin Neo, cream 10 mg/g+100 mg/g 15 g

Terbinafine, the active ingredient of Fungoterbine® NEO, is an allylamine and has a broad spectrum of antifungal action.

Terbinafine disrupts the early stages of ergosterol biosynthesis occurring in fungi.

This leads to ergosterol deficiency and to intracellular accumulation of squalene, which causes cell death of the fungus.

The action of terbinafine is by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.

This enzyme is not part of the cytochrome P450 system, so terbinafine has no effect on the metabolism of hormones or other drugs.

Terbinafine has fungicidal action against dermatophytes, molds and some dimorphic fungi.

The activity against yeast-like fungi, depending on their species, may be fungicidal or fungistatic.

Urea, the second active ingredient in Fungoterbin® NEO, has a soothing, exfoliating and moisturizing effect and can increase dermatopenetrance (penetration into the skin) and create high concentrations of terbinafine in the skin.

The urea helps to bind water and soften the stratum corneum of the skin.

Pharmacokinetics

Less than 5% of the dose is absorbed when the cream is applied topically, so there is minimal systemic action.

On a single application on a 30 cm2 skin surface, 3.5% of the dose is detectable in the urine.

The drug quickly penetrates the skin and accumulates in the sebaceous glands.

Indications

Treatment and prevention of fungal diseases: y

Fungal skin infections caused by dermatophytes such as Trychophyton (for example, T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum), Microsporum canis and Epidermophyton floccosum.

Infections of the skin caused by yeast-like fungi of the genus Candida (e.g. Candida albicans).

Multiple lichen (Pityrosporum versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Active ingredient

Composition

1 g of cream contains:

Active substances:

Terbinafine hydrochloride in terms of 100% substance – 0.01 g,

Urea – 0.10 g;

Auxiliary substances:

Butylhydroxytoluene (dibunol),

Macrogol cetostearate (Eumulgin® B 2),

Ceto stearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%],

Poloxamer (emuxol-268),

Imidourea (GermallÒ),

Propylene glycol,

Liquid paraffin (Vaseline medical oil),

Purified water – up to 1 g.

How to take, the dosage

The product is applied to the skin once or twice a day.

The affected areas should be cleaned and dried before applying the cream.

The cream is applied in a thin layer to the affected skin and rubbed in gently.

The application of an occlusive dressing may improve the effectiveness of the treatment.

Infections accompanied by diaper rash (under the breasts, between the fingers, between the buttocks and the groin), the spots where the cream is applied can be covered with gauze, especially at night.

The average duration of treatment:

Dermatomycosis of the trunk, shins: 1 week once daily.

Dermatomycosis of the feet: 1 week once a day.

Skin candida: 1 or 2 times a day for 1-2 weeks.

Mixed Lichen: 1 or 2 times a day for 2 weeks.

Special Instructions

A reduction in clinical manifestations is usually seen in the first days of treatment.

If treatment is intermittent or discontinued prematurely, there is a risk of recurrence of the infection.

If there is no sign of improvement after 1-2 weeks of therapy, the diagnosis must be verified.

The cream is for external use only.

Contact with the mucous membranes of the eyes, nose and mouth should be avoided.

If the product comes into contact with the mucosa, rinse with water and consult a doctor if necessary.

Synopsis

Features

Contraindications

Hypersensitivity to the components of the drug, children (under 2 years).

With caution

Hepatic and/or renal failure, alcoholism, blood diseases, tumors, metabolic diseases, vascular disease of the extremities.

Side effects

In rare cases, redness, itching or burning sensations have been reported where the cream was applied, but these phenomena have rarely made it necessary to stop treatment.

The above symptoms should be differentiated from allergic reactions, such as urticaria, which are rare, but if they do occur, treatment should be discontinued.

Overdose

No cases of overdose of the drug have been reported.

In case of accidental ingestion, the same side effects as in case of overdose of Fungoterbin® tablets can be expected, including: headache, nausea, dizziness, gastralgia, rapid urination, rash.

Treatment:

Active charcoal, symptomatic therapy if necessary.

The phenomena of urea overdose in external use are not known.