Terbinafine cream 10mg/g 15g №1

Name:
Terbinafine cream for nar.prim.10mg/g in tubes 15g in pack No. 1
Description:
Cream from white to white with a yellowish tinge of color with a slight specific odor. The main active ingredient Terbinafine Release form Cream Dosage 10 mg / g Pharmacological action Terbinafine belongs to the group of allylamines. It is a topical antifungal drug with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect on dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum, molds (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare). against yeast fungi, depending on their species, it can be fungicidal or fungistatic.Terbinafine specifically changes the early stage of sterol biosynthesis occurring in fungi.This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell.The action of terbinafine is carried out by inhibition of the enzyme squalene epoxidase located on the cell membrane of the fungus.This enzyme is not part of the cytochrome P450 system, so terbinafine does not affect the metabolism of hormones or other drugs. ie, ringworm of the feet, smooth skin, or natural folds caused by dermatophytes such as Trichophyton (eg, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum; skin candidiasis caused by fungi of the genus Candida (for example, Candida albicans): versicolor (pityriasis) versicolor, caused by Pityrosporum orbiculare (Malassezia furfur). Dosage and administration Adults and children over 12 years of age. The cream is applied in a thin layer, slightly rubbing, on the affected skin, previously cleaned and dried, as well as on the surrounding affected areas 1-2 times a day. In case of infections localized in areas of natural folds (under the mammary gland, in the interdigital spaces, between the buttocks, in the groin), the places where the cream is applied can be covered with a gauze bandage. Recommended treatment regimens: Dermatomycosis of smooth skin, natural folds, feet (interdigital): 1 time per day for 1 week. Dermatomycosis of the feet plantar (“moccasin type”): 2 times a day for 2 weeks. Skin candidiasis: 1-2 times a day for 1 week. Multicolored deprive: 1-2 times a day for 2 weeks. The efficacy of terbinafine cream has not been studied in patients with tinea pedis associated with severe onychomycosis. Special recommendations: Elderly patients. There is no evidence that older patients require different dosages or experience side effects that are not seen in younger patients. Children. The safety and efficacy of terbinafine cream in children under 12 years of age have not been systematically studied. Due to lack of clinical experience, the use of the cream in children under 12 years of age is not recommended. A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination, there is a risk of recurrence of the infection. If after 1 week of treatment there are no signs of improvement, the diagnosis should be verified. Use during pregnancy and lactation Controlled studies in pregnant women have not been conducted. Animal studies have shown no risk to the fetus. When applied topically, less than 5% of the applied amount of terbinafine is absorbed. During pregnancy, the cream should not be used if there are no absolute indications. Terbinafine is excreted in breast milk in small amounts. It is not known whether this small amount in mother’s milk can have a negative effect on the baby, so terbinafine should not be used in nursing mothers. Babies should not come into contact with treated skin areas. Influence on the ability to drive vehicles and other potentially dangerous mechanisms No studies have been conducted. PrecautionsIrregular use of the drug and premature termination of treatment lead to a relapse of the disease. When applying the cream, you should follow the rules of personal hygiene to prevent re-infection through underwear or shoes. During and at the end of treatment, it is necessary to carry out antifungal treatment of shoes, socks, underwear. Terbinafine cream is for external use only. The composition of the medicinal product includes excipients: cetyl and stearyl alcohols, which can cause local skin reactions (for example, contact dermatitis). Avoid getting the drug on the mucous membranes of the eyes, nose, mouth. If the cream gets into the eyes, they should be rinsed with plenty of water. Elderly patients. The dosing regimen of terbinafine cream in the elderly does not differ from that in younger patients. Application in children. The drug is contraindicated in children under 12 years of age (lack of sufficient clinical experience). Interaction with other drugs Drug interaction of terbinafine in the form of a cream is not described. It is possible to use it together with systemic antibiotics (terbinafine, fluconazole, itraconazole). Contraindications Hypersensitivity to terbinafine or to any of the excipients that make up the cream; children’s age up to 12 years. Ingredients per tube active substance – terbinafine hydrochloride – 150.0 mg, excipients – benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, sodium hydroxide, purified water. OverdoseSymptoms Due to low systemic absorption, an overdose of terbinafine when applied topically is unlikely. Accidental ingestion of two tubes of cream containing 300 mg of terbinafine hydrochloride is comparable to taking one 250 mg tablet (corresponding to the standard adult oral dose). If large amounts of terbinafine cream are inadvertently swallowed, the expected side effects are similar to those observed after an overdose of terbinafine tablets. These include headache, nausea, epigastric pain, and dizziness. Treatment Removal of unabsorbed substance by administration of activated charcoal and, if necessary, symptomatic and supportive therapy. Side effects Local symptoms may occur, such as itching and burning sensation, skin peeling, soreness and irritation at the site of application, pigmentation disorders, erythema and crusts. These less serious side effects should be distinguished from rare hypersensitivity reactions (eg, generalized rash and / or redness, urticaria, angioedema), the development of which requires discontinuation of treatment. In case of accidental contact with the eyes of terbinafine hydrochloride, irritation may occur. In rare cases, an exacerbation of a fungal infection is possible. The incidence of side effects is given in the following gradation: very often (?1/10); often (?1/100, <1/10); infrequently (?1/1000, <1/100); rarely (?1/10000, <1/1000); very rarely (<1/10000); the frequency is unknown (it is not possible to determine the frequency of occurrence from the available data). Immune system disorders Very rare: hypersensitivity reactions (urticaria, angioedema, anaphylactic shock). Visual disturbances Rare: eye irritation. Skin and subcutaneous tissue disorders Common: skin peeling, itching. Infrequently: crusts, skin damage and skin irritation, pigmentation disorders, erythema, burning sensation. Rare: dry skin, contact dermatitis, eczema. Frequency unknown: rash. General disorders and reactions at the injection site Uncommon: pain or irritation at the application site. Rare: exacerbation of the underlying disease. In the event of adverse reactions, including those not listed in the instructions for use, you must stop taking the drug and consult a doctor. Storage conditionsAt temperatures from 15°C to 25°C. Keep out of the reach of children. Buy Terbinafine cream 10mg/g 15g №1 Price for Terbinafine cream 10mg/g 15g №1Instruction for use for Terbinafine cream 10mg/g 15g №1