Product description
Lamisil® The spray is used to treat foot fungus, body fungus, multi-colored lichen, candidiasis of the skin. * Lamisil Spray is convenient to apply to areas affected by the fungus. There is no need to touch the infected areas, so your hands remain clean after treatment. The Active ingredient terbinafine has a fungicidal effect, with which it fights an infection that causes fungi (mycosis) of the foot. ** Instructions for medical use, RU No. P N016003 / 02 of 22.12.2009
Composition
>
of 1 g of spray contains:
Active ingredient:
10 mg of terbinafine hydrochloride;
Auxiliary substances:
macrogol cetostearyl ether,
ethanol,
purified water,
propylene glycol,
nitrogen.
Pharmacological action
Antifungal drug for external use, which has a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), mold (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic. Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and intracellular squalene accumulation, which causes fungal cell death. The action of terbinafine is carried out by inhibiting the squalene oxidase enzyme located on the cell membrane of the fungus. Terbinafine has no effect on the cytochrome P 450 system in humans and, accordingly, on the metabolism of hormones or other drugs.
Clinical pharmacology
When applied topically, the absorption is less than 5%, has a slight systemic effect.
Indications
Prevention and treatment of fungal infections of the skin: foot mycoses (tinea pedis); keratinization, cracks, itching and peeling of the skin caused by foot fungus; inguinal epidermophytia (tinea craris), fungal lesions of the smooth skin of the body (tinea corporis) caused by such dermatophytes 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 fungi of the genus Candida (for example, Candida albicans), in particular diaper rash; multi-colored lichen (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).
Use during pregnancy and lactation
Since the clinical experience with Lamizil® cream in pregnant women is very limited, it should not be used unless absolutely necessary. During pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus. You should consult your doctor. No teratogenic properties of terbinafine were found in experimental studies. To date, no malformations have been reported with Lamizil®. Terbinafine is excreted in breast milk, so the drug should not be prescribed to nursing mothers. Do not allow the baby to come into contact with any surface of the skin treated with Lamizil®.
Contraindications
Hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug; breast-feeding period; children under 18 years of age. With caution, the drug is prescribed to patients with hepatic and / or renal insufficiency, patients with chronic alcoholism, with inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.
Side effects
WHO definition of frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), infrequent (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (Immune system disorders: isolated reports of hypersensitivity reactions (rash). From the side of the organ of vision: rarely-eye irritation. From the skin: often-peeling of the skin, itching; infrequently-skin damage, crusting, skin damage, pigmentation disorder, erythema, burning sensation of the skin; rarely-feeling of dry skin, contact dermatitis, eczema; individual reports-rash. Local reactions: infrequently-pain, pain at the site of application, irritation at the site of application; rarely-exacerbation of symptoms of the disease. In places where the drug is applied, itching, peeling of the skin, pain, irritation, changes in skin pigmentation, burning, erythema, crusts may occur. These minor symptoms should be distinguished from hypersensitivity reactions, such as rash, which occur in rare cases and require discontinuation of therapy. In rare cases, the course of a fungal infection may worsen. If any of these side effects get worse, or the patient notices any other side effects, you should inform your doctor.
Interaction
Currently, the drug interaction of Lamizil® is unknown.
How to take, course of use and dosage
In adults, Lamizil ® spray can be used 1 or 2 times / day, depending on the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is sprayed on the affected areas in an amount sufficient to thoroughly moisten them, and, in addition, it is applied to adjacent areas of both affected and intact skin. For extensive fungal lesions of the body, it is recommended to use the spray in bottles of 30 ml. Frequency of use of the drug and duration of treatment: dermatomycosis of the trunk, lower legs-1 time/day for 1 week; dermatomycosis of the feet-1 time/day for 1 week; multi-colored lichen-2 times/day for 1 week; inguinal epidermophytosis, diaper rash-1 time/day for 1 week.
Overdose
No cases of overdose of Lamizil® have been reported. Symptoms: random oral use of 30 ml of Lamizil® spray containing 300 mg of terbinafine hydrochloride is comparable to taking 1 tablet of Lamizil® with a dosage of 250 mg (a single dose for an adult). If you accidentally take a larger amount of Lamizil® spray inside, you can expect to develop the same side effects as with an overdose of Lamizil® tablets (headache, nausea, epigastric pain and dizziness). Please also note that the spray contains ethyl alcohol (28.87% by volume). Treatment: activated charcoal, if necessary, carry out symptomatic therapy.
Description
Spray for external use in the form of a clear, colorless or light yellow liquid with a characteristic odor.
Special instructions
A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular use or premature discontinuation, there is a risk of recurrence of infection. The drug is intended for external use only. Avoid contact with the drug in the eyes, as it may cause irritation. In case of accidental contact, the eyes should be immediately rinsed with running water, and in case of persistent irritation, consult a doctor. If allergic reactions develop, the drug should be discontinued. Lamizil ® cream for external use contains cetyl and stearyl alcohols, which can cause local allergic reactions (contact dermatitis) at the application sites. Caution should be exercised when applying Lamizil® spray to damaged areas of the skin, as the ethanol contained in its composition can cause irritation. Lamisil® spray is intended for external use only. Do not apply Lamisil® spray to the face. If Lamizil® spray was accidentally introduced into the respiratory tract during inhalation, then, in case of any symptoms, and especially if they persist, it is necessary to consult a doctor. Lamisil® spray contains propylene glycol, which can cause skin irritation in some cases. It should also be taken into account that the drug contains 96% ethanol. The ability to drive vehicles and mechanisms is not affected.
Form of production
Spray for external use.
Storage conditions
At a temperature not exceeding 30 °C (do not freeze)
Shelf life
3 years
Active ingredient
Terbinafine
Dosage form
spray for external use
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Side effects of Lamisil Foot Fungal Spray, 1%, 30ml
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