Lomexin cream for vaginal and external use 2% in tubes 78g №1

Name:
Lomeksin cream for vag. and Nar. approx. 2% in aluminum tubes 78g. in a set with dosing in pack. No. 1
Description:
White homogeneous cream. The main active ingredient is fenticonazole nitrate. Release formCream. Dosage 2% in aluminum tubes 78g. Pharmacodynamics Lomexin is a broad-spectrum antifungal drug. – In vitro: has a fungistatic and fungicidal effect against dermatophytes (all types of fungi of the genus Trichophyton, Microsporum, Epidermophytori), Candida albicans and other pathogens of fungal diseases of the skin and mucous membranes. In vitro inhibitory activity has also been demonstrated against the acid protease secreted by Candida albicans. – In vivo: Guinea pigs with skin mycosis caused by dermatophytes and fungi of the genus Candida recovered within 7 days. Lomexin also has antibacterial activity against Gram-positive bacteria. Proposed mechanism of action: blocks oxidative enzymes due to the accumulation of peroxides, causes necrosis of fungal cells; has a direct effect on membranes. Pharmacokinetics In pharmacokinetic studies, both in animals and in humans, very little absorption of the drug by the mucous membranes was demonstrated. In the treatment of dermatological skin lesions, less than 0.5% of the dose of the drug applied under the occlusive dressing penetrates. After vaginal use of fenticonazole in humans, negligible absorption has been observed: pharmacokinetic studies conducted in two groups of patients treated with fenticonazole nitrate 1000 mg vaginally showed that absorption in patients with vulvo-vaginal candidiasis averages 1.81 ± 0.57% ; while in patients with healthy vaginal mucosa or with cervical cancer, the average absorption is 0.58-1.12%. Indications for use Externally Dermatomycosis caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton), in various localizations: fungal infection of the skin of the extremities, fungal infection of the skin of the feet (“athlete’s foot”), fungal infection of the skin of the hands, fungal infection of the skin of the face, dermatophyte onychomycosis. Skin candidiasis (diaper rash, angular stomatitis, facial candidiasis, diaper candidiasis, inguinal and scrotal candidiasis); balanitis, balanoposthitis; onychomycosis and paronychia. Pityriasis versicolor (caused by Pityrosporum orbiculare and P. Ovale). Otomycosis (caused by Candida or yeast); only in the absence of damage to the eardrum. Erythrasma. Mycosis with the presence of bacterial superinfection (caused by Gram-positive bacteria). Intravaginally Vulvovaginal candidiasis Method of administration and doses Outwardly Lomexin is prescribed for the treatment of skin devoid of hair, skin folds and mucous membranes. The drug is applied 1-2 times a day with a uniform thin layer on previously cleaned and dried affected areas with a capture of about 1 cm of the surface of healthy skin and gently rubbed. It is mainly used in the treatment of dry mycosis: Pityriasis versicolor versicolor, ertirasma, onychomycosis (the cream is applied under an occlusive dressing). Also, the drug is suitable for the treatment of male genital mycoses. The duration of treatment depends on the etiology of the pathogen and the location of the infection. Symptoms of the disease disappear, as a rule, after 2-4 weeks. The recommended duration of treatment is 4 weeks. Lomexin is non-greasy, non-staining and can be easily removed with water. Also, the drug is suitable for the treatment of mycoses of the skin of the male external genital organs. Intravaginally Data on the safety and efficacy of use in children under 16 years of age are not available. For children over 16 years of age, the recommended dose is the same as for adults. One full applicator (about 5 g) is inserted into the vagina with the reusable applicator in the supine position, once a day, at bedtime and, if necessary, in the morning for three days. In the case of vulvitis, the cream can be applied in a thin layer on the surface of the vulva. To avoid reinfection, it is recommended to simultaneously treat the partner with a cream that is applied to the glans penis and foreskin. Application of the dispenser: 1. Attach the dispenser to the tube instead of the cap. 2. Gently squeeze out the contents of the tube until the dispenser is completely filled. If resistance appears, pull the dosing piston slightly up. The dispenser must be completely filled with cream, unless otherwise prescribed by the attending physician. 