Lomexin vaginal capsules 1000mg №1×1

Name:
Lomexin caps.vag. 1000mg in bl. in pack. No. 1×1
Description:
Soft, oval, shiny capsules of pale yellow color. The main active ingredient Fenticonazole nitrate Release form Vaginal capsules 600 mg and 1000 mg. 1 or 2 capsules in a blister made of PVC / PVDC – aluminum foil. One blister with instructions for use in a cardboard box. Dosage 1000 mg Precautions 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 abdomen or dysuria. – any side effects such as erythema, itching or rash associated with the treatment. It is advisable to start the course of treatment after menstruation. Vaginal capsules should not be used in combination with barrier contraceptives. To avoid reinfection, it is recommended to simultaneously treat the partner with a cream (Lomexin, vaginal cream 2%), which is applied to the glans penis and foreskin. The use of topical preparations, especially for a long time, can cause sensitization. In this case, you should stop using and consult a doctor. Some of the auxiliary ingredients of vaginal capsules (parahydroxybenzoates) may cause allergic reactions (including delayed ones). With the development of local hypersensitivity reactions and allergic reactions, it is necessary to stop using the drug, contact your doctor and start appropriate treatment. 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. Feticonazole also exhibits both in vivo and in vitro activity against Thrichomonas vaginalis. 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 Systemic absorption of fenticonazole when administered vaginally is negligible: pharmacokinetic studies conducted in two groups of patients receiving fenticonazole nitrate at a dose of 1000 mg administered vaginally show that absorption in patients with vulvovaginal candidiasis averages 1.81 ± 0.57%; while in patients with normal vaginal mucosa or cervical cancer, the absorption range is between 0.58% and 1.12%. Indications for use Lomexin 600 mg Candidiasis of the mucous membrane of the genital organs (vulvovaginitis, colpitis, infectious discharge). Lomexin 1000 mg Trichomonas colpitis Mixed vaginal infections caused by Trichomonas vaginalis and Candida Albicans. Candidiasis of the mucous membrane of the genital organs (vulvovaginitis, colpitis, infectious discharge). Dosing and Administration Safety and efficacy data 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. Lomexin 600 mg vaginal soft capsules: 1 vaginal capsule 600 mg in the supine position, deep into the vagina, once at bedtime. If symptoms persist, re-application is possible after 3 days. Lomexin 1000 mg vaginal soft capsules: in the treatment of vaginal infections caused by Trichomonas vaginalis, as well as mixed vaginal infections caused by Trichomonas and Candida Albicans, it is advisable to use vaginal capsules 1000 mg with repeated administration after 24 hours, if necessary. When infected with fungi of the genus Candida: 1 vaginal capsule (1000 mg) at bedtime once. If symptoms persist, re-introduction after 3 days is possible. Vaginal softgels must be inserted deep into the vagina (to the level of the fornix). 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. Breast-feeding Animal oral studies 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. Reproductive function Human reproduction studies have not been conducted with fenticonazole, however, animal studies have not shown any effect of the drug on reproductive function. recurrent (more than 2 infections in the last 6 months) – if there have been cases of sexually transmitted diseases or contact with an infected partner in the past – if the patient is under 16 or over 60 years old – if hypersensitivity to imidazoles or other antifungal drugs is known – the presence of abnormal or irregular vaginal bleeding – vaginal discharge that is stained with blood – the appearance of vulvar or vaginal inflammation, ulcers or blisters – sensations of pain in the lower abdomen or dysuria. – any side effects such as erythema, itching or rash associated with the treatment. It is advisable to start the course of treatment after menstruation. Vaginal capsules should not be used in combination with barrier contraceptives. To avoid reinfection, it is recommended to simultaneously treat the partner with a cream (Lomexin, vaginal cream 2%), which is applied to the glans penis and foreskin. The use of topical preparations, especially for a long time, can cause sensitization. In this case, you should stop using and consult a doctor. Some of the auxiliary ingredients of vaginal capsules (parahydroxybenzoates) may cause allergic reactions (including delayed ones). With the development of local hypersensitivity reactions and allergic reactions, it is necessary to stop using the drug, contact your doctor and start appropriate treatment. Interaction with other drugs Interaction studies have not been conducted. The excipients contained in the preparation, containing fat and oils, can violate the integrity of contraceptives made from latex. The patient should be advised to use alternative methods of contraception/protective measures while using this product. Contraindications Hypersensitivity to the active substance or to any of the auxiliary components of the drug. Due to the presence of soy lecithin, it is contraindicated in patients with peanut or soy allergy. Composition of one capsule: Active ingredient: Fenticonazole nitrate 600 mg or 1000 mg Excipients: Soy lecithin (E322), liquid paraffin, petrolatum, gelatin, glycerol (E422), titanium dioxide (E171), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate ( E217). Overdose Due to the low degree of absorption into the systemic circulation, an overdose is unlikely. Side effects If the recommendations for use are followed, no systemic adverse reactions are expected, except perhaps poor absorption of the drug. After application, a mild, transient burning sensation is possible. Prolonged use of topical preparations may cause sensitization. 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 ? 1/10000 to < 1/1000), very rarely (from < 1/10000), the frequency is unknown (the frequency cannot be calculated from the available data). Reproductive system disorders: very rarely - a burning sensation in the vulvovaginal region. Diseases of the skin and subcutaneous tissues: very rarely - erythema, itching, rash. If you notice any other side effects not listed in the instructions, tell your doctor. Collection of reports of suspected adverse reactions The collection of reports of suspected adverse reactions in the post-registration period is very important, as it allows for continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report suspected adverse reactions through the national reporting system. Storage conditionsStore at a temperature not exceeding 30°C. Keep out of the reach of children. Buy Lomexin vaginal capsules 1000mg No. 1x1