Lamisil cream 1% 30g

Active ingredient and dosage form

Lamisil pills : 1 pill contains terbinafine (in the form of hydrochloride) 250 mg;
Excipients: Magnesium stearate, anhydrous colloidal silicon dioxide, methylhydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch;
7, 14 pcs. in a blister, 1 or 2 blisters in a carton box.

Lamisil cream for external use 1% white, homogeneous, with a slight specific smell.
1 g of cream contains Terbinafine hydrochloride 10 mg;
Excipients: benzyl alcohol, sodium hydroxide, sorbitan stearate, cetyl palmitate, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, purified water;
15 g in a tube, 1 tube in a carton box.

Lamisil solution for external use 1%:
1 g of solution contains terbinafine hydrochloride 10 mg;
30 ml in plastic bottles, 1 bottle in a carton box.

Lamisil spray for external use 1% in the form of a transparent or light yellow liquid.
1 g of solution contains terbinafine hydrochloride 10 mg;
Excipients: macrogol cetostearyl ether, ethanol, purified water, propylene glycol, nitrogen.
15 or 30 ml in polypropylene bottles with a sprayer, 1 bottle in a carton box.

Lamisil dermgel gel for external use 1%:
1 g of gel contains terbinafine hydrochloride 10 mg;
Excipients: benzyl alcohol, sodium hydroxide, sorbitan monolaurate, polysorbate 20, isopropyl myristate, carbomer 974P, bottled hydroxytoluene, ethanol, demineralized water;
5, 15 or 30 g in tubes, 1 tube in a carton box.

Mechanism of action

Lamisil is an antifungal medication.
Terbinafine is an allylamine, which has a wide spectrum of action against fungi that cause diseases of the skin, hair and nails, including dermatophytes, such as Trichophyton (e.g., Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton tonsurans, Trichophyton violaceum), Microsporum (e.g., Microsporum canis), Epidermophyton floccosum, and yeasts Candida genus (e.g., 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 species, can be fungicidal or fungistatic.
Terbinafine specifically inhibits the early stage of sterol biosynthesis in the cell of the fungus. This leads to a deficiency of ergosterol and to the intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase in the cell membrane of the fungus. This enzyme does not belong to the cytochrome P system.₄₅₀. Terbinafine does not affect the metabolism of hormones or other drugs.
With the appointment of Lamisil inside the skin, hair and nails are concentrations of the drug, providing a fungicidal effect.

Indications and usage

Prevention and treatment of fungal infections of the skin:
- mycoses (fungal infection of the nails and scalp), inguinal athlete (tinea craris), fungal lesions of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;
- yeast infections of the skin, mainly those caused by the Candida genus (for example, Candida albicans), in particular diaper rash;
- versicolor versicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur) - Lamisil for topical use

Dosage and administration

Pills. The duration of treatment depends on the indication and the severity of the disease.
Children (aged 2 years and older): with a body weight of up to 20 kg, 62.5 mg once a day; with a body weight of 20-40 kg - 125 mg once a day; with body weight over 40 kg - 250 mg once a day.
For adults appoint 250 mg 1 time per day.
Data on the use of the drug in children under 2 years old (whose body weight is usually less than 12 kg) is not available.

Recommended duration of treatment with ringworm (interdigital, plantar, or sock type) - 2-6 weeks; with ringworm of the trunk, lower legs 2-4 weeks; at skin candidiasis - 2-4 weeks.
The complete disappearance of the manifestations of infection and complaints associated with it, can occur only a few weeks after mycological cure.
Recommended duration of treatment with mycosis of the scalp - 4 weeks. Mycoses of the scalp are observed mainly in children.
With onychomycosis the duration of effective treatment is in most patients from 6 to 12 weeks. With onychomycosis of the hands, in most cases 6 weeks of treatment is sufficient.With onychomycosis, in most cases, 12 weeks of treatment is sufficient. Some patients who have a reduced growth rate of nails may need longer treatment. The optimal clinical effect is observed several months after mycological cure and cessation of therapy. This is determined by the period of time that is necessary for the growth of a healthy nail.

There is no reason to assume that for the elderly it is required to change the dosage of the drug or that they have side effects that differ from those of younger patients.
In the case of use in this age group of the drug in pills should consider the possibility of concomitant abnormal liver function or kidney.

Determined thatin children over 2 years old Lamisil tolerance for oral administration is good.

Outwardly
LAMIZIL and LAMIZIL DERMGEL can be applied 1 or 2 times / day, depending on the evidence.
Before using the drug, it is necessary to thoroughly clean and dry the affected areas.
The drug is sprayed (spray) or applied (solution) to the affected areas in an amount sufficient to thoroughly moisturize it, and, in addition, applied to the adjacent areas of both the affected and intact skin.
The cream is applied with a thin layer on the affected skin and surrounding areas and lightly rubbed.
In case of infections with diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the inguinal region) the place of application of the cream can be covered with gauze, especially at night.
With extensive fungal infections of the body It is recommended to apply a spray in a 30 ml bottle or cream in tubes of 30 g each.
The average duration of treatment and frequency of use of the drug with ringworm of the trunk, lower legs is 1 week 1 time / day; with ringworm - 1 week 1 time / day; with multi-colored lichen - 2 weeks 1-2 times / day; with candidiasis of the skin 1-2 weeks 1-2 times / day.

