Description overdue on 09/12/2014
- Latin name: Lamicon
- ATC code: D01AE15
- Active substance: Terbinafine (Terbinafine)
- Manufacturer: PJSC "Farmak", Ukraine
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions for use
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Synonyms
- Babies
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
1 gram of cream, spray and dermgelya (gel) Lamikon preparation includes 10 mg terbinafine as an active ingredient.
Additional ingredients cream: soft white paraffin, cetostearyl alcohol and phenylethyl, sodium hydroxide, mineral oil, macrogol cetostearyl ether 20, poloxamer 407, propylene glycol, purified water.
Additional spray ingredients: propylene glycol, benzoic acid, macrogol cetostearyl ether 20, disodium edetate, poloxamer 407, water for injection.
Additional ingredients dermgelya: benzyl alcohol, butyl-hydroxytoluene, sorbitan laurate, isopropyl myristate, polysorbate 20, ethanol 96%, sodium hydroxide, carbomer 974P, purified water.
1 tablet contains 250 mg Lamikon terbinafine as an active ingredient.
Additional tablet ingredients: sodium starch glycolate, microcrystalline cellulose, colloidal anhydrous silica, corn starch, magnesium stearate, hydroxypropyl methyl cellulose.
Product form
The drug is manufactured by Lamikon "Pharmak" crme 15 grams to 25 grams of a spray, gel 15 and 30 grams, and tablets of 14 or 28 units per first package.
Pharmacological action
Antifungal.
Pharmacodynamics and pharmacokinetics
Antifungal terbinafine It is alilaminom , Take an active impact on the fairly large number of fungal strains . Fungicide action terbinafine, in adequate concentration, extends to fungi, dermatophytes and dimorphic fungi some. Regarding yeasts, depending on their type, terbinafine exhibits fungicidal or fungistatic efficacy.
The mechanism of action Lamikona inhibition is specific, the cell membrane in fungi early stage sterol biosynthesis . The consequence of this is the impact of intracellular cumulation squalene and lack of ergosterol That leads to the destruction of fungal cells.
Action terbinafine through the process shown inhibition in cell membranes of fungi enzyme squalene epoxidase Belonging to the system P450 . Lamikon has no influence on the effects of other drugs, and metabolism of hormones. For external (local) application absorption of terbinafine is less than 5% of the applied dose, and therefore, it is negligible systemic exposure.
When topically Lamikon absorbed in very small quantities, its effect begins almost immediately and remains effective for a short time, about five days 7-14. The fungicidal effect of terbinafine, by maintaining its desired concentration in the stratum corneum epidermis Obtained during the treatment continues for 7 days after the cancellation of external funds.
For internal pill Lamikon, terbinafine It accumulates in nails, hair and skin, in concentrations providing its fungicidal effects. Absorption of the drug in the form of tablets, about 70%, and the absolute Bioavailability About 50%.
After a single oral 250 mg, 90 minutes Cmax observed in the blood, is 1, 3 mg / ml. As compared with a single dose, at steady state, terbinafine Cmax greater than about 25%, with an increase in blood AUC 2, three times. The effective T½ of approximately 30 hours. Food intake has little effect on the bioavailability Lamikona not require dose adjustments.
The plasma protein binds to terbinafine by 99%. The drug is rapidly penetrates the dermis and accumulates in the stratum corneum. Provided also sebaceous glands and it is found in high concentrations in the hair, hair follicles and integuments . In the first weeks of treatment penetrates Nail Records .
Metabolism terbinafine passes quickly enough, with the participation of P450 . After the process of biotransformation , Lamikona inactive metabolites derived mainly kidneys.
With renal failure and / or liver slowing the rate of excretion of terbinafine, which makes its concentration in the blood higher.
Indications
All local Lamikon drug dosage forms (cream, spray, gel) intended for the treatment:
- fungal infections skin caused by fungi of the genus Microsporum . Trichophyton . Epidermophyton ( dermotofitii groin, feet, torso, etc.);
- colored (pityriasis) depriving Which has arisen due to the impact of fungus Malassezia (Pityrosporum) ;
- candidiasis skin provoked Candida species .
The oral form of the drug Lamikon - tablets used for the treatment of:
- fungal infections of the skin In the case where the concentration of lesions, their prevalence or severity, are reason enough for oral treatment;
- fungal infections of the scalp and onychomycosis (nail infections).
Tablets are not indicated for the treatment of colored (pityriasis) depriving .
Contraindications
The only absolute contraindication for all dosage forms is Lamikona hypersensitivity to its components: terbinafine or additional ingredients.
