Lamisil Cream for foot fungus treatment, cream 1%, 15g

Product description

Lamizil cream is used for the prevention and treatment of fungal infections of the skin, including foot fungus. The Active ingredient of the cream Lamisil terbinafine has a fungicidal effect, with which it fights the infection that causes fungi (mycosis) of the foot. * Suitable for use in adults and children from 12 years of age. ** Instructions for medical use, RU No. P N008851 from 10.06.2010

Composition

>of 1 g of cream contains:

Active ingredient:

terbinafine hydrochloride 10 mg;

Auxiliary substances:

benzyl alcohol;

sodium hydroxide;

sorbitan stearate;

cetyl palmitate;

stearyl alcohol;

cetyl alcohol;

polysorbate 60;

isopropyl myristate;

purified water.

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®.

Recommendations for use

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.

Contraindications

Hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug; breast-feeding period; children under 12 years of age.

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 and children over 12 years of age, Lamizil ® cream 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 cream is applied in a thin layer on the affected skin and adjacent areas and rubbed lightly. For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night. For extensive fungal lesions of the body, it is recommended to use the cream in tubes of 30 g. The average duration of treatment and the frequency of use of the drug for dermatomycosis of the trunk, legs is 1 week 1 time/day; for dermatomycosis of the feet – 1 week 1 time/day; for keratinization, cracks, itching and peeling of the skin caused by foot fungus – 2 weeks 1-2 times/day; for candidiasis of the skin – 1-2 weeks 1-2 times/day; for multi – colored lichen-2 weeks 1-2 times/day day. A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. With irregular use or premature discontinuation of treatment, there is a risk of recurrent infection. If there are no signs of improvement after 1-2 weeks of therapy, the diagnosis should be verified. Correction of the dosage regimen of Lamizil cream in elderly patients is not required.

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

Cream for external use is white, uniform or almost uniform, smooth, with a faint characteristic smell.

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

Cream for external use.

Storage conditions

At a temperature not exceeding 30 °C (do not freeze).

Shelf life

3 years

Active ingredient

Terbinafine

Dosage form

cream