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Lamisil

Lamisil
Lamisil is prescribed for onychomycosis caused by fungi dermatophytes, mycoses of the scalp, fungal infections of the skin - treatment of dermatomycosis of the trunk, legs, feet, as well as yeast infections of the skin caused by fungi of the genus Candida - in cases where the localization, severity or prevalence of the infection determine the appropriateness oral therapy. Unlike lek. topical forms of oral terbinafine are not effective in versicolor versicolor.

Brand: Terbinafine

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: April 2024
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Lamisil 250 mg
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Product description

Pharmacological action of the drug Lamisil

Buy Lamisil in Canada

Terbinafine is an allylamine that has a broad spectrum of action against fungal infections of the skin, hair and nails caused by dermatophytes such as Trichophyton (for example: T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum (for example Microsporum canis), Epidermophyton floccosum and yeasts of the genus Candida (for example Candida albicans) and Pityrosporum. In low concentrations, terbinafine has a fungicidal effect against dermatophytes, molds and some dimorphic fungi. Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically inhibits the early stage of sterol biosynthesis in the fungal cell. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell. Terbinafine works by inhibiting the enzyme squalene epoxidase in the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450 system.

When administered orally, the drug accumulates in the skin, hair and nails in concentrations that provide a fungicidal effect.

Pharmacokinetics

After oral administration, terbinafine is well absorbed (> 70%), and the absolute bioavailability of terbinafine, taking into account the metabolism after the first passage through the liver, is approximately 50%. A single oral dose of 250 mg terbinafine showed an average maximum plasma concentration of 1.3 μg / ml 1.5 hours after ingestion.

At steady-state, compared with a single dose, the maximum concentration of terbinafine was on average 25% higher, and the exposure (AUC) in plasma increased 2.3 times. Based on the increase in plasma exposure, an effective half-life of ~ 30 hours can be calculated. Food intake has little effect on the bioavailability of terbinafine (an increase in the area under the curve by approximately 20%), which does not require dose adjustment.

Terbinafine actively binds to plasma proteins (99%). It diffuses rapidly through the dermis and concentrates in the lipophilic stratum corneum. Terbinafine is also excreted in the secretions of the sebaceous glands and reaches high concentrations in the hair follicles, hair and skin. It has been proven that terbinafine penetrates the nail plate in the first few weeks after starting therapy.

Terbinafine is rapidly metabolized with the participation of at least seven isoenzymes of cytochrome P450, with the main role played by isoenzymes CYP2C9, CYP1A2, CYP3A4, CYP2C8, CYP2C19. Due to the biotransformation of terbinafine, metabolites are formed that do not have antifungal activity. They are excreted mainly in the urine. There were no clinically significant changes in the equilibrium plasma concentration of terbinafine depending on age.

Pharmacokinetic studies of a single dose in patients with kidney disease (creatinine clearance <50 ml / min) or with concomitant liver disease have shown that Lamisil clearance can be reduced by about 50%.

Indications for use

Lamisil for the treatment of fungus

• Onychomycosis (fungal infection of the nails).

• Mycoses of the scalp caused by dermatophytes such as Trichophyton (eg T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum canis and Epidermophyton floccosum.

• severe infections caused by dermatophytes (treatment of trichophytosis of smooth skin, perineum, dermatophytosis of the feet and dermatomycosis of the scalp) and yeast infections of the skin caused by fungi of the genus Candida (eg Candida albicans), in cases where the localization of the lesion, the severity and prevalence of the infection determine appropriateness of oral therapy.

Method of administration and dosage of the drug Lamisil

Lamisil drug appearance

The drug is taken orally with water. The duration of treatment depends on the nature and severity of the disease.

The required duration of therapy should be accurately established, since insufficient duration of treatment and / or irregular use of the drug can lead to a relapse of the infection.

Adults

250 mg once a day.

Adolescents weighing more than 40 kg (usually> 12 years of age): 250 mg (1 tablet) once a day.

Children weighing 20-40 kg (5-12 years): 125 mg ('A tablets) 1 time per day.

