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Modern possibilities of using terbinafine for the treatment of fungal diseases

The incidence rate increases significantly in patients in older age groups, regardless of gender. According to foreign researchers, onychomycosis affects from 2 to 18.5% of the total population of the planet, and in the age group of 70 years and older, 50% of the world’s population is affected by this disease [1,8]. According to various authors, fungal infections of the feet are observed in a third of all European residents [18,20]. As a rule, the development of onychomycosis is preceded by mycosis of the feet - according to our data, only 30% of patients had isolated onychomycosis, in the remaining 70% of patients it was combined with mycosis, which began before the fungal infection of the nails [2]. Thus, treatment of mycosis of the feet is the prevention of the development of onychomycosis. Very often, dermatologists are faced with insufficient awareness of patients - the latter do not know about the presence of a fungal infection, even seeing manifestations on the skin in the form of peeling, intertrigo, hyperkeratosis, and attribute this to physiological characteristics or age-related changes. On the other hand, some patients, seeing changes in the nail plates, regard this as onychomycosis and begin to treat it themselves with all available means. In the presence of mycosis of smooth skin without affecting the nails and involving the hair in the process, a cure can be achieved using only topical antimycotics. One of the most active antimycotics is terbinafine. It belongs to allylamine derivatives. In terms of the breadth of the spectrum of antifungal action, this drug surpasses all other antifungal drugs: polyene antibiotics, azoles (imidazole derivatives - clotrimazole, ketoconazole, etc., as well as first generation triazoles - itraconazole, fluconazole, etc.) and echinocandins. In recent years, many studies have been conducted confirming the high effectiveness and safety of terbinafine (Lamisil) in the treatment of fungal infections. The undoubted advantages of this drug include a large number of its forms for external use - cream, dermgel, spray and film-forming solution for the treatment of types of mycosis. Terbinafine in the form of a cream is ideal for squamous and squamous-hyperkeratotic forms. In the first case, it is enough to apply the cream to the affected area once a day. within 7 days [15]. For the treatment of hyperkeratotic forms of mycosis, use the drug 2 times a day. within 2 weeks. makes it possible to achieve clinical and mycological cure. In a study conducted by Yu.N. Perlamutrov and K.B. Olkhovskaya, it has been shown that complete mycological cure is achieved with the use of terbinafine 1 time per day. within 2 weeks. occurred in 80% of patients, and 2 times a day. – in 93%. At the same time, by the end of the course of treatment, the disappearance of peeling, itching and healing of deep and superficial cracks was observed in patients in both groups, but when using the cream 2 times a day. these symptoms resolved more quickly [4]. For intertriginous and dyshidrotic forms, it is appropriate to prescribe dermgel or spray - they have a pronounced antipruritic and drying effect. It is also convenient to prescribe the spray in the presence of lesions on smooth skin (lichen versicolor, microsporia) in the folds and on the scalp. So, according to A.A. Haldina et al., when applying both spray and dermgel to lesions in large folds, etiological cure was observed in 100% of cases, regardless of the nature of mycosis (Tr. rubrum, Ep. floccosum, C. albicans). When analyzing the dynamics of regression of skin symptoms, it was revealed that when using the spray, the regression of clinical symptoms is somewhat ahead of that when using dermgel, this is especially noticeable with the regression of itching and maceration [7]. There is a high effectiveness of using spray and dermgel for the treatment of patients with pityriasis versicolor. According to L.P. Kotrekhova et al., the effectiveness of dermgel and spray