3. Remove the dispenser filled with cream from the tube (the piston is fully extended). Close the tube with a lid. 4. Insert the dispenser deep into the vagina (as far as possible), in the supine position, knees bent. By pressing on the piston, squeeze out all the cream from the dispenser. After each use, wash the applicator with warm water (not higher than 50 °C) with soap and dry. Use during pregnancy and lactation Pregnancy There is limited data on the use of fenticonazole in pregnant women. Animal studies have shown no teratogenic effects, and embryotoxic and fetotoxic effects have only been observed at very high oral doses. However, even with little transdermal penetration, possible risks cannot be ruled out. With vaginal treatment, low systemic exposure is expected. The applicator should not be used during pregnancy. Both dermatological and vaginal treatment with fenticonazole during pregnancy should be under medical supervision. Breastfeeding Animal studies by the oral route have shown that fenticonazole and/or its metabolites may be excreted in milk. Even in the absence of data indicating that the vaginal use of fenticonazole in humans causes excretion of the drug and/or its metabolites in milk, a risk to the child cannot be ruled out. During breastfeeding, fenticonazole should be used under medical supervision. see a doctor for appropriate treatment. The use of topical preparations, especially long-term use, may cause sensitization. In this case, you should stop using and consult a doctor. Lomexin contains propylene glycol, which can cause skin irritation. The medicinal product also contains lanolin and cetyl alcohol, which may cause local skin reactions (eg contact dermatitis). External application When applied to the affected areas of the skin, a slight burning sensation may occur, which quickly passes. Avoid contact of the drug with the eyes. In case of accidental contact with eyes, rinse with plenty of water. Vaginal use The patient should consult a doctor if: – if the symptoms have not been relieved within one week – if the symptoms recur (more than 2 infections within the last 6 months) – if there have been cases of sexually transmitted diseases in the past, or contact with an infected partner – if the patient is under 16 or over 60 years of age – if hypersensitivity to imidazoles or other antifungals is known – presence of abnormal or irregular vaginal bleeding – vaginal discharge that is stained with blood – occurrence of vulval or vaginal inflammation, ulcers or blisters – sensation of lower pain stomach or dysuria – any side effects such as erythema, itching or rash associated with treatment. Fenticonazole should be used during pregnancy and lactation under medical supervision. During the period of use of the drug, it is recommended to use reliable methods of contraception. During intravaginal application, a slight burning sensation may occur, which quickly passes. It is advisable to start the course of treatment after menstruation. To avoid reinfection, it is recommended to simultaneously treat the partner with Lomexin cream, which is applied to the glans penis and foreskin. The cream should not be used in combination with barrier contraceptives. Interaction with other drugs Interaction studies have not been conducted. Fatty fillers and oils contained in the cream can damage latex contraceptives. Contraindications Hypersensitivity to the active substance or to any of the auxiliary components of the drug. Composition of 1 g of cream: Active substance: Fenticonazole nitrate 20.0 mg Excipients: Water, glyceryl monostearate, disodium edetate, fatty acids and macrogol ester, hydrogenated lanolin, almond oil, propylene glycol (E1520), cetyl alcohol. Overdose No cases of drug overdose have been reported. Fenticonazole has a local effect and is not intended for oral use. In case of accidental ingestion, abdominal pain and vomiting are possible. Side effects Lomexin has a low absorption, and therefore, with its proper use, any systemic adverse reactions are unlikely. Prolonged use of topical preparations may cause irritation. When applied vaginally with an applicator, a slight burning sensation may occur. Side effects are listed according to the MedDRA classification according to the damage to organs and organ systems and the frequency of development: very often (? 1/10), often (from ? 1/100 to < 1/10), infrequently (from ? 1/1000 to < 1/100), rarely (from ? 1/10,000 to < 1/1000), very rarely (from < 1/10,000), the frequency is unknown (the frequency cannot be calculated from the available data). On the part of the skin and subcutaneous tissues (external use): very rarely - erythema, itching, rash, erythematous rash, skin irritation and burning of the skin. On the part of the reproductive system (with vaginal use): very rarely - a burning sensation in the area of application of the drug. On the part of the skin and subcutaneous tissues (with vaginal use): very rarely - erythema, itching, rash. If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children. Buy Lomexin cream for vaginal and external use 2% in tubes 78g No. 1 #1