Terbinafin-KV (terbinafine) tablets 0.25 g. №14

Description

Terbinafin-KV (terbinafine) tablets 0.25 g. №14

Composition

active substance: terbinafine;

1 tablet contains terbinafine (in the form of hydrochloride) 250 mg;

Excipients: microcrystalline cellulose, corn starch, colloidal anhydrous silica, hypromellose, talc, magnesium stearate.

Dosage form

Tablets.

Main physical and chemical properties: round flat tablets from white to yellowish-white color.

Pharmacotherapeutic group

Antifungal drugs for use in dermatology. Antifungal drugs for systemic use. Terbinafine.
ATX code D01B A02.

Pharmacological properties

Terbinafine is an allylamine that has a broad spectrum of antifungal activity against skin, hair and nail infections caused by dermatophytes such as Trichophyton (eg, T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum ( for example Microsporum canis), Epidermophyton floccosum, and yeast fungi of the genus Candida (eg Candida albicans) and Pityrosporum. At low concentrations, terbinafine has a fungicidal effect on dermatophytes, molds and some dimorphic fungi. Depending on their species, the activity against yeast fungi can be fungicidal or fungistatic.

Indication:

Fungal infections of the skin and nails caused by Trichophyton (eg, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum:

• ringworm (trichophytia of smooth skin, trichophytia of the perineum and dermatophytia of the feet), when the location of the lesion, the severity or prevalence of infection determine the appropriateness of oral therapy;
• onychomycosis.

Contraindication

Hypersensitivity to the active substance and / or to other components of the medicinal product.
Acute or chronic liver disease.

Method of application and dosage

The drug is intended for oral use. The tablets should be swallowed with water, preferably at the same time of day, regardless of food intake.

The drug is used in a dose of 250 mg (1 tablet) once a day.

If the next dose is missed, the next dose should be taken as soon as possible. However, due to the pharmacokinetic properties of terbinafine, the missed dose should not be taken if the interval between the missed dose and the next dose is less than 4 hours.

The duration of treatment depends on the nature and severity of the disease. Care should be taken to ensure that treatment is carried out within an appropriate period of time. Improper duration of treatment and / or irregular use of the drug may lead to recurrence of the infection. Personal hygiene rules should be followed to prevent reinfection (from underwear, socks, shoes).

Recommended duration of treatment:

• dermatophytosis of the feet (interdigital, plantar / moccasin type) – 2-6 weeks;
• trichophytia of smooth skin – 4 weeks;
• perineal trichophytia – 2-4 weeks;
• cutaneous candidiasis – 2-4 weeks;
• trichophytia of the scalp – 4 weeks;
• onychomycosis caused by dermatophytes – 6-12 weeks (longer treatment may be required for patients with slow nail growth);
• nail infections – in most cases, 6 weeks is enough;
• toe infections – in most cases 12 weeks is enough.

In the case of fungal nail infections, the clinical effect usually occurs a few months after treatment. This is due to the regrowth of a healthy nail.

Children

There are limited data from the use of oral terbinafine in children, therefore the use of the drug is not recommended for this age group of patients.

Overdose

Several cases of overdose are known (oral administration of up to 5 g of terbinafine). Headache, nausea, epigastric pain and dizziness were noted. Treatment recommended in case of overdose includes removal of terbinafine, primarily with adsorbents and, if necessary, symptomatic maintenance therapy.

Side effects:

• From the metabolism and nutrition: loss of appetite;
  Severe isolated cases of decreased food intake have been reported, leading to significant weight loss.
• From the psyche: depression;
• From the nervous system: headache, dizziness, dysgeusia up to loss of taste;
• From the eyes: visual impairment;
• From the digestive tract: a feeling of fullness, dyspepsia, nausea, moderate abdominal pain, diarrhea;
• From the skin and subcutaneous tissue: rash, urticaria;
• From the musculoskeletal system and connective tissue: arthralgia, myalgia;
• From the body as a whole: exhaustion.