Periods pregnancy . breast-feeding and children's age is a relative contraindication to receiving Lamikona all dosage forms.
Side effects
When using external preparation forms may be a manifestation of local reactions, such as: burning or peeling of the skin . itch . irritation and pain . pigmentation disorders , Crusting, erythema in the treated area, and others. These reactions rarely led to discontinuation of therapy and generally disappear on their own.
It is necessary to distinguish the above reaction from some Possibly Related allergic reactions : itch skin . hives . rash on the skin (including bullous ), Which is rare, but often require discontinuation of treatment. Therefore, upon detection of any adverse events should be reported to the attending physician.
Also observed eye irritation Accidental contact with them terbinafine.
In a particularly rare cases may worsen before hidden fungal infection .
Treatment with tablets Lamikon usually tolerated without serious side effects, although in some cases, the following symptoms:
Blood system:
- agranulocytosis ;
- neutropenia ;
- pancytopenia ;
- thrombocytopenia.
The immune system:
- Lyell's syndrome ;
- anaphylactoid reactions (including angioedema );
- Stevens-Johnson syndrome ;
- system and skin symptoms SLE ;
- photosensitization .
Nervous system:
- taste disturbances;
- headache ;
- hypoesthesia ;
- dizziness ;
- paresthesia .
Bodies of the digestive tract:
- a feeling of fullness;
- dyspepsia ;
- loss of appetite;
- nausea ;
- diarrhea ;
- stomach ache.
Skin and subcutaneous tissue disorders:
- skin reactions are mild ( hives . rash );
- exacerbation of psoriasis or psoriasiform rash;
- sharp generalized exanthematous pustulosis (rarely);
- hair loss (unproven causality).
Musculoskeletal system:
- myalgia ;
- arthralgia .
Hepatobiliary System:
- increase in liver enzymes;
- hepatobiliary dysfunction (basically cholestatic );
- isolated cases have been described liver abnormalities heavy nature ( jaundice . cholestasia . hepatitis ).
General:
- feeling tired (very rare).
Instructions for use
Instructions on Lamikon spray, cream and gel involves the use of these dosage forms only externally. Before using external funds should first clean and dry the affected skin.
Depending on the exciter and severity of cream Lamikon, instructions for use recommends applying 1-2 times throughout the day. Spray Lamikon also be applied from 1 to 2 times, while Lamikon dermgel applied once a day.
Cream and gel is applied to the the affected skin and adjacent areas of the skin with a thin layer and gently rub. In the case of infection accompanied intertrigo, for example in the groin, between the toes, under the breasts, etc. between the buttocks, the treated areas can be covered with gauze, especially at night.
Spray in sufficient quantity to visible moisture is sprayed onto the skin fungal attack As well as adjacent healthy skin.
Duration of treatment with the use of local resources, depending on its severity, usually takes from 7 to 14 days.
Relief of symptoms of the disease usually occurs within a few days. To be effective, treatment should strictly adhere to the regime applying drugs, do not miss the next appliqué and does not terminate before the recommended period of treatment, as this may lead to relapse.
Elderly patients does not need to be adjusted dose topical preparations.
Tablets Lamikon designate adults and children 6 years of age, with a weight of over 20 kilograms. Pills continued for sufficient time to complete disappearance symptom of disease , Depending on the severity and nature.
Waste Lamikona dose in the form of tablets for adults is - 250 mg, for children weighing 20 to 40 kg - 125 mg, more than 40 kg - 250 mg.
The duration of treatment with the candidiasis of skin . trihofitii skin and perineum generally ranges from 2 weeks to 1 month when Tinea pedis from 2 weeks to 1, 5 months.
Fungal infections of the scalp Most often occurring in children can be treated at the recommended doses over 4 weeks.
Treatment onychomycosis Usually it takes 1 to 5 months for fingernails and 3 months for the toe nail. This low growth nail plates , Treatment may require a longer time.
Overdose
Because of the low systemic absorption of external forms Lamikona his overdose is unlikely. In case of accidental contact with local media inside, as well as the reception of ultrahigh doses of the oral form of the drug, possible manifestations headaches . nausea . dizziness and epigastric pain . In this case, artificially induce vomiting and conduct gastric lavage.
Cooperation
Interactions cream, gel and spray Lamikon with other medicines have been identified.
When the pill may increase the blood clearance terbinafine the parallel use of inductors of its metabolism and reduced clearance when used inhibitors of cytochrome P450 . This combination of drugs require dose adjustment Lamikona.
Terbinafine no effect on clearance of Digoxin or Antipyrine It increases to 82% clearance Desipramine and 15% decreases clearance Cyclosporine .
