Active substanceClotrimazole + MetronidazoleClotrimazole + Metronidazole
Similar drugsTo uncover
  • Clomegel
    gel the vagina. 
    SYNTHESIS, OJSC     Russia
  • Dosage form: & nbspgel, vaginal
    Composition:

    To prepare 100 g of gel:

    Active substances: clotrimazole 2.0 g, metronidazole -1.0 g

    Excipientspropylene glycol, carbomer (carbopol), methylparahydroxybenzoate (nipagin, methylparaben), propyl parahydroxybenzoate (nipazole, propylparaben), disodium edetate (disodium ethylenediaminetetraacetic acid, trilon B), benzyl alcohol, macrogol (polyethylene glycol 400), purified water.

    Description:Colorless or yellowish shade gel.
    Pharmacotherapeutic group:Antimicrobial agent combined (antimicrobial and antiprotozoal drug + antifungal agent
    ATX: & nbsp

    G.01.A.F.20   Combinations of imidazole derivatives

    Pharmacodynamics:

    Combined drug for intravaginal application, the effectiveness of which is due to the presence in its composition of two components: metronidazole and clotrimazole.

    Metronidazole is an antiprotozoal and antibacterial drug, a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group of metranidazole by intracellular transport proteins of anaerobic microorganisms and protozoa.The reduced 5-nitro group of metronidazole reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

    Active with respect to Trichomonas vaginalis, Entamoeba histolytica, as well as Gram-negative anaerobes Bacteroides spp. (including W. Fragilis, AT. distasonis, AT. ovatus, AT. thetaiotaomicron, AT. vulgatus), Fusobacterium spp., and some Gram-positive anaerobes (sensory strains Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.).

    The minimum inhibitory concentration for these strains is 0.125 - 6.25 μg / ml.

    Clotrimazole - an antifungal agent from the group of imidazole derivatives for external and local (intravaginal) use, reduces the synthesis of ergosterol, which is an integral part of the cell membrane of the fungus, and leads to a change in its structure and properties.

    In small concentrations, it acts fungistatically, and in large concentrations (more than 20 μg / ml) it is fungicidal, not only on proliferating cells. In fungicidal concentrations, it interacts with mitochondrial enzymes and peroxidases, resulting in an increase in the concentration of hydrogen peroxide to a toxic value, which also contributes to the destruction of fungal cells.

    Active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and mold fungi (Candida spp., Torulopsis glabrata, kind Rhodotorula, Pityrosporum orbiculare).

    Pharmacokinetics:

    After intravaginal administration metronidazole is subject to systemic absorption (about 56%). The relative bioavailability of the vaginal gel is 2 times higher than the bioavailability of a single dose (500 mg) of vaginal metronidazole tablets. It penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta. After a single intravaginal injection of 5 g of gel (50 mg of metronidazole), the average maximum serum concentration in healthy women is 237 mg / ml, which is 2% of the average maximum concentration of metronidazole when administered at a dose of 500 mg. The time to reach the maximum concentration is 6-12 hours. The connection with plasma proteins is less than 20%. Metabolized in the liver by hydroxylation, oxidation and glucuronation. The activity of the main metabolite (2-hydroxymethonidazole) is 30% of the activity of the parent compound. It is excreted by the kidneys and through the intestines.

    When clotrimazole is administered intravaginally, no more than 3-10% of the administered dose is absorbed.High concentrations in the vaginal secretion and low blood concentrations persist for 48-72 hours. In the liver clotrimazole Rapidly metabolized to inactive metabolites.

    Indications:Bacterial vaginosis caused by pathogens sensitive to metronidazole, confirmed by clinical and microbiological data; candidiasis vulvitis and vulvovaginitis, urogenital trichomoniasis.
    Contraindications:Hypersensitivity to the components of the drug, leukopenia (including in the history), organic damage to the central nervous system (including epilepsy), liver failure, pregnancy.
    Pregnancy and lactation:

    The use of the drug during pregnancy is contraindicated. When prescribing the drug during lactation, it is necessary to stop breastfeeding.

    Dosing and Administration:

    Intravaginal. The recommended dose is 5 g (one complete applicator) 2 times a day (morning and evening). The course of treatment is 5 days. If necessary, the course of treatment can be repeated after 2 weeks.

    Side effects:

    Local Reactions: burning sensation or frequent urination; a sexual partner - a burning sensation or irritation of the penis.

    Possible development of systemic effects: dizziness, headache, nausea, spastic abdominal pain.

    Allergic reactions: skin rash, hives.

    In case of any undesirable side effects, stop treatment and consult a doctor!

    Overdose:

    With an intravaginal route of administration, an overdose has not been established.

    Interaction:

    Metronidazole. Increases the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation.

    Similarly, disulfiram causes intolerance to ethanol.

    Simultaneous use with disulfiram can lead to the development of various neurological symptoms.Cimetidine suppresses the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of side effects. Simultaneous administration of drugs stimulating enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin), can accelerate the elimination of metronidazole, as a result of which its concentration in the plasma decreases.

    With simultaneous reception with drugs Li + may increase the concentration of the latter in the plasma and the development of symptoms of intoxication.

    It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide). Sulfonamides increase the antimicrobial effect of metronidazole.

    Clotrimazole.

    Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously.

    Special instructions:

    During the period of treatment, alcohol intake is contraindicated (development of a disulfiram-like reaction is possible: spasmodic abdominal pain, nausea, vomiting, headache, sudden "tide" of blood to the face).

    Metronidazole can immobilize treponema and lead to Nelson's false positive test.

    Only for intravaginal application!

    Avoid getting the gel in your eyes!

    During the course of treatment it is necessary to abstain from sexual activity.
    Effect on the ability to drive transp. cf. and fur:The use of the drug does not affect the management of vehicles and the maintenance of machines and mechanisms that require concentration of attention.
    Form release / dosage:

    Gel vaginal 20 mg + 10 mg / g.

    Packaging:30 g in aluminum tubes. Each tube with an applicator for intravaginal injection and with instruction for use is placed in a pack of cardboard.
    Storage conditions:

    In dry, the dark place at a temperature from 15 before 25 ° C. Freezing not allowed. Keep out of the reach of children.

    Shelf life:2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006240/10
    Date of registration:01.07.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.01.2018
    Illustrated instructions
      Instructions
      Up