Lamisil is an antifungal drug that has a wide spectrum of action against fungi that cause skin, nail and hair diseases.
Release form and composition
Lamisil Dosage Forms:
- Oral intake tablets: biconvex, round, from white to white with a yellowish tinge, with a smooth or slightly rough surface, on one side of the risk, chamfer and the inscription (in a circle) "LAMISIL 250" (7 pieces in blisters, 1 blister in a carton box, 14 each in blisters, 1 or 2 blisters in a carton box;
- Spray for external use: clear, colorless or light yellow liquid with a characteristic odor (15 or 30 ml in vials of high-density polyethylene with a spray tip, 1 bottle in a carton box);
- Cream for external use: homogeneous, white, with a faint characteristic odor (15 or 30 g in aluminum tubes, 1 tube in a cardboard box).
The composition of the tablets (in 1 pc.):
- Active ingredient: terbinafine hydrochloride - 250 mg;
- Auxiliary components: methyl hydroxypropyl cellulose, sodium starch glycolate, silicon dioxide anhydrous colloidal, magnesium stearate, microcrystalline cellulose.
The composition of the spray (1 g):
- Active ingredient: terbinafine hydrochloride - 10 mg;
- Auxiliary components: water, ethanol 96%, propylene glycol, macrogol cetostearate.
The composition of the cream (1 g):
- Active ingredient: terbinafine hydrochloride - 10 mg;
- Auxiliary components: sorbitan stearate, sodium hydroxide, isopropyl myristate, cetyl palmitate, cetyl alcohol, benzyl alcohol, stearyl alcohol, polysorbate 60, purified water.
Indications for use
Lamisil tablets is used to treat the following fungal diseases:
- Mycoses of the scalp;
- Onychomycosis caused by dermatophytes;
- Dermatomycoses of the trunk, legs and feet;
- Yeast infections of the skin caused by fungi of the genus Candida (in cases where the severity, prevalence or localization of infection determine the appropriateness of oral therapy).
Lamisil is used externally for the prevention and treatment of such fungal skin infections:
- Yeast infections of the skin, mainly caused by fungi of the genus Candida, in particular diaper rash;
- Mycoses feet; cracks, harshness, peeling and itching of the skin caused by foot fungus;
- Groin athlete's disease, fungal lesions of the smooth skin of the body, caused by such dermatophytes, such as Epidermophyton floccosum, Microsporum canis and Trichophyton (including T. mentagrophytes, T. rubrum, T. violaceum and T. verrucosum);
- The versicolor versicolor caused by Pityrosporum orbiculare (Malassezia furfur).
All dosage forms are contraindicated in case of hypersensitivity to terbinafine or auxiliary components.
In the form of tablets, the drug is not recommended for patients with impaired renal function, active and chronic liver diseases.
Externally, the drug should be used with caution in the following cases:
- Hepatic / Renal Failure;
- Chronic alcoholism;
- Oppression of bone marrow hematopoiesis;
- Metabolic diseases;
- Occlusive vascular diseases of the limbs.
With regard to the use of Lamisil in pediatrics, in children older than 2 years, tolerability of terbinafine, taken orally, is good, but data on the use of the drug in children under 2 years old (or with a body weight less than 12 kg) are not available. The experience of external use of terbinafine in children under the age of 12 years is not enough, therefore, this age category is not recommended to prescribe a spray and cream.
Clinical experience with this drug in pregnant women is very limited, so breastfeeding while taking Lamisil inside should be suspended. Also contact of the newborn with skin treated Lamisil (including with the breast) is not allowed.
Dosing and Administration
Tablets should be taken orally.
Adults appoint 250 mg 1 time per day.
Doses for children depending on body weight:
- More than 40 kg - 250 mg (1 tablet);
- 20-40 kg - 125 mg (1/2 tablet);
- Less than 20 kg - 62.5 mg (1/4 tablet).
The duration of therapy depends on the type and severity of the disease. For the treatment of dermatomycosis of the feet (interdigital, plantar or sock type), it usually takes from 2 to 6 weeks, dermatomycosis of the trunk and lower legs, skin candidiasis - from 2 to 4 weeks, mycosis of the scalp - 4 weeks, onychomycosis - from 6 to 12 weeks In some cases (for example, in people with a low growth rate of nails), a longer treatment is possible.
Outwardly Lamisil is used 1-2 times a day, depending on the evidence. Apply the product should be on thoroughly cleaned and dried parts of the body: spray - spray in an amount sufficient to thoroughly moisturize the affected and adjacent areas, apply the cream with a thin layer on the affected and adjacent areas and lightly rub. For infections with diaper rash (in the inguinal region, between the buttocks, in the interdigital spaces, under the mammary glands), it is recommended to cover the place of application of the cream with gauze, especially at night.