therapy was 94.8 and 93.8%, respectively. At the same time, patients note the ease of use and good organoleptic properties of the drug, such as the absence of greasiness and oily sheen of the skin. The hygroscopic properties of the drug made it possible to apply it to skin folds even in obese patients [3]. A new, and certainly promising form is a film-forming solution, which is applied to the skin of the feet once. N.N. Potekaev et al. treated 20 patients with various forms of mycosis of the feet with Lamisil Uno. Clinical and mycological cure occurred in 80% of patients by the 10th day of observation. The drug was ineffective in the squamous-hyperkeratotic form. For erased, squamous and intertriginous forms, the effectiveness is 100%. I would especially like to note that single use of the drug is very convenient for patients [5]. A randomized, double-blind, placebo-controlled study was conducted on the effectiveness of a single application of a 1% film-forming solution of terbinafine in 324 patients with mycosis of the feet. The result was assessed after 6 weeks. after using the drug. The study found negative culture, microscopy, and mycological cure rates of 91%, 81%, and 78%, respectively, while the placebo response rate was 17% [11]. Another very important point is the possibility of curing mycosis in a short time - with squamous and intertriginous forms of the lesion, the disease is cured in 1 week, while azole drugs must be used for 4 weeks. [17,18]. A longer course of therapy often leads to non-compliance with the treatment regimen; patients stop using the drug after visible improvements and are not treated further, which leads to relapse of the disease. In some cases (with damage to the nail plates, a common skin process, hair involvement), local antifungal therapy is not effective enough, and there is a need to prescribe a systemic drug, the most effective and safe of which is terbinafine [19]. Terbinafine has a fungicidal effect on dermatophytes, molds and some dimorphic fungi; on yeast fungi, depending on their type, it has a fungistatic or fungicidal effect [13,16]. The pronounced antimycotic effect of terbinafine also manifests itself in vivo, which is facilitated by its pharmacokinetics. After oral administration, the maximum concentration of terbinafine in the blood is reached within 2 hours, the drug is almost completely bound to plasma proteins. Due to its lipophilicity, terbinafine quickly diffuses through the dermis and accumulates in the stratum corneum and nail plates, and is also excreted with sebum, resulting in high concentrations of the drug in hair follicles and hair. Stable concentrations of terbinafine in tissues are achieved 10–14 days after the start of oral administration, the half-life of its elimination varies from 24 to 156 days, as a result of which the drug remains in the nail plates for a long time after stopping its use [8,10]. It is known that fungal infections of the scalp can be successfully treated with terbinafine. To confirm this, 3 groups of children aged 2 to 14 years with a confirmed diagnosis of trichophytosis were treated with griseofulvin for a month and terbinafine for 2 weeks. and 1 month It was shown that the effectiveness of therapy was approximately the same and amounted to 100% with griseofulvin, 95% with a 2-week course of terbinafine and 94.1% with a monthly dose [12]. A study was conducted on the effectiveness of oral terbinafine for the treatment of a hyperkeratotic form of mycosis of the feet with a torpid course. The drug at a dose of 125 mg was prescribed daily for 1 month. It was found that the maximum concentration of the drug (247.8 ng) in the stratum corneum of the epidermis was determined by the end of 1 week. treatment, which is 50 times the minimum inhibitory concentration for dermatophytes. After 6 weeks the concentration of the drug decreased to 50.73 ng, and after 8 weeks. terbinafine was no longer detectable in the skin. The effectiveness of therapy was 95% [14]. The low potential for drug interactions with other drugs is also important, because Onychomycosis often affects older people who are forced to take a large number of different medications for other diseases [13]. Thus, based on the analysis of literature data, we can conclude that terbinafine (Lamisil) is a highly effective drug for the treatment of fungal infections, has a large number of different forms, which significantly expand the possibilities of antifungal therapy. Literature 1. Malcolm B. Athlete's foot // Attending physician. 