Composition, form of production and packaging
? Spray for external use 1% in the form of a transparent or slightly opalescent, colorless or with a yellowish tinge of liquid.
1 g 1 fl.
terbinafine hydrochloride 10 mg 200 mg
Excipients: propylene glycol, macrogol 300 (polyethylene glycol 300), ethanol 96%, purified water.
20 ml - polymer bottles with a spray gun (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Antifungal drug for external use, allylamine derivative with a wide range of antifungal activity. Specifically, it changes the early stage of sterol biosynthesis occurring in fungi. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.
In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trichophyton rubrum, T.mentagrophytes, T.verrucosum, T. violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), moldy (mainly C. albicans) and certain dimorphic fungi ( Pityrosporum orbiculare). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.
Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other medications.
PHARMACOKINETICS
With topical application, absorption is less than 5%, has a minor systemic effect.
INDICATIONS
- prevention and treatment of fungal infections of the skin, incl. mycosis feet (foot fungus), inguinal epidermophytia (tinea cruris), fungal lesions of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including T. rubrum, T. metagrophytes, T. Verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;
- Multicolored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).
DOSING MODE
Outwardly.
Adults and children from the age of 12: the spray is applied to the affected areas of the skin (after cleansing and drying) and adjacent areas 1 or 2 times / day in an amount sufficient to thoroughly moisturize. Average duration and frequency of application of the drug: dermatomycosis of the trunk, shins - 1 week, 1 time / day;dermatomycosis of the feet - 1 week, 1 time / day; multi-colored lichen - 1 week, 2 times / day.
Elderly patients: the dosage regimen of the drug in the elderly does not differ from the one described above.
SIDE EFFECT
Redness in the place of application, a sensation of itching or burning, but these phenomena rarely led to the need to stop treatment.
Rarely: allergic reactions.
CONTRAINDICATIONS
- children's age till 12 years;
- Hypersensitivity to the components of the drug.
With caution : hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.
PREGNANCY AND LACTATION
In experimental studies teratogenic properties of terbinafine were not revealed. Until now, there have been no reports of any developmental defects in the use of the drug. However, since there is no data on the safety of terbinafine during pregnancy, it should be used only on strict indications, when the expected positive effect of treatment for the mother exceeds the potential risk to the fetus.
Terbinafine is excreted in breast milk. However, in the case of terbinafine feeding the mother in the form of a spray, only a small amount of active substance is absorbed through the skin, so it is unlikely that the baby will be adversely affected. However, due to the lack of sufficient experience in the use of the drug during breastfeeding, breastfeeding should be discontinued at the time of treatment.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution : kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution : liver failure.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
APPLICATION IN ELDERLY PATIENTS
Elderly patients: the dosage regimen of the drug in the elderly does not differ from the one described above.
SPECIAL INSTRUCTIONS
The drug is intended for external use only. It should be avoided getting on the mucous membrane of the eyes. In case of contact with eyes, rinse with plenty of running water, and in case of persistent irritation, consult a physician. If the drug was accidentally injected into the respiratory tract by inhalation, then, in case of any symptoms, and especially when they are preserved, it is necessary to consult a doctor. When developing allergic reactions, it is necessary to cancel the drug.
With caution, apply Lamella in a dosage form spray on damaged areas of the skin. alcohol can cause irritation.
Reduction in the severity of clinical manifestations of the disease is usually observed in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of recurrence of the infection. In the event that after a week after the start of treatment there are no signs of improvement, the diagnosis should be verified.
When treating Lamitel, general hygiene rules should be followed to prevent re-infection (through underwear, shoes).
OVERDOSE
There were no reported cases of overdose with topical application of the drug. If you randomly take the drug inside, the following symptoms are possible : headache, nausea, epigastric pain, dizziness. It should also take into account the presence of ethanol in the formulation.
Treatment: activated charcoal, if necessary - symptomatic therapy.
DRUG INTERACTION
When using the drug in the form of a spray, interactions with other medicinal products are unknown.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Keep out of the reach of children at a temperature of 15-25 В° C in the original packaging. Shelf life - 3 years. Do not use after the expiration date printed on the package.