Rifampicin doubles clearance terbinafine .
Lamikon little effect on the change (in either direction) clearance of drugs metabolism which proceeds with the participation of P450 , such as: Terfenadine . Tolbutamide . Triazolam or oral contraceptives .
Pills Lamikon reduces the clearance of intravenously administered Caffeine 19%.
Terbinafine able to inhibit CYP 2D6-mediated metabolism, which may have clinical implications for drugs metabolized by this enzyme: blockers, β-adrenergic . tricyclic antidepressants SSRIs, antiarrhythmic preparations MAO inhibitors .
Terms of sale
All dosage forms of the drug Lamikon released upon presentation of a prescription.
Storage conditions
Tablets as the outer form of the preparation, stored at 25 ° C.
Shelf life
For all forms - 24 months.
Cautions
Cream, gel and spray Lamikon designed exclusively for external application.
It should not be allowed to enter the external agent in your eye, and if involuntary contact with a sufficient amount of wash water flow.
In order to prevent mycotic reinfection you must regularly change clothes, do not wear a bad leak air or too tight clothing, after washing thoroughly dry problem areas, always use a clean towel personalized. Do not walk barefoot in the athlete's foot. Process spray socks, tights, etc., as well as the inside of the shoe.
Tablets Lamikona not recommended for patients with active or chronic liver disease .
Since the drug has some hepatotoxicity Should assess the condition of the liver, even in healthy patients.
If you find nausea unknown aetiology fatigue . anorexia . vomiting , Right-sided abdominal pain, jaundice , Pale stool or dark urine, the patient must inform your doctor and stop taking the tablets. Then assess the state of the liver.
In case of increase skin rash , Therapy canceled up to determine the cause of these phenomena.
Whenever blood dyscrasia , While taking Lamikona need to consider replacing treatment.
When creatinine clearance less than 50 ml / min is not recommended oral terbinafine .
Analogs
- Amorolak ;
- Mikoseptin ;
- Mikolak ;
- Nitrofungin ;
- Exoderil ;
- Salicylic acid .
Synonyms
- Lamisil ;
- Mikofin ;
- Lamifen ;
- Terbizil ;
- Terbinafine ;
- Ekzifin ;
- Fungotek .
Babies
Children are not recommended to apply the cream and spray up to 12 years, and dermgel 18 years.
Tablets prescribed with extreme caution after the patient ages 6 years old and weight more than 20 kg.
During pregnancy (and lactation)
The drug Lamikon as tablets, and in the outer forms used during pregnancy only in extreme cases and under the supervision of a physician.
With any method of application terbinafine It falls into the milk of nursing mothers. Therefore it is better to give up breast-feeding Lamikonom during therapy.
Reviews Lamikone
Reviews the effectiveness of external forms Lamikon preparation (cream, spray, dermgel), when applied against the sensitive terbinafine mushrooms, the bulk of these are positive. The drug takes effect within a few days leading to the complete disappearance of symptoms fungal disease By the end of therapy, which often last for 7-14 days.
In the case of a heavy defeat for the more effective and rapid treatment is preferable to use a combination of dosage forms of the drug, such as a parallel pills and applying the cream, spray or gel. For treatment of the inner part of the shoe, to prevent R einfitsirovaniya also apply spray Lamikon. Reviews of the tablets of the drug, in compliance with all recommendations of the doctor and the registered indications and contraindications, as well as positive and indicate a high effectiveness of this drug.
Negative comments about Lamikone appearing on user forums may be associated with use of the drug for the treatment of insensitive to him mushrooms or improper use of its dosage forms. In the case before the recommended time interrupted therapy, even in the apparent improvement, relapses of the disease, and non-compliance with the rules of personal hygiene associated with fungal lesions, the spread of fungus to other parts of the body.
Therefore, in cases of suspected the presence of a fungal infection you must set it exactly the pathogen to assign adequate and effective, in this case, the treatment, which can only recommend a dermatologist.
It is worth noting that on the Internet you can often find the instructions on Lamikon ointment, a description of its activities, reviews of ointment guidance on its application, etc., which do not correspond to reality. At this time, the company "Farmak" produces the drug Lamikon only in the form of a cream, spray, dermgelya and tablets. All other described dosage forms of the drug are wrong and most likely the result of lack of understanding the differences between the bases of ointments, creams and gels.
Price Lamikona where to buy
The cost of the drug Lamikon in Ukraine varies depending on the dosage form. On average, the cream can be purchased for 60 hryvnia, dermgel 65 hryvnia, and 75 hryvnia Lamikon spray. Price tablets of the drug varies from 130 to 160 hryvnia for 14 pieces.
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