Active substanceFenticonazoleFenticonazole
Similar drugsTo uncover
  • Lomexin®
    capsules the vagina. 
  • Lomexin®
    cream the vagina. externally 
  • Dosage form: & nbspcream for vaginal and external use
    Composition:100 g of cream contain:

    Active substance:

    Fenticonazole Nitrate

    2.00 grams

    Excipients:

    Water

    60.50 grams

    Glyceride monostearate

    3.00 grams

    Disodium Edetate

    0.50 g

    Fatty acids and macrogol ether

    15.00 g

    Lanolin hydrogenated

    1.00 g

    Almond oil

    10.00 g

    Propylene glycol

    5.00 g

    Cetyl alcohol

    3.00 grams

    Description:White homogeneous cream.
    Pharmacotherapeutic group:antifungal agent
    ATX: & nbsp

    D.01.A.C   Imidazole derivatives

    D.01.A.C.12   Fenticonazole

    Pharmacodynamics:
    Lomexin® is a broad-spectrum antifungal agent for topical and topical application. Fenticonazole (Active ingredient Lomeksina®) is a synthetic derivative of imidazole (its racemic mixture in the form of nitrate salt fenticonazole). Has a local fungicidal and fungistatic effect. It also has antibacterial action.
    The mechanism of action is to inhibit the synthesis of ergosterol, which regulates the permeability of the fungal cell membrane. Active against dermatophytes Trychophyton spp., Microsporum spp., Epidermophyton spp., Pityrosporum orbiculare and P. ovale, yeast fungi Candida spp. (including Candida albicans) and Gram-positive bacteria (Staphylococcus aureus, Streptococcus spp.), as well as in relation to Trichomonas vaginalis.
    Unlike other known azole compounds (in particular, econazole, miconazole and ketoconazole) fenticonazole inhibits biosynthesis of proteases Candida spp. at concentrations below the minimum inhibitory concentration - from 0.25 to 16 μg / ml. This action does not depend on the amount of antifungal activity and is due to the inhibition of one of the stages of the formation of proteolytic enzymes by yeast-like fungi.
    Pharmacokinetics:Fenticonazole practically does not undergo systemic absorption, with prolonged external application, its concentration in the blood is not determined. The degree of absorption by mucous membranes is extremely low.
    Indications:Fungal skin diseases caused by dermatophytes (Trychophyton spp., Microsporum spp., Epidermophyton spp.), yeast-like fungi (Candida spp.), and Pityrosporum orbiculare and P. ovale:
    - facial dermatophytosis, trunk dermatophytosis, inguinal dermatophytosis, dermatophytosis of brushes, dermatophytosis of feet;
    - Candidiasis of the skin (intertriginous candidiasis: candidiasis of skin folds, interdigital candidiasis of feet and hands); Candidiasis of genital skin (balanitis, vulvitis);
    - pityriasis (caused by Pityrosporum orbiculare and R.ovale);
    - vulvovaginal candidiasis, vaginal trichomoniasis.
    Contraindications:

    Hypersensitivity to fenticonazole and other components of the drug, pregnancy, the period of breastfeeding, age to 18 years.

    Pregnancy and lactation:

    Due to the lack of data for the safe use of Lomexin® cream during pregnancy and lactation, the use of the drug during these periods is not recommended.

    Dosing and Administration:
    Outwardly:
    In case of dermatomycosis, Lomexin® cream is applied to the affected areas of the skin 2 times a day with a uniform thin layer, on the previously cleaned affected areas, with the capture of approximately 1 cm of the surface of healthy skin and gently rubbed. The duration of treatment depends on the causative agent etiology and localization of the infection. Symptoms of the disease disappear, usually in 2-4 weeks. The recommended duration of treatment is 4 weeks.
    Intravaginally:
    With vulvovaginal candidiasis, vaginal trichomoniasis, Lomexin® cream (approximately 5 g) is injected deep into the vagina, in the prone position, once a day, at bedtime or, if necessary, 2 times a day - in the morning and in the evening. The course of treatment is 7 days.If necessary, repeat the course in 10 days. Treatment is conducted until complete clinical recovery.
    To avoid re-infection, it is recommended to simultaneously treat a partner with cream, which is applied to the glans penis and foreskin.
    Application of the applicator - Fig.
    After each use, rinse the applicator with warm water (not above 50 ° C) with soap and dry.
    Side effects:
    Side effects are listed according to the classification of MedDRA according to the damage to organs and organ systems and the frequency of development: very often (> 1/10), often (> 1/100 to <1/10), infrequently (>> 1/1000 to < 1/100), rarely (> 1/10 000 to <1/1000), very rarely (from <1/10 000), the frequency is unknown (the frequency can not be calculated from the available data).
    Immune system disorders: very rarely - allergic reactions (urticaria, rash, erythema).
    From the skin and subcutaneous tissues (external application): very rarely - erythema, pruritus, rash, erythematous rash, irritation and swelling.
    From the mucous membranes (with vaginal application): very rarely - itching, burning in the application area.
    If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.
    Overdose:
    Due to the low degree of absorption in the systemic blood flow, an overdose is unlikely.
    Interaction:Not studied.
    Special instructions:
    In case of accidental contact with the product, rinse with plenty of water.
    When applied to large areas of the skin, the risk of sensitization increases.
    When developing an allergic reaction, it is necessary to stop treatment, contact your doctor and begin appropriate treatment.
    If there is no effect for 4 weeks, treatment should be stopped and the diagnosis clarified.
    With vulvovaginal candidiasis and vaginal trichomoniasis: the drug can not be used during menstruation, it is advisable to start treatment after menstruation, during the use of the drug it is recommended to use reliable methods of contraception.
    Effect on the ability to drive transp. cf. and fur:There is no evidence of a negative effect of the drug on the ability to perform potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (vehicle management, work with moving mechanisms).
    Form release / dosage:

    Cream for vaginal and external use, 2%.

    Packaging:

    30 grams of cream in an aluminum tube with a screw cap. One tube with instructions for use in a cardboard bundle.

    For 78 grams of cream in an aluminum tube with a screw cap. One tube with dispenser placed in a transparent plastic case, and the instructions for use, in a cardboard bundle.

    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002508
    Date of registration:29.12.2011
    The owner of the registration certificate:RECORDATA Ireland Co., Ltd.RECORDATA Ireland Co., Ltd. Ireland
    Manufacturer: & nbsp
    Representation: & nbspRECORDINGS RECORDINGS Italy
    Information update date: & nbsp21.09.2015
    Illustrated instructions
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