Terbinafine spray for external use 10mg/1ml 25ml №1

Name:
Terbinafine spray 10mg 1ml in vial 25ml with spray nozzle in pack No. 1
Description:
Transparent colorless or yellowish solution. The main active substance Terbinafine Release form Spray Dosage 25 ml Pharmacological properties Terbinafine is an allylamine derivative with a wide spectrum of antifungal activity. At therapeutic concentrations, terbinafine has a fungicidal effect against yeast-like, dimorphic fungi, as well as dermatophytes. The action of terbinafine can be fungicidal or fungistatic, depending on the type of mushroom. Terbinafine specifically inhibits the early stage of sterol biosynthesis in the fungal cell. Terbinafine acts by inhibiting squalene epoxidase in the cell membrane of the fungus. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell. The enzyme squalene epoxidase does not belong to the cytochrome P 450 system, so terbinafine does not affect the metabolism of hormones or other drugs. Terbinafine is effective against dermatophytes of the genera Trichophyton, Microsporum, Epidermophyton, yeast-like fungi of the genus Candida (mainly Candida albicans), as well as Pityrosporum orbiculare (Malassezia furfur) – the causative agent of pityriasis (colorful) lichen. Indications for use: fungal infections of the skin, including mycoses of the feet (“fungus” of the foot), inguinal epidermophytosis (tinea cruris), fungal lesions of the smooth skin of the body (tinea corporis), caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum .; versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur). Terbinafine is used once or twice a day, depending on the indication. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is sprayed onto the affected areas of the skin from a distance of 10-15 cm, pressing the spray nozzle, in an amount sufficient to thoroughly moisturize them, and, in addition, applied to the adjacent areas of the skin. Duration of treatment and frequency of use of the drug: ringworm of the trunk, legs – 1 time per day for 1 week; tinea pedis – 1 time per day for 1 week; versicolor versicolor – 2 times a day for 1 week. A decrease in the severity of clinical manifestations is 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. In the event that after 1-2 weeks of treatment there are no signs of improvement, the diagnosis should be verified. The efficacy and safety of terbinafine spray for the treatment of “moccasin” type foot fungus, as well as severe foot fungal infections with concomitant onychomycosis, have not been studied. Elderly patients There is no evidence that the dosage of the drug should be changed for the elderly or that they experience adverse reactions that differ from those in younger patients. Correction of the dosing regimen of Terbinafine spray in elderly patients is not required. Use during pregnancy and lactation Pregnancy There are no controlled studies on the safety of terbinafine during pregnancy and lactation. Animal studies have not shown any risk to the fetus. When applied topically, less than 5% of the drug dose is absorbed. During pregnancy, the use of Terbinafine is not recommended, unless the expected benefit of therapy outweighs the potential risk. Breast-feeding Terbinafine is excreted in breast milk in small amounts. It is not known whether this small amount in the mother’s milk can have a negative effect on the baby. Therefore, Terbinafine should not be used in nursing mothers. Babies should not come into contact with treated skin areas. Precautions Terbinafine Spray is for external use only. Avoid contact with eyes. Terbinafine may cause eye irritation and therefore should not be used on the face. In case of accidental contact of the drug with the eyes, they should be rinsed with running water, and in case of persistent irritation, it is necessary to consult a doctor. Care should be taken when spraying terbinafine on damaged areas of the skin, as the composition of the drug includes alcohol and propylene glycol. which may cause irritation. When treating with terbinafine, general hygiene rules should be observed to prevent the possibility of re-infection (through underwear, shoes, etc.). Interaction with other drugs The interaction of terbinafine topical solution with other drugs is unknown. Contraindications Hypersensitivity to terbinafine and to any auxiliary component of the drug. Composition 1 ml of solution contains 10 mg of terbinafine hydrochloride as an active substance. Excipients: ethyl alcohol, purified water, macrogol 400, propylene glycol. OverdoseSymptoms Due to the low systemic absorption when applied topically, an overdose of terbinafine is unlikely. If terbinafine is accidentally taken orally, side effects similar to those observed after an overdose of terbinafine tablets, such as headache, nausea, epigastric pain and dizziness, can be expected. It should also take into account the content of ethyl alcohol in the preparation of 27% (m/v). Treatment Measures to eliminate terbinafine primarily by administration of activated charcoal and gastric lavage are recommended, and, if necessary, the use of symptomatic supportive therapy. Side effects At the site of application of the drug, local symptoms may appear, such as itching, peeling, pain or irritation, skin pigmentation disorders, burning, erythema or scab. These minor symptoms should be distinguished from rare allergic reactions, including rash, the development of which requires immediate discontinuation of treatment. In case of accidental contact of terbinafine hydrochloride with eyes, irritation may occur. Rarely, the underlying fungal infection may worsen. The frequency of occurrence of adverse reactions is estimated as: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10000 to <1/1000); very rarely (<1/10000). Immune system: very rarely - urticaria; isolated cases - Quincke's edema, anaphylactic shock. On the part of the organ of vision: rarely - irritation. From the skin: often - peeling, itching; infrequently - skin lesions, scabs, pigmentation, erythema, burning sensation; rarely - dry skin, contact dermatitis, eczema; very rarely - rash or papules. General disorders: infrequently - pain, pain or irritation at the site of application; rarely - exacerbation of the underlying disease. If any side effect occurs or worsens, whether it is described in this section or not, you should contact your doctor immediately. Storage conditionsKeep in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Terbinafine topical spray 10mg/1ml 25ml №1