Children weighing <20 kg: data from controlled studies in this age group of patients are very limited, and therefore the drug should be used only in the absence of a therapeutic alternative and in the case when the potential benefit from the use of the drug outweighs the possible risks.

There are no data on the use of the drug in children under 2 years of age, and therefore it is not recommended to use it in this age group of patients.

The drug is taken orally with water. The duration of treatment depends on the nature and severity of the disease.

The required duration of therapy should be accurately established, since insufficient duration of treatment and / or irregular use of the drug can lead to a relapse of the infection.

Overdose

Several cases of overdose are known (oral administration of up to 5 g of Lamisil). At the same time, headache, nausea, epigastric pain and dizziness were noted. Treatment that is recommended in case of overdose includes elimination of the drug, primarily with activated charcoal and, if necessary, the use of symptomatic therapy.

Interaction with other drugs

The effect of other drugs on terbinafine

Plasma clearance of terbinafine can be increased by drugs that induce metabolism, and can be reduced by drugs that inhibit cytochrome P450. If necessary, concomitant treatment with such drugs, the dosage of Lamisil must be adjusted.

Medicines that can enhance the effect of terbinafine or increase its plasma concentration

Cimetidine reduces the clearance of terbinafine by 33%.

Fluconazole increases the Cmax and AUC of terbinafine by 52% and 69%, respectively, due to inhibition of the CYP2C9 and CYP3A4 enzymes. A similar increase in exposure may occur if other drugs that simultaneously inhibit CYP2C9 and CYP3A4, such as ketoconazole and amiodarone, are co-administered with terbinafine.

Medicines that can reduce the effect of terbinafine or reduce its plasma concentration Rifampicin accelerates the clearance of terbinafine by 100%.

Effect of terbinafine on other medicinal products

The results of studies conducted in vitro and on healthy volunteers show that terbinafine has little potential to suppress or enhance the clearance of drugs metabolized by the cytochrome P450 system (for example: terfenadine, triazolam, tolbutamide or oral contraceptives), except for those drugs that are metabolized by CYP2D6. Terbinafine does not affect the clearance of antipyrine or digoxin.

Terbinafine has no effect on the pharmacokinetics of fluconazole. There were also no clinically significant interactions between terbinafine and co-trimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline.

In patients who simultaneously took Lamisil and oral contraceptives, in some cases, irregularity of the menstrual cycle was noted, although the frequency of these violations remained within the range observed with the isolated use of oral contraceptives.

Terbinafine can enhance the effect or increase the plasma concentration of the following drugs: Caffeine - terbinafine reduces the clearance of caffeine, which is administered intravenously, by 19%.

Drugs predominantly metabolized by CYP2D6

In in vitro and in vivo studies, terbinafine has been found to inhibit CYP2D6-mediated metabolism. These findings may be clinically relevant for drugs metabolized by this enzyme, such as tricyclic antidepressants (TCAs), beta blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics (including class 1A, 1B, and 1C), and type B MAO inhibitors. , especially if such a drug has a small range of therapeutic concentration.

Terbinafine reduces the clearance of desipramine by 82%.

In studies in healthy people - rapid metabolizers of dextromethorphan (an antitussive drug and a marker substrate CYP2D6), terbinafine increases the metabolic rate of dextromethorphan / dextrorphan in urine by an average of 16 to 97 times. Thus, terbinafine can convert rapid metabolizers of CYP2D6 to slow ones.

Precautions

Liver function.

Lamisil is not recommended for patients with chronic or active liver damage. Before the appointment of Lamisil, it is necessary to carry out functional tests of the liver, because hepatotoxicity can occur in patients with and without existing liver disease. Therefore, periodic monitoring (after 4-6 weeks of treatment) of liver function tests is recommended. Taking Lamisil should be discontinued immediately if liver function tests increase.

In very rare cases, patients receiving Lamisil tablets experienced severe hepatic impairment (in some cases, fatal or the need for liver transplantation). In most cases of liver failure, patients already had severe liver dysfunction, and there was no definite causal relationship with the use of Lamisil tablets. Patients taking Lamisil tablets should be warned to inform their doctor immediately about any signs of unexplained persistent nausea, decreased appetite, fatigue, vomiting, pain in the right upper abdomen, jaundice, dark urine or light stools. Patients with these symptoms should stop taking Lamisil and their liver function should be tested immediately.

Dermatological reactions.

In very rare cases, patients taking Lamisil tablets have experienced serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms). In the event of progressive skin rashes, treatment with Lamisil should be discontinued.

Caution is required when using terbinafine in patients with psoriasis or lupus erythematosus, since there have been post-marketing reports of the onset and exacerbation of psoriasis, cutaneous and systemic lupus erythematosus.

Hematological reactions.

In patients taking Lamisil tablets, very rare cases of pathological changes in the blood (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported. In case of any pathological change in blood in patients taking Lamisil, a possible change in drug treatment should be recommended, including discontinuation of Lamisil.

Kidney function.

In patients with reduced renal function (creatinine clearance less than 50 ml / min or serum creatinine levels exceeding 300 μmol / l), the use of Lamisil has not been sufficiently studied, therefore it is not recommended for such patients to use Lamisil.

In in vitro and in vivo studies, terbinafine has been found to inhibit the metabolism mediated by the CYP2D6 enzyme. This is of clinical importance for drugs that are predominantly metabolized by CYP2D6, especially if they have a narrow therapeutic window, for example, some drugs from the following classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, MAO type B inhibitors, antiarrhythmics (including class 1A, 1B and 1C), as well as beta-receptor blockers.

Note. Unlike Lamisil for topical use, Lamisil for oral administration is not indicated for the treatment of varicolored lichen or vaginal candidiasis.


Side effects

Sideare presented according to the MedDRA classification. When assessing the frequency of occurrence of various adverse reactions, the following classification was used: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rare (<1/10000), including single messages; post-marketing spontaneous messages - frequency unknown.

From the blood and lymphatic system: infrequently - anemia; very rarely - neutropenia, agranulocytosis, thrombocytopenia,pashdarning.

From the immune system: very rarely - anaphylactoid reactions (including angioedema), cutaneous and systemic lupus erythematosus; frequency unknown - anaphylactic reactions, reactions such as serum sickness.

Mental disorders: often - depression; infrequently - anxiety.

From the nervous system: very often - headache; often - dysgesia (a violation of the sense of taste), including loss of taste, usually disappears within a few weeks after stopping the use of the drug. Isolated cases of prolonged decrease in taste have been reported; infrequently - paresthesia and hypesthesia; frequency unknown - anosmia, including permanent anosmia, hyposmia.

From the side of the organ of vision: often - weakening of vision; frequency unknown - reduced visual acuity.

On the part of the hearing organs and the labyrinth: infrequently - tinnitus; frequency unknown - hypoacusia, hearing impairment.

From the side of the cardiovascular system: the frequency is unknown - vasculitis.

From the gastrointestinal tract: very often - a feeling of fullness in the stomach, decreased appetite, indigestion, nausea, mild abdominal pain, diarrhea; frequency unknown - pancreatitis.

From the hepatobiliary system: rarely - rarely - liver dysfunction, hepatitis, jaundice, cholestasis, increased liver enzymes (see "Precautions").

On the part of the skin and subcutaneous tissues: very often - rash, urticaria; infrequently - photosensitivity reactions; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic rash, exfoliative dermatitis, bullous dermatitis, psoriasis-like rashes or exacerbation of psoriasis, hair loss. Frequency unknown — drug rash with eosinophilia and systemic symptoms.

From the musculoskeletal system: very often - arthralgia, myalgia; frequency unknown - rhabdomyolysis.

General disorders: often - fatigue; infrequently - fever; frequency unknown - illness with flu-like symptoms.

Research: infrequently - weight loss due to dysgesion; the frequency is unknown - an increase in the level of creatine phosphokinase.