The average duration of treatment and the frequency of application of the cream or spray, depending on the evidence:
- Ringworm of the feet, torso and lower legs - 1 time / day for 1 week;
- Corniness, cracks, peeling and itching of the skin caused by foot fungus, as well as lichen-colored lichen cream - 1-2 times / day for 2 weeks; spray - 2 times / day for 1 week;
- Skin candidiasis - 1-2 times / day for 1-2 weeks.
When you take the drug inside may be the following side effects:
- Hematopoietic system: very rarely - thrombocytopenia, agranulocytosis, pancytopenia, neutropenia;
- Immune system: very rarely - skin and systemic lupus erythematosus, anaphylactoid reactions (including angioedema);
- Nervous system: often - headache; sometimes - violations of taste, incl. their loss (usually restored within a few weeks after discontinuation of the drug); in some cases - dizziness, hypesthesia, paresthesia;
- Hepatobiliary system: rarely - hepatobiliary dysfunction (mostly cholestatic), including isolated cases of severe liver failure, some fatal or requiring liver transplantation (in most cases, liver failure developed in patients with systemic diseases, and its cause-effect relationship with Lamisil was dubious);
- The digestive system: very often - loss of appetite, feeling of fullness in the stomach, mild abdominal pain, nausea, diarrhea, dyspepsia;
- Musculoskeletal system: very often - myalgia and arthralgia;
- Dermatological reactions: very often - mild skin reactions (rash and urticaria); extremely rarely - serious skin reactions (including Stevens-Johnson syndrome), exacerbation of psoriasis or psoriasis-like skin rashes, as well as hair loss (a causal relationship with terbinafine has not been established);
- Other: very rarely - feeling tired.
When using the external dosage forms of Lamisil, in some cases, there is a burning sensation, itching, redness of the skin at the site of application, allergic reactions.
Prior to the appointment of the drug in tablets, it is necessary to establish whether the patient has liver disease at the present time or in history. However, it should be borne in mind that hepatotoxicity is possible in people without prior liver disease. For this reason, all patients prescribed Lamisil should be warned that they should immediately see a doctor if they develop symptoms such as anorexia, persistent nausea, pain in the right hypochondrium, vomiting, tiredness, jaundice, bright feces or dark urine. Taking the drug should be discontinued and conduct a study of liver function.
In the case of the appointment of Lamisil tablets, the elderly should take into account the possibility of concomitant renal or liver dysfunction.
Care should be taken when using the drug externally. In case of contact with eyes, rinse immediately with water, in case of persistent irritation, consult a doctor.
Lamisil Spray contains alcohol, which can cause irritation on damaged skin.
In the event that the spray gets into the airways during inhalation, it is also necessary to consult with a medical specialist.
The effect of Lamisil, taken orally, on the ability to concentrate and the speed of reactions has not been studied. With the development of dizziness during the period of treatment it is recommended to refrain from driving and working with mechanisms. When using the drug externally, no negative effect was noted.
Information about drug interactions Lamisil, used externally, is missing.
When taking the drug orally at the same time as drugs that are metabolism inducers or inhibitors of cytochrome P 450 , the plasma clearance of terbinafine may be accelerated, therefore, dose adjustment may be required.
Cimetidine reduces the clearance of terbinafine, increases its concentration in the blood plasma and enhances its action; rifampicin, in contrast, increases clearance, reduces concentration and weakens the effect.
Terbinafine reduces the clearance of caffeine when administered intravenously, increases its concentration and enhances action; increases the clearance of cyclosporine, reduces its concentration and weakens the effect.
Terbinafine inhibits CYP2D6 mediated metabolism. It is necessary to monitor the condition of patients who receive tablets metabolized mainly with the participation of this enzyme, such as beta-blockers, tricyclic antidepressants, type B monoamine oxidase inhibitors, class 1A, 1B and 1C antiarrhythmic drugs, selective serotonin reuptake inhibitors — simultaneously with Lamisil tablets. if they have a small therapeutic concentration range.
Terbinafine reduces the clearance of desipramine by 82%.
There are separate reports of menstrual disorders in women who took Lamisil at the same time as oral contraceptives. However, it is worth noting that the frequency of such violations did not exceed that in patients who took only oral contraceptives.
Terms and conditions of storage
Store at temperatures up to 30 ºС out of the reach of children. Do not freeze.
Shelf life of tablets and cream - 5 years, spray - 3 years.