Reducing the severity of clinical manifestations is usually observed in the first days of treatment. In the case of irregular treatment or its premature termination, there is a risk of re-infection. If after two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

No adjustment of Lamisil dosing regimen in the form of a spray or solution is required at elderly people.
Experience with Lamisil spray, solution, gelat children limited, and therefore the use of the drug in children is not recommended. Lamisil cream is not recommended for use. in children under the age of 12.

Most often (with a frequency of 1 to 10%) symptoms of the gastrointestinal tract are noted (feeling of fullness in the stomach, loss of appetite, dyspepsia, nausea, mild abdominal pain, diarrhea), mild skin reactions (rash, urticaria), musculoskeletal reactions (arthralgia, myalgia).
With a frequency of 0.1 to 1% there are violations of taste, including their loss (recovery occurs within a few weeks after stopping treatment).
Seldom (with frequency from 0.01 to 0.1%) Hepatobiliary disorders (primarily associated with cholestasis) have been reported in connection with treatment with Lamisil, including and cases of liver failure. Cases of liver failure have been reported, some of which have been fatal or liver transplanted, but in most cases patients had serious comorbidities, and the association of cases of liver failure with Lamisil was regarded as questionable.
There are reports of very rarely (with a frequency of less than 0.01%) occurrences such as serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylactoid reactions. If a progressive skin rash develops, treatment with Lamisil should be discontinued. There are also reports of very rare hematological disorders, such as neutropenia, agranulocytosis or thrombocytopenia. There are reports of very rare cases of hair loss, although the causal relationship of this phenomenon with taking the drug has not been established.
Lamisil is generally well tolerated. Side effects are usually mild or moderate and transient.
Local reactions: redness, itching, or burning.
Other: allergic reactions.

Hypersensitivity to the drug.

Since the clinical experience with Lamisil in pregnant women is very limited, the drug should not be used during pregnancy unless the potential therapeutic effect does not exceed the possible risk of therapy.
Terbinafine is excreted in breast milk, so if you need to use the drug during lactation, you should decide on the termination of breastfeeding.

Unlike Lamisil for topical administration, Lamisil for oral administration is not effective in multi-colored lichen.
If during the treatment with Lamisil, the patient has symptoms that suggest liver dysfunction such as unexplained persistent nausea, vomiting, lack of appetite, fatigue, jaundice, pain in the right hypochondrium, dark urine or discolored feces, in this case it should be confirmed symptoms (determination of serum concentrations of ALT, AST) and cancel treatment with Lamisil. The patient should be warned about the need to consult a doctor if he develops similar symptoms.
Since prospective clinical studies on the use of Lamisil in patients with concomitant chronic or active liver diseases have not been conducted, its purpose is not recommended for this group of patients.
Patients with impaired renal function (creatinine clearance less than 50 ml / min or serum creatinine level more than 300 µmol / l) should receive half the usual dose of the drug.
In vitro studies have revealed that terbinafine inhibits metabolism mediated by the enzyme 2D6 cytochrome P system₄₅₀(CYP2D6). Therefore, it is necessary to monitor patients receiving Lamisil at the same time as medication predominantly metabolized with this enzyme, such as tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors and MAO inhibitors of type B, if used simultaneously the drug has a small therapeutic concentration range.
Influence on ability to drive motor transport and control mechanisms
Data on the effect of Lamisil on the ability to drive a car and work with machinery is missing.

Symptoms: There are reports of several cases of overdose (the accepted dose of the drug was up to 5 g), in which there was a headache, nausea, pain in the epigastric region and dizziness.
Treatment: measures for the removal of the drug, primarily through the appointment of Activated carbon and gastric lavage, and, if necessary, the use of symptomatic maintenance therapy.

In vitro and healthy volunteer studies show that terbinafine has little potential for suppressing or increasing the clearance of most drugs that are metabolized with the participation of the cytochrome P system.₄₅₀ (for example, cyclosporine, terfenadine, triazolam, tolbutamide, or oral contraceptives).
In vitro studies have nevertheless revealed that terbinafine inhibits a CYP2D6-mediated metabolism. These data obtained in experiments in vitro may be clinically significant for those drugs that are predominantly metabolized by this enzyme, such as tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors and MAO inhibitors of type B, - if used simultaneously has a small therapeutic concentration range.
In patients who took Lamisil and oral contraceptives at the same time, in some cases, the menstrual cycle was irregular, although the incidence of these disorders remained within the range observed in patients using only oral contraceptives. On the other hand, the total clearance of terbinafine can be accelerated by those drugs that speed up metabolism (such as rifampicin), and can be slowed down by drugs that inhibit the activity of cytochrome P enzymes₄₅₀ (such as cimetidine). In those cases where the simultaneous use of these drugs is necessary, an adequate dose adjustment of Lamisil may be required.

The drug should be protected from light. Store at a temperature not exceeding 30 ° C, out of the reach of children.