1998. No. 6. 2. Vasenova V.Yu. Immunopathogenesis, morphofunctional characteristics, clinical picture, complex therapy and prevention of onychomycosis: Abstract of thesis. ... doc. honey. Sci. M., 2008. 3. Kotrekhova L.P., Vasilyeva N.V., Raznatovsky K.I., Piotrovskaya I.V. Clinical efficacy and safety of terbinafine (Lamisil spray, Lamisil dermgel) in the treatment of pityriasis versicolor // Clinical dermatology and venereology. 2007. No. 3. P. 35–38. 4. Perlamutrov Yu.N., Olkhovskaya K.B. Optimization of therapy for mycoses of the feet in women using 1% Lamisil cream // Clinical dermatology and venereology. 2006. No. 2. P. 78–80. 5. Potekaev N.N., Serov D.G., Dvoryankova E.V., Zhukovsky R.O. Effective therapy of mycoses of the feet with a single use of a new external form of terbinafine - a film-forming solution of Lamisil Uno // Clinical Dermatology and Venereology. 2008. No. 4. pp. 85–88. 6. Sergeev A.Yu., Ivanov O.L., Sergeev A.Yu. and others. Study of modern epidemiology of onychomycosis // Bulletin of Dermatology and Venereology. 2002. No. 3. P. 31–35. 7. Khaldin A.A., Tsykin A.A., Izyumova I.M. Clinical and etiological effectiveness of 1% Lamisil® spray in the treatment of fungal infections of large skin folds // Russian Journal of Skin and Venereal Diseases. 2007. No. 1. P. 56. 8. Baran R. Onychomycosis: the current approach to diagnosis and therapy. London: Malden MA, 1999. 9. Chen SCA, Sorrell TC New Drugs, Old Drugs. Antifungal agents // Med. J. Austral. 2007. Vol. 187. No. 7. R. 404–409. 10. Cribier BJ, Bakshi R. Terbinafin in the treatment of onychomycosis: a review of its efficacy in high-risk populations and in patients with nondermatophyte infections // BJ Dermatol. 2004. Vol.150. R. 414–420. 11. De Chauvin MF, Viguie-Vallanet C., Kienzler JL, Larnier C. Novel, single-dose, topical treatment of tinea pedis using terbinafine: results of a dose-finding clinical trial. Mycoses. 2008 Jan. Vol. 51(1). R. 1–6. 12. Deng S., Hu H., Abliz P., Wan Z., Wang A., Cheng W., Li R. A random comparative study of terbinafine versus griseofulvin in patients with tinea capitis in Western China. Mycopathologia. 2011 Nov. Vol. 172(5). R. 365–372. 13. Gianni C. Update on antifungal therapy with terbinafine // G Ital Dermatol Venereol. 2010 Jun. Vol. 145(3). R. 415–424. 14. Kikuchi I., Tanuma H., Morimoto K., Kawana S. Usefulness and pharmacokinetic study of oral terbinafine for hyperkeratotic-type tinea pedis // Mycoses. 2008 Nov. Vol. 51(6). R. 523–531. 15. Korting HC, Kiencke P., Nelles S., Rychlik R. Comparable efficacy and safety of various topical formulations of terbinafine in tinea pedis irrespective of the treatment regimen: results of a meta-analysis // Am J Clin Dermatol. 2007. Vol. 8 (6). R. 357–364. 16. Revankar SG, Nailor MD, Sobel JD Use of terbinafine in rare and refractory mycoses // Future Microbiol. 2008 Feb. Vol. 3(1). R. 9–17. 17. Schafer–Korting M., Schoellmann C., Korting HC Fungicidal activity plus reservoir effect allow short treatment courses with terbinafine in tinea pedis // Skin Pharmacol Physiol. 2008. Vol. 21(4). R. 203–210. 18. Schmid–Wendtner MH, Korting H. Topical terbinafine. Reduction of duration of therapy for tinea pedis // Hautarzt. 2008 Dec. Vol. 59 (12). R. 986–991. 19. Singal A., Khanna D. Onychomycosis: Diagnosis and management // Indian J Dermatol Venereol Leprol. 2011 Nov–Dec. Vol. 77(6). R. 659–672. 20. Stock I. Antimycotic therapy of Tinea pedis and other foot mycoses // Med Monatsschr Pharm. 2008 Jul. Vol. 31(7). R. 247–258. Van Duyn Graham L., Elewski BE. Recent updates in oral terbinafine: its use in onychomycosis and tinea capitis in the US // Mycoses. 2011 Nov. Vol. 54 (6). R. 679–685.

Overdose

If an overdose of Terbinafine in tablet form occurs, the patient may experience a rash , nausea , headache , vomiting , dizziness , epigastric pain, and frequent urination. It is important to perform gastric lavage; they also practice taking activated carbon and symptomatic treatment.

There is no data on an overdose of the drug in the form of external agents. If accidentally ingested as an ointment or cream, nausea, headache, dizziness, and epigastric pain may occur. In this case, symptomatic treatment is carried out; the use of activated carbon is indicated.

Side effects

When taking pills, patients may experience the following side effects:

feeling of pain and weakness in the epigastric region;
loss of appetite;
cholestasis;
taste disturbance;
allergic reactions;
nausea;
diarrhea;
decreased levels of platelets and neutrophils in the blood.

When applied topically, itching, burning and hyperemia may occur in the areas where the product was applied. Allergic manifestations may develop in rare cases.

Contraindications

The use of medication in tablet form is contraindicated for the following diseases and conditions:

liver disease in chronic or active form;
chronic renal failure (creatinine clearance less than 50 ml/min);
the patient’s age is up to three years and his weight is up to 20 kg;
lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
lactation;
high sensitivity to the components of the product.

Caution Terbinafine tablets should be prescribed to people with chronic renal failure (with glomerular filtration more than 50 ml/min based on the Rehberg test), hematopoietic disorders, alcoholism , endocrine diseases, psoriasis , vasoconstriction of the extremities, tumors, systemic and cutaneous lupus erythematosus.

When taking Terbinafine, the condition of the liver and kidneys should be closely monitored. Terbinafine or Terbinafine Teva tablets should be discontinued immediately if the following symptoms occur:

abdominal pain;
nausea;
loss of appetite;
jaundice;
weakness;
darkening of urine;
light cal.

Forms of the drug for topical use should not be used in case of hypersensitivity or allergies.

Relative contraindications to the use of such drugs are:

tumors;
alcoholism;
liver and kidney failure;
endocrine diseases;
narrowing of the lumen of blood vessels;
hematopoietic disorder;
The patient's age is up to 12 years.

Compound

Terbinafine tablets contain the active substance terbinafine hydrochloride , as well as additional components: MCC, lactose monohydrate, potato starch, talc, primellose, aerosil, magnesium stearate.
Terbinafine cream contains the active component terbinafine hydrochloride , as well as additional components: benzyl alcohol, stearic acid, distilled glycerol, petrolatum, emulsifier, water, triethanolamine.

The ointment contains the active component terbinafine hydrochloride , as well as additional components: methyl parahydroxybenzoate, carbomer , petroleum jelly, polysorbate, sodium hydroxide, propylene glycol, water.

Terbinafine spray contains the active component terbinafine hydrochloride , as well as additional components: macrogol 400 , water, propylene glycol, ethyl alcohol.

pharmachologic effect

Terbinafine is a fungicidal, antifungal drug. Demonstrates activity against almost all types of fungi that can infect the human body. In small concentrations it exhibits a fungicidal effect against molds, dermatophytes, and some types of dimorphic fungi. Both fungicidal and fungistatic effects are possible on yeast fungi.

Its therapeutic effect is determined by its destructive effect on the fungal cell membrane, as well as due to the specific inhibition of squalene epoxidase (an enzyme important for the normal function of the fungal cell membrane).

Under the influence of Terbinafine, the production of ergosterol , due to the lack of which the amount of squalene in the fungal cell increases. As a result, all enzyme systems are inactivated, and the cell dies.

The active component does not affect the cytochrome P450 system, therefore, does not affect the metabolism of hormones